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Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107042
Recruitment Status : Completed
First Posted : April 5, 2005
Results First Posted : December 4, 2012
Last Update Posted : March 29, 2017
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Hepatitis B
Interventions Biological: Recombivax
Biological: Twinrix
Enrollment 123
Recruitment Details The study was started in February 2004 and was completed in July 2008. A total of 11 sites, all in the United States and Puerto Rico, participated in the study.
Pre-assignment Details  
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description Active Comparator: 1st dose at Week 0, 2nd dose at Week 24 Experimental: 1st dose at Week 0, 2nd dose at Week 24
Period Title: Overall Study
Started 60 63
Completed 38 47
Not Completed 22 16
Reason Not Completed
Lost to Follow-up             9             7
Withdrawal by Subject             6             1
Moved out of area             5             3
Pregnancy             1             1
Inadvertent enrollment             0             1
vaccinated outside window             1             1
Disallowed medications             0             2
Arm/Group Title Recombivax Twinrix Total
Hide Arm/Group Description Active Comparator: 1st dose at Week 0, 2nd dose at Week 24 Experimental: 1st dose at Week 0, 2nd dose at Week 24 Total of all reporting groups
Overall Number of Baseline Participants 60 63 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 63 participants 123 participants
15.02  (1.43) 15.22  (1.71) 15.12  (1.58)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 63 participants 123 participants
12 - 14 years 18 23 41
15 - 17 years 42 40 82
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 63 participants 123 participants
Female
19
  31.7%
27
  42.9%
46
  37.4%
Male
41
  68.3%
36
  57.1%
77
  62.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 63 participants 123 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
  33.3%
14
  22.2%
34
  27.6%
White
3
   5.0%
6
   9.5%
9
   7.3%
More than one race
37
  61.7%
43
  68.3%
80
  65.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Qualitative Seroresponsiveness to Hepatitis B Surface Antigen
Hide Description

Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows:

Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL.

Time Frame Week (Wk) 28 (One month after the second immunization)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were included if they were vaccinated at least once (Intent-to-Treat)
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 47 55
Measure Type: Number
Unit of Measure: Participants
Responder 41 52
Non-responder 6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Recombivax, Twinrix
Comments The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2954
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Recombivax
Comments Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "Recombivax" arm is presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Response Rate
Estimated Value 87.23
Confidence Interval (2-Sided) 95%
74.26 to 95.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Twinrix
Comments Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "'Twinrix" arm is presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Response Rate
Estimated Value 94.55
Confidence Interval (2-Sided) 95%
84.88 to 98.86
Estimation Comments [Not Specified]
2.Primary Outcome
Title Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))
Hide Description Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported.
Time Frame Week 12, Week 24, Week 28, Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline at each visit visit. The data presented are cumulative for events identified at each time point.
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 60 63
Measure Type: Number
Unit of Measure: participants
6 4
3.Primary Outcome
Title Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)
Hide Description Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. The number of participants with at least one SAE is reported.
Time Frame Week 12, Week 24, Week 28, Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline. The data presented are cumulative for events identified at each time point.
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 60 63
Measure Type: Number
Unit of Measure: participants
Asthenia 1 0
Forearm fracture 1 0
Road traffic accident 0 1
Anxiety 0 1
4.Secondary Outcome
Title Quantitative Vaccine Response
Hide Description The Log10 titer was used as the quantitative vaccine response.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had a wk 28 Hep B a'body titer and was no more than 8 wks after the 2nd vaccination were included. 1 subject was missing wk 28 titer. The a'body at week 48 was positive, so subject was treated as a responder for the binary measure. For the continuous a'body titer, the exact number could not be assumed; subject was treated as missing.
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 47 54
Mean (Standard Deviation)
Unit of Measure: Log10 titer (mIU/ml)
2.29  (0.82) 2.58  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Recombivax, Twinrix
Comments Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0608
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Recombivax
Comments Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "Recombivax" arm is presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean response
Estimated Value 2.29
Confidence Interval (2-Sided) 95%
2.05 to 2.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Twinrix
Comments Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "Twinrix" arm is presented here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Response rate
Estimated Value 2.58
Confidence Interval (2-Sided) 95%
2.40 to 2.76
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Hide Description The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Participant
Study Arm: Recombivax 34
Study Arm: Twinrix 41
Site Effect: Other Site 43
Site Effect: Baltimore 32
Age: 15 - 17 years 51
Age: 12 - 14 years 24
Gender: Female 29
Gender: Male 46
Hispanic Ethnicity: No 23
Hispanic Ethnicity: Yes 52
Racial Background: White 6
Racial Background: Other/Mixed Race 47
Racial Background: Black/African American 22
Tanner Stage for Females: Stage 5 17
Tanner Stage for Females: Stages 1 - 4 12
Tanner Stage for Males: Stage 5 15
Tanner Stage for Males: Stages 1 - 4 31
BMI at Baseline: Normal and Underweight (<25.0) 49
BMI at Baseline: Overweight and Obese (>=25.0) 26
Ever Smoked Cigarettes: No 59
Ever Smoked Cigarettes: Yes 16
Sexual Identity: Straight (Heterosexual) 67
Sexual Identity: Gay, Bi, Not Sure or Undecided 8
Age First Sex Not Forced: Never 44
Age First Sex Not Forced: <=14 Years 8
Age First Sex Not Forced: 15-17 Years 17
Total Lifetime Sex Partners: 0 Partners 44
Total Lifetime Sex Partners: 1-5 Partners 19
Total Lifetime Sex Partners: >= 6 Partners 10
Total Lifetime Male Sex Partners: 0 Partners 58
Total Lifetime Male Sex Partners: 1-5 Partners 10
Total Lifetime Male Sex Partners: >= 6 Partners 5
Total Lifetime Female Sex Partners: 0 Partners 57
Total Lifetime Female Sex Partners: 1-5 Partners 11
Total Lifetime Female Sex Partners: >= 6 Partners 5
Ever Drank Alcohol: No 45
Ever Drank Alcohol: Yes 30
Ever Smoked Marijuana: No 58
Ever Smoked Marijuana: Yes 17
Ever Used Drugs not Prescribed: No 71
Ever Used Drugs not Prescribed: Yes 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1667
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.2455
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1757
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9890
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficent
Estimated Value -0.0025
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1792
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2796
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coeffcient
Estimated Value 0.2053
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1885
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regresssion coeffcient
Estimated Value -0.4726
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1734
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2543
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.2189
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1905
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3661
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.2994
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3292
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9812
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.0083
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3497
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7766
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.0663
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2314
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2492
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.2929
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2508
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (<25.0) vs. Overweight and Obsese (>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0877
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coeffcient
Estimated Value -0.3160
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1826
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0117
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.0292
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0113
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7899
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.0578
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2163
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0607
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.5339
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2803
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. <= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between "never" vs. "<= 14 year olds" is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1670
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.3883
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2779
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. <= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between "never" vs. "15-17 year olds" is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8682
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.0344
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2065
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4219
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.1532
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1896
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.7752
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2420
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1659
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.2921
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2086
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -1.6163
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2839
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4701
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.1788
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2463
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7572
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value 0.1083
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3488
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8657
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.0307
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1809
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0917
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.3548
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2076
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection All Participants
Comments This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3788
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression coefficient
Estimated Value -0.3474
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3924
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.
Hide Description Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Wk 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 47 55
Measure Type: Number
Unit of Measure: Participants
Responder 41 52
Non-Responder 6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Recombivax, Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2068
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.54
Confidence Interval (2-Sided) 95%
0.60 to 10.76
Estimation Comments The reference group is the 'Recombivax' group.
7.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT
Hide Description Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum antibody level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Other Sites Baltimore
Hide Arm/Group Description:
All other clinical sites (besides the Baltimore site) where subjects were enrolled.
Clinical site where subjects were enrolled.
Overall Number of Participants Analyzed 47 55
Measure Type: Number
Unit of Measure: Participants
Responder 42 51
Non-Responder 5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Other Sites, Baltimore
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5524
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.38 to 6.01
Estimation Comments The reference group is the 'Other Sites' group.
8.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title 15-17 Years of Age 12-14 Years of Age
Hide Arm/Group Description:
Subjects between the ages of 15 and 17 years, inclusive
Subjects between the ages of 12 and 14 years, inclusive
Overall Number of Participants Analyzed 68 34
Measure Type: Number
Unit of Measure: Participants
Responder 61 32
Non-Responder 7 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 15-17 Years of Age, 12-14 Years of Age
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4646
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.84
Confidence Interval (2-Sided) 95%
0.36 to 9.36
Estimation Comments The reference group is the '15-17 year' age group
9.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Female Male
Hide Arm/Group Description:
Female Subjects
Male Subjects
Overall Number of Participants Analyzed 38 64
Measure Type: Number
Unit of Measure: Participants
Responder 36 57
Non-Responder 2 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Female, Male
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3390
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.09 to 2.30
Estimation Comments The reference group is the 'Female' group.
10.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Not Hispanic Hispanic
Hide Arm/Group Description:
Subjects who reported they were not of Hispanic ethnicity.
Subjects who reported they were of Hispanic ethnicity.
Overall Number of Participants Analyzed 27 75
Measure Type: Number
Unit of Measure: Participants
Responder 21 72
Non-Responder 6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Not Hispanic, Hispanic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.86
Confidence Interval (2-Sided) 95%
1.58 to 29.78
Estimation Comments The reference group is the 'Hispanic: NO' group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Not Hispanic, Hispanic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0118
Comments Since Hispanic (no, yes) was a factor with a p-value of < 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.
Method Multivariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.38
Confidence Interval (2-Sided) 95%
1.56 to 34.95
Estimation Comments The reference group is the "Hispanic: NO" group.
11.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the wk 28 titer.
Arm/Group Title White Other/Mixed Race Black/African American
Hide Arm/Group Description:
Subjects who reported their race to be white.
Subjects who reported their race to be other than white, black, or of mixed race.
Subjects who reported their race to be black or African American
Overall Number of Participants Analyzed 9 68 25
Measure Type: Number
Unit of Measure: Participants
Responder 8 66 19
Non-Responder 1 2 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection White, Black/African American
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4241
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.04 to 3.84
Estimation Comments The reference group is the 'White' group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection White, Other/Mixed Race
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2685
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.12
Confidence Interval (2-Sided) 95%
0.34 to 50.76
Estimation Comments The reference group is the 'White' group.
12.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Females who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of the Wk 28 titer.
Arm/Group Title Tanner Stage 5 (Females) Tanner Stages 1-4 (Females)
Hide Arm/Group Description:
Females who were self-assessed and categorized to Tanner Stage 5.
Females who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
Overall Number of Participants Analyzed 20 18
Measure Type: Number
Unit of Measure: Participants
Responder 19 17
Non-responder 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tanner Stage 5 (Females), Tanner Stages 1-4 (Females)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9390
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.05 to 15.44
Estimation Comments The reference group is the 'Stage 5' group.
13.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Male participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of Wk 28 titer.
Arm/Group Title Tanner Stage 5 (Males) Tanner Stages 1-4 (Males)
Hide Arm/Group Description:
Males who were self-assessed and categorized to Tanner Stage 5.
Males who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
Overall Number of Participants Analyzed 22 42
Measure Type: Number
Unit of Measure: Participants
Responder 19 38
Non-responder 3 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tanner Stage 5 (Males), Tanner Stages 1-4 (Males)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6181
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.30 to 7.39
Estimation Comments The reference group is the "Stage 5" group.
14.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Normal and Underweight (< 25.0) Overweight and Obese (>=25.0)
Hide Arm/Group Description:
Subjects whose BMIs were normal to < 25.0
Subjects whose BMIs were >= 25.0
Overall Number of Participants Analyzed 66 36
Measure Type: Number
Unit of Measure: Participants
Responder 62 31
Non-responder 4 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal and Underweight (< 25.0), Overweight and Obese (>=25.0)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1943
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.10 to 1.60
Estimation Comments The reference group is the "Normal and Underweight (<25.0)" group.
15.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Ever Smoked Cigarettes: NO Ever Smoked Cigarettes: YES
Hide Arm/Group Description:
Subjects who have never smoked cigarettes
Subjects who have smoked cigarettes
Overall Number of Participants Analyzed 82 19
Measure Type: Number
Unit of Measure: Participants
Responder 76 16
Non-responder 6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ever Smoked Cigarettes: NO, Ever Smoked Cigarettes: YES
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2542
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.10 to 1.86
Estimation Comments The reference group is the "Ever smoked cigarettes: NO" group.
16.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Straight (Heterosexual) Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided
Hide Arm/Group Description:
Subjects who were straight (heterosexual)
Subjects who were either gay (homosexual), bisexual, not sure or undecided.
Overall Number of Participants Analyzed 93 9
Measure Type: Number
Unit of Measure: Participants
Responder 87 6
Non-responder 6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Straight (Heterosexual), Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0161
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
0.03 to 0.69
Estimation Comments The reference group is the "Straight (heterosexual)" group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Straight (Heterosexual), Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0222
Comments Since sexual identity was a factor with a p-value of < 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.
Method Multivariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.02 to 0.74
Estimation Comments The reference group is the "Straight (heterosexual)" group.
17.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age of participants’ first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Never 12-14 Years of Age 15-17 Years of Age
Hide Arm/Group Description:
Subjects who reported they never had anal or vaginal sex because they wanted to.
Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 12 and 14, inclusive
Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 15 and 17, inclusive
Overall Number of Participants Analyzed 62 10 24
Measure Type: Number
Unit of Measure: Participants
Responder 59 7 23
Non-responder 3 3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Never, 15-17 Years of Age
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8945
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.12 to 11.83
Estimation Comments The reference group is the "Never" (had sex)group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Never, 12-14 Years of Age
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0190
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.02 to 0.70
Estimation Comments The reference group is the "Never" (had sex) group.
18.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title 0 Sex Partners 1 - 5 Sex Partners >= 6 Sex Partners
Hide Arm/Group Description:
Subjects who have never had a sex partner
Subjects who have had 1 - 5 lifetime sex partners
Subjects who have had 6 or more lifetime sex partners
Overall Number of Participants Analyzed 62 26 12
Measure Type: Number
Unit of Measure: Participants
Responder 59 26 7
Non-responder 3 0 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0 Sex Partners, >= 6 Sex Partners
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0042
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
0.01 to 0.48
Estimation Comments The reference group is the "0 partners" group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0 Sex Partners, 1 - 5 Sex Partners
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6893
Comments [Not Specified]
Method Univariate regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Estimation Comments

The reference group is the "0 partners" group.

Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity

19.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title 0 Male Sex Partners 1-5 Male Sex Partners >= 6 Male Sex Partners
Hide Arm/Group Description:
Male and female subjects who have never had a male sex partner
Male and female subjects who have had 1 - 5 lifetime male sex partners
Male and female subjects who have had 6 or more lifetime male sex partners
Overall Number of Participants Analyzed 82 13 5
Measure Type: Number
Unit of Measure: Participants
Responder 78 13 1
Non-responder 4 0 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0 Male Sex Partners, >= 6 Male Sex Partners
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.015
Confidence Interval (2-Sided) 95%
0.00 to 0.19
Estimation Comments The reference group is hte "0 Partners" group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0 Male Sex Partners, 1-5 Male Sex Partners
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Univariate regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.00 to 10.01
Estimation Comments The reference group is the "0 Partners" group
20.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title 0 Female Sex Partners 1-5 Female Sex Partners >= 6 Female Sex Partners
Hide Arm/Group Description:
Male and female subjects who have never had a female sex partner
Male and female Subjects who have had 1 - 5 lifetime female sex partners
Male and female subjects who have had 6 or more lifetime female sex partners
Overall Number of Participants Analyzed 78 15 7
Measure Type: Number
Unit of Measure: Participants
Responder 72 14 6
Non-responder 6 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0 Female Sex Partners, >= 6 Female Sex Partners
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5503
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.05 to 4.86
Estimation Comments The reference group is the "0 Partners" group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0 Female Sex Partners, 1-5 Female Sex Partners
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8904
Comments [Not Specified]
Method Univariate Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.13 to 10.46
Estimation Comments The reference group is the "0 Partners" group.
21.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Ever Drank Alcohol: NO Ever Drank Alcohol: YES
Hide Arm/Group Description:
Subjects who have never drank alcohol
Subjects who have drank alcohol
Overall Number of Participants Analyzed 62 40
Measure Type: Number
Unit of Measure: Participants
Responder 58 35
Non-responder 4 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ever Drank Alcohol: NO, Ever Drank Alcohol: YES
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3010
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.12 to 1.92
Estimation Comments The reference group is the "Ever drank alcohol: NO" group.
22.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Ever Smoked Marijuana: NO Ever Smoked Marijuana: YES
Hide Arm/Group Description:
Subjects who have never smoked marijuana
Subjects who have smoked marijuana
Overall Number of Participants Analyzed 83 19
Measure Type: Number
Unit of Measure: Participants
Responder 78 15
Non-responder 5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ever Smoked Marijuana: NO, Ever Smoked Marijuana: YES
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0501
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.06 to 1.00
Estimation Comments The reference group is the "Ever smoked marijuana: NO" group.
23.Secondary Outcome
Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE
Hide Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
Arm/Group Title Ever Used Drugs Not Prescribed: NO Ever Used Drugs Not Prescribed: YES
Hide Arm/Group Description:
Subjects who have never used drugs that were not prescribed.
Subjects who have used drugs that were not prescribed.
Overall Number of Participants Analyzed 97 5
Measure Type: Number
Unit of Measure: Participants
Responder 89 4
Non-responder 8 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ever Used Drugs Not Prescribed: NO, Ever Used Drugs Not Prescribed: YES
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3846
Comments [Not Specified]
Method Univariate regression, logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.04 to 3.61
Estimation Comments The reference group is the "Ever used drugs not prescribed: NO" group.
24.Secondary Outcome
Title Immunogenicity to Hep B 18 Months After First Immunization
Hide Description Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76
Time Frame Week 76
Hide Outcome Measure Data
Hide Analysis Population Description

Participants who had a week 76 Hepatitis B antibody titer were included in this analysis.

One subject had an a'body titer at EOS visit but did not have a'body data at week 76. Since the EOS was close to week 76, the titer from EOS was recoded as the week 76 titer.

Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 37 50
Measure Type: Number
Unit of Measure: Participants
Responded (>= 10mIU/ml) 30 44
Not responded (< 10mIU/ml) 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Recombivax, Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3827
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Recombivax
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Responding Rate
Estimated Value 81.08
Confidence Interval (2-Sided) 95%
68.84 to 92.04
Estimation Comments Response rate=Total number subjects responded/Total number subjects in arm
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Responding Rate
Estimated Value 88.0
Confidence Interval (2-Sided) 95%
75.69 to 95.47
Estimation Comments Response rate=Total number subjects responded/Total number subjects in arm
25.Secondary Outcome
Title Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination
Hide Description Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.
Arm/Group Title Twinrix
Hide Arm/Group Description:
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
POSITIVE (1 month post 2nd vaccination) 98.08
NEGATIVE (1 month post 2nd vaccination) 1.92
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments A p-value has not been entered because there is only one study arm in this analysis.
Method Exact 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Responding rate
Estimated Value 98.08
Confidence Interval (2-Sided) 95%
89.74 to 99.95
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination
Hide Description Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.
Time Frame Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.
Arm/Group Title Twinrix
Hide Arm/Group Description:
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
Positive (12 months post 2nd vaccination) 91.49
Negative (12 months post 2nd vaccination) 8.51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments A p-value has not been entered because there is only one study arm in this analysis.
Method Exact 95 % confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Responding Rate
Estimated Value 91.49
Confidence Interval 95%
79.62 to 97.63
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)
Hide Description Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.
Time Frame Week 28 and Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the Twinrix arm who had week 28 &/or wk 76 HepA serology results were included. For overall response analysis, if a subject was reactive at either wk 28 or wk 76, then the overall response for subject was considered “Positive”. If subject was non-reactive at both wk 28and wk 76, then the overall response for subject was “Negative”.
Arm/Group Title Twinrix
Hide Arm/Group Description:
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
Positive: overall 98.11
Negative: overall 1.89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments A p-value has not been entered because there is only one study arm in this analysis.
Method Exact 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Responding Rate %
Estimated Value 98.11
Confidence Interval (2-Sided) 95%
89.93 to 99.95
Estimation Comments For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered “Positive”. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is “Negative”.
28.Secondary Outcome
Title As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen
Hide Description The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed both vaccinations according to the protocol were included in the analysis (as treated analysis). Those who only had 1 vaccination,whose 2nd vaccination was outside the specified time window, or other cases of protocol violations, were excluded from the analysis.
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 41 47
Measure Type: Number
Unit of Measure: percentage of participants
Responded (>=10mIU/ml) 85.4 93.6
Not responded (< 10mIU/ml) 14.6 6.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Recombivax, Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2938
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Recombivax
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95 % confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Responding Rate %
Estimated Value 85.37
Confidence Interval (2-Sided) 95%
70.83 to 94.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Twinrix
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Responding Rate %
Estimated Value 93.62
Confidence Interval (2-Sided) 95%
82.46 to 98.66
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Assessment of Youth Understanding of Vaccine Trial and Informed Consent
Hide Description Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description:
Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Experimental: 1st dose at Week 0, 2nd dose at Week 24
Overall Number of Participants Analyzed 60 63
Mean (Standard Deviation)
Unit of Measure: Number of correct answers
5.18  (1.24) 5.1  (1.32)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Recombivax Twinrix
Hide Arm/Group Description Active Comparator: 1st dose at Week 0, 2nd dose at Week 24 Experimental: 1st dose at Week 0, 2nd dose at Week 24
All-Cause Mortality
Recombivax Twinrix
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Recombivax Twinrix
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/60 (3.33%)      2/63 (3.17%)    
General disorders     
Asthenia 1 [1]  1/60 (1.67%)  1 0/63 (0.00%)  0
Injury, poisoning and procedural complications     
Forearm Fracture  1 [2]  1/60 (1.67%)  1 0/63 (0.00%)  0
Road Traffic Accident  1 [3]  0/60 (0.00%)  0 1/63 (1.59%)  1
Psychiatric disorders     
Anxiety  1 [3]  0/60 (0.00%)  0 1/63 (1.59%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6.0
[1]
In Addition to MedDRA 6.0, WHODD 2003, 2nd quarter was used for coding.
[2]
WHODD 2003, 2nd quarter
[3]
WHODD 2003, 2nd quarter also used for coding
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Recombivax Twinrix
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/60 (10.00%)      4/63 (6.35%)    
Gastrointestinal disorders     
Nausea  1 [1]  1/60 (1.67%)  3 0/63 (0.00%)  0
General disorders     
Asthenia  1 [1]  1/60 (1.67%)  3 0/63 (0.00%)  0
Chest Pain  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Fatigue 1 [1]  1/60 (1.67%)  3 0/63 (0.00%)  0
Malaise  1 [1]  1/60 (1.67%)  3 0/63 (0.00%)  0
Pain NOS  1 [1]  1/60 (1.67%)  2 0/63 (0.00%)  0
Infections and infestations     
Dengue Fever  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Upper Respiratory Tract Infection NOS  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Injury, poisoning and procedural complications     
Femure Fracture  2 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Foot Fracture  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Forearm Fracture  1 [1]  1/60 (1.67%)  1 0/63 (0.00%)  0
Laceration  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Metabolism and nutrition disorders     
Appetite Decreased N OS  1 [1]  1/60 (1.67%)  3 0/63 (0.00%)  0
Nervous system disorders     
Dizziness  1 [1]  0/60 (0.00%)  0 2/63 (3.17%)  2
Headache  1 [1]  5/60 (8.33%)  7 1/63 (1.59%)  1
Tremor  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Psychiatric disorders     
Anxiety  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Panic Attack  1 [1]  0/60 (0.00%)  0 1/63 (1.59%)  1
Surgical and medical procedures     
Appendectomy  1 [1]  1/60 (1.67%)  1 0/63 (0.00%)  0
Internal Fixation of Fracture  1 [1]  1/60 (1.67%)  1 0/63 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6.0
2
Term from vocabulary, MedDRA 6
[1]
WHODD 2003, 2nd quarter also used for coding
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bob Harris
Organization: Westat
Phone: 301-251-1500
EMail: bobharris@westat.com
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00107042     History of Changes
Other Study ID Numbers: ATN 025
First Submitted: April 4, 2005
First Posted: April 5, 2005
Results First Submitted: September 5, 2011
Results First Posted: December 4, 2012
Last Update Posted: March 29, 2017