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Trial record 42 of 1403 for:    Peru

Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers (Girasol)

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ClinicalTrials.gov Identifier: NCT00925288
Recruitment Status : Completed
First Posted : June 22, 2009
Results First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
NGO Via Libre
Universidad Peruana Cayetano Heredia
Information provided by (Responsible Party):
Neal Halsey, Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Human Papillomavirus Infection
Intervention Biological: Gardasil
Enrollment 200
Recruitment Details FSWs 18-26 years of age were recruited in person between August 28, 2009 and March 3, 2010 from 49 different sex locales in Lima, Peru by trained medical staff and 8 health promoters. If they fulfilled inclusion criteria, women were asked to report to the study clinic for completion of surveys, vaccination, Pap smears, and counseling.
Pre-assignment Details Some eligible participants provided a false phone number, did not show up for their study appointment, refused to use birth control when receiving vaccine doses, and reported not having time to participate in the study. After the survey and Pap smear, vaccination was the final step in study enrollment.
Arm/Group Title Regular Schedule Modified Schedule
Hide Arm/Group Description Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
Period Title: Overall Study
Started 100 100
Completed 91 93
Not Completed 9 7
Reason Not Completed
Lost to Follow-up             9             7
Arm/Group Title Regular Schedule Modified Schedule Total
Hide Arm/Group Description Duration: 0,2,6 months Duration: 0,3,6 months Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
100
 100.0%
100
 100.0%
200
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
22.86  (2.33) 22.97  (2.17) 22.92  (3.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
100
 100.0%
100
 100.0%
200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Peru Number Analyzed 100 participants 100 participants 200 participants
100 100 200
1.Primary Outcome
Title Antibody Response to HPV Vaccine for HPV 6,11,16,18.
Hide Description We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.
Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.
Arm/Group Title Regular Schedule Modified Schedule
Hide Arm/Group Description:
Duration: 0,2,6 months
Duration: 0,3,6 months
Overall Number of Participants Analyzed 89 93
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milli Merck Units
HPV 6
1086.49
(854.16 to 1382.0)
1054.13
(808.42 to 1374.53)
HPV11
745.06
(588.82 to 942.76)
776.84
(644.03 to 936.21)
HPV16
3235.89
(2661.93 to 3933.61)
2704.62
(2301.71 to 3178.06)
HPV18
603.39
(487.81 to 746.35)
531.66
(441.68 to 639.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regular Schedule, Modified Schedule
Comments The null hypothesis is that both schedules will provide an equivalent antibody response.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Since the standard schedule is at (0, 2, 6 months), and the modified schedule at (0, 3, 6 months), we will consider this a non-inferiority study. With 80% power, type 1 error of 0.05, standard deviations of 0.6, and an equivalence margin of 0.3, 64 women are needed per group to detect non-inferiority. Having 100 women in each study arm will yield over 94% power to detect non-inferiority of the modified schedule.
Statistical Test of Hypothesis P-Value >0.20
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Primary Outcome
Title Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.
Hide Description Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included
Arm/Group Title Regular Schedule Modified Schedule
Hide Arm/Group Description:
Duration: 0,2,6 months
Duration: 0,3,6 months
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
91 93
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regular Schedule, Modified Schedule
Comments Completion rates compared in the 2 study arms
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers
Hide Description Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis for baseline HPV DNA prevalence
Arm/Group Title Regular Schedule Modified Schedule
Hide Arm/Group Description:
Duration: 0,2,6 months
Duration: 0,3,6 months
Overall Number of Participants Analyzed 99 100
Measure Type: Number
Unit of Measure: participants
21 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regular Schedule, Modified Schedule
Comments comparison of differences in HPV DNA prevalence by study arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers
Hide Description Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.
Time Frame Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who listed doubts about the vaccine are counted here.
Arm/Group Title Regular Schedule Modified Schedule
Hide Arm/Group Description:
Participants in 0,2,6 month study arm
Participants in 0,3,6 month study arm
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
26 20
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regular Schedule Modified Schedule
Hide Arm/Group Description Duration: 0,2,6 months Duration: 0,3,6 months
All-Cause Mortality
Regular Schedule Modified Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Regular Schedule Modified Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/200 (0.00%)   0/200 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Regular Schedule Modified Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/200 (0.00%)   0/200 (0.00%) 
Small time difference between study arms (0,2,6 and 0,3,6 months); We cannot distinguish between antibodies resulting from vaccination and antibodies resulting from natural HPV infection;
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brandon Brown
Organization: Johns Hopkins University
Phone: 949-266-4401
EMail: bbrown@jhsph.edu
Publications:
Layout table for additonal information
Responsible Party: Neal Halsey, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00925288     History of Changes
Other Study ID Numbers: Merck IISP 35706
IRB00001625
First Submitted: June 3, 2009
First Posted: June 22, 2009
Results First Submitted: July 3, 2012
Results First Posted: October 11, 2012
Last Update Posted: October 11, 2012