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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095576
First Posted: November 8, 2004
Last Update Posted: October 6, 2015
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.
Collaborator:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide 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) ]

Measure Type Primary
Measure Title Number of Participants With Clinical Adverse Experiences
Measure Description

Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine.

AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210).

Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.

Time Frame Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)  

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.

Measured Values
   Trivalent MRKAd5 HIV-1 Gag/Pol/Nef   Placebo 
Participants Analyzed 
[Units: Participants]
 1484   1495 
Number of Participants With Clinical Adverse Experiences 
[Units: Participants]
   
With non-serious adverse events (NSAE)   1221   946 
With no non-serious adverse events   263   549 
With serious adverse events   19   17 
With no serious adverse events   1465   1478 

No statistical analysis provided for Number of Participants With Clinical Adverse Experiences



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

Measure Type Primary
Measure Title Number of Participants With Laboratory Adverse Experiences
Measure Description

Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine.

Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.

All laboratory AEs were collected up to 14 days after any vaccine dose.

Time Frame Day 1 to Week 208  

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.

Measured Values
   Trivalent MRKAd5 HIV-1 Gag/Pol/Nef   Placebo 
Participants Analyzed 
[Units: Participants]
 1484   1495 
Number of Participants With Laboratory Adverse Experiences 
[Units: Participants]
 0   0 

No statistical analysis provided for Number of Participants With Laboratory Adverse Experiences



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) ]

Measure Type Primary
Measure Title Number of Participants With HIV-1 Infections
Measure Description The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.
Time Frame Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)  

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.
An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.

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.

Measured Values
   Trivalent MRKAd5 HIV-1 Gag/Pol/Nef   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Number of Participants With HIV-1 Infections       

No statistical analysis provided for Number of Participants With HIV-1 Infections



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) ]

Measure Type Primary
Measure Title HIV-1 Viral Load in Infected Participants
Measure Description Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.
Time Frame Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)  

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.
An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.

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.

Measured Values
   Trivalent MRKAd5 HIV-1 Gag/Pol/Nef   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
HIV-1 Viral Load in Infected Participants       

No statistical analysis provided for HIV-1 Viral Load in Infected Participants




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00095576     History of Changes
Obsolete Identifiers: NCT00770549
Other Study ID Numbers: V520-023
2004_091
First Submitted: November 5, 2004
First Posted: November 8, 2004
Results First Submitted: July 20, 2011
Results First Posted: August 15, 2011
Last Update Posted: October 6, 2015