Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)

This study has been terminated.
Sponsor:
Collaborator:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00095576
First received: November 5, 2004
Last updated: October 8, 2014
Last verified: October 2014
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: AIDS
HIV Infections
Interventions: Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)
Drug: 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

3000 participants were enrolled and randomized in the study. However, only 2979 received study vaccination, and are included in the started population.

V520-023 was terminated early based on findings at a planned interim analysis and subjects were encouraged to participate in the V520-030 rollover study for additional long term follow up.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
Placebo Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.

Participant Flow:   Overall Study
    Trivalent MRKAd5 HIV-1 Gag/Pol/Nef     Placebo  
STARTED     1484     1495  
VACCINATED AT VISIT 2 (Dose 1)     1484     1495  
VACCINATED AT VISIT 4 (Dose 2)     1426     1443  
VACCINATED AT VISIT 7 (Dose 3)     1328     1361  
COMPLETED     9 [1]   14 [1]
NOT COMPLETED     1475     1481  
Adverse Event                 5                 3  
Lost to Follow-up                 233                 229  
Protocol Violation                 1                 0  
Withdrawal by Subject                 34                 47  
Option to switch to a rollover study                 1097                 1099  
Site terminated                 75                 67  
Subject moved                 30                 36  
[1] Subjects not completing entire study were eligible for observational long term follow up in V520-030



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
Placebo Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
Total Total of all reporting groups

Baseline Measures
    Trivalent MRKAd5 HIV-1 Gag/Pol/Nef     Placebo     Total  
Number of Participants  
[units: participants]
  1484     1495     2979  
Age  
[units: years]
Mean ± Standard Deviation
  29.9  ± 7.8     30.2  ± 8.13     30.1  ± 7.97  
Gender  
[units: participants]
     
Female     565     570     1135  
Male     919     925     1844  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Clinical Adverse Experiences   [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ]

2.  Primary:   Number of Participants With Laboratory Adverse Experiences   [ Time Frame: Day 1 to Week 208 ]

3.  Primary:   Number of Participants With HIV-1 Infections   [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ]

4.  Primary:   HIV-1 Viral Load in Infected Participants   [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The DSMB (Data & Safety Monitoring Board) reviewed interim data which demonstrated that the investigational vaccine was not effective, and all vaccinations were halted. Long term follow up was available for participants in V520-030.


  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.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck, Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:
Publications automatically indexed to this study:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00095576     History of Changes
Obsolete Identifiers: NCT00770549
Other Study ID Numbers: V520-023, 2004_091
Study First Received: November 5, 2004
Results First Received: July 20, 2011
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration