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A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00849680
First received: February 20, 2009
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: June 9, 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: HIV-1
HIV Infections
Interventions: Other: Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine
Biological: Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)
Biological: Comparator: Placebo to MRKAd5 HIV-1 gag vaccine

  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
317 participants were randomized. 2 did not receive any study medication. Therefore, the safety population was 315.

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
Placebo 2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose) 3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose) 2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.

Participant Flow:   Overall Study
    Placebo     Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)  
STARTED     27     13     42     42     42     42     78     31  
COMPLETED     16     10     27     28     32     27     61     23  
NOT COMPLETED     11     3     15     14     10     15     17     8  
Adverse Event                 0                 0                 0                 0                 0                 0                 2                 0  
Lost to Follow-up                 7                 3                 12                 11                 8                 11                 12                 5  
Subject moved                 1                 0                 3                 1                 0                 2                 2                 2  
Withdrawal by Subject                 2                 0                 0                 2                 2                 2                 1                 1  
Subject unable to comply with protocol                 1                 0                 0                 0                 0                 0                 0                 0  



  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
Placebo 2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose) 3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose) 2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose) 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
Total Total of all reporting groups

Baseline Measures
    Placebo     Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)     Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)     Total  
Number of Participants  
[units: participants]
  27     13     42     42     42     42     78     31     317  
Age, Customized  
[units: Years]
Mean ( Full Range )
  32.4  
  ( 19 to 50 )  
  34.3  
  ( 18 to 46 )  
  33.2  
  ( 19 to 50 )  
  32.6  
  ( 19 to 50 )  
  33.3  
  ( 18 to 50 )  
  34.0  
  ( 18 to 50 )  
  35.7  
  ( 19 to 50 )  
  34.8  
  ( 19 to 50 )  
  34.0  
  ( 18 to 50 )  
Gender  
[units: participants]
                 
Female     19     12     21     14     17     21     31     14     149  
Male     8     1     21     28     25     21     47     17     168  
Region of Enrollment  
[units: participants]
                 
United States     27     13     42     42     42     42     78     31     317  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Experiences   [ Time Frame: up to 260 weeks after first vaccination ]

2.  Primary:   Number of Participants With Laboratory Adverse Experiences   [ Time Frame: up to 260 weeks after first vaccination ]

3.  Primary:   Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen   [ Time Frame: 4 weeks after booster injection ]

4.  Primary:   Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen   [ Time Frame: 4 weeks after booster injection ]


  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
An interim analysis of a related study, V520 Protocol 023 (NCT00095576), showed that the MRKAd5 vaccine used in Protocol 016 (NCT00849680) was not efficacious; therefore, only a high level summary of the safety data was performed.


  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 Corp.
e-mail: clinicaltrialsdisclosure@merck.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00849680     History of Changes
Other Study ID Numbers: V520-016, 2009_548
Study First Received: February 20, 2009
Results First Received: June 9, 2011
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration