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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 5, 2015
Last verified: October 2015
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 
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
  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
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Time Frame No text entered.
Additional Description 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.

Serious Adverse Events
    Trivalent MRKAd5 HIV-1 Gag/Pol/Nef   Placebo
Total, serious adverse events     
# participants affected / at risk   19/1484 (1.28%)   17/1495 (1.14%) 
Blood and lymphatic system disorders     
Anemia aggravated     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Congenital, familial and genetic disorders     
Congenital cardiovascular anomaly     
# participants affected / at risk   0/1484 (0.00%)   2/1495 (0.13%) 
# events   0   2 
Hypoplastic left heart syndrome     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Unspecified congenital anomaly of heart     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Ventricular septal defect     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Gastrointestinal disorders     
Acute diarrhoea     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
General disorders     
Fever     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Rigors     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Hepatobiliary disorders     
Cholecystitis acute     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Immune system disorders     
Drug hypersensitivity     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Infections and infestations     
Appendicitis     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Gastroenteritis viral     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Pulmonary tuberculosis     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Shunt infection     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Staphylococcal abscess     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Vulval abscess     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Injury, poisoning and procedural complications     
Asbestosis     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Gun shot wound     
# participants affected / at risk   1/1484 (0.07%)   1/1495 (0.07%) 
# events   1   1 
Overdose     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Stab wound     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Traumatic brain injury     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Metabolism and nutrition disorders     
Dehydration     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Musculoskeletal and connective tissue disorders     
Low back pain     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Musculoskeletal pain     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Slipped disc     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Uterine fibroids     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Nervous system disorders     
Headache     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Psychiatric disorders     
Depression     
# participants affected / at risk   1/1484 (0.07%)   1/1495 (0.07%) 
# events   1   1 
Depression aggravated     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Depressive episode     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Manic episode     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Polysubstance dependence     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Substance abuse     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Suicide attempt     
# participants affected / at risk   0/1484 (0.00%)   1/1495 (0.07%) 
# events   0   1 
Renal and urinary disorders     
Kidney stone     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Respiratory, thoracic and mediastinal disorders     
Exacerbation of asthma     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Pleural effusion     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Respiratory distress     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 
Vascular disorders     
Hypertension     
# participants affected / at risk   1/1484 (0.07%)   0/1495 (0.00%) 
# events   1   0 




  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: 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
Study First Received: November 5, 2004
Results First Received: July 20, 2011
Last Updated: October 5, 2015
Health Authority: United States: Food and Drug Administration