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V710 First-In-Man (FIM) Study (V710-001)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00303069
First received: March 13, 2006
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
Results First Received: September 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Staphylococcal Infections
Interventions: Biological: V710
Biological: Comparator: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase I; First Subject In: 06-Dec-2005; Last Subject Out: 31-Jul-2006. Enrollment occurred at 6 investigative sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subject was 18 to 55 years old; in good physical health based upon medical history, physical exam, and screening tests; able to understand study procedures and provided written consent; willing and able to complete entire study; and (if female) provided negative urine pregnancy test before vaccination and using an accepted method of birth control.

Reporting Groups
  Description
V710 5 μg

Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).

Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.
V710 30 μg

Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).

Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.
V710 90 μg

Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).

Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.
Placebo

Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).

Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.

Participant Flow:   Overall Study
    V710 5 μg     V710 30 μg     V710 90 μg     Placebo  
STARTED     31     28     34     31  
COMPLETED     29     28     33     29  
NOT COMPLETED     2     0     1     2  
Lost to Follow-up                 1                 0                 0                 2  
subject moved                 1                 0                 0                 0  
Recruitment into Army Reserves                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
V710 5 μg V710 5 μg single dose at baseline.
V710 30 μg V710 30 μg single dose at baseline.
V710 90 μg V710 90 μg single dose at baseline.
Placebo Saline placebo single dose at baseline.
Total Total of all reporting groups

Baseline Measures
    V710 5 μg     V710 30 μg     V710 90 μg     Placebo     Total  
Number of Participants  
[units: participants]
 		  31     28     34     31     124  
Age, Customized  
[units: participants]
 		         
17 years of age and under     0     0     0     0     0  
18 to 29 years of age     10     5     8     10     33  
30 to 39 years of age     7     8     12     5     32  
40 to 49 years of age     11     8     11     11     41  
50 to 55 years of age     3     7     3     5     18  
Over 55 years of age     0     0     0     0     0  
Gender  
[units: participants]
 		         
Female     13     21     16     18     68  
Male     18     7     18     13     56  
Race/Ethnicity, Customized  
[units: participants]
 		         
Asian     3     0     1     3     7  
Black     9     8     4     4     25  
Hispanic-American     1     1     2     0     4  
Multiracial     0     0     1     1     2  
Native American     0     0     0     2     2  
White     18     19     26     21     84  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Vaccine-related Serious Adverse Experiences Following Vaccination   [ Time Frame: Through Day 84 postvaccination ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination   [ Time Frame: Baseline and Day 14 postvaccination ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination   [ Time Frame: Baseline and Day 7 postvaccination ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00303069     History of Changes
Other Study ID Numbers: 2010_523, V710-001, Formally IRB#0602011
Study First Received: March 13, 2006
Results First Received: September 23, 2010
Last Updated: September 23, 2010
Health Authority: United States: Food and Drug Administration