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

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ClinicalTrials.gov Identifier: NCT00095576
Recruitment Status : Terminated
First Posted : November 8, 2004
Results First Posted : August 15, 2011
Last Update Posted : October 6, 2015
Sponsor:
Collaborator:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Enrollment 3000
Recruitment Details

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  
Arm/Group Title Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 1484 1495 2979
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1484 participants 1495 participants 2979 participants
29.9  (7.8) 30.2  (8.13) 30.1  (7.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1484 participants 1495 participants 2979 participants
Female
565
  38.1%
570
  38.1%
1135
  38.1%
Male
919
  61.9%
925
  61.9%
1844
  61.9%
1.Primary Outcome
Title Number of Participants With Clinical Adverse Experiences
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1484 1495
Measure Type: Number
Unit of Measure: 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
2.Primary Outcome
Title Number of Participants With Laboratory Adverse Experiences
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1484 1495
Measure Type: Number
Unit of Measure: Participants
0 0
3.Primary Outcome
Title Number of Participants With HIV-1 Infections
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title HIV-1 Viral Load in Infected Participants
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/1484 (1.28%)      17/1495 (1.14%)    
Blood and lymphatic system disorders     
Anemia aggravated  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Congenital, familial and genetic disorders     
Congenital cardiovascular anomaly  0/1484 (0.00%)  0 2/1495 (0.13%)  2
Hypoplastic left heart syndrome  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Unspecified congenital anomaly of heart  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Ventricular septal defect  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Gastrointestinal disorders     
Acute diarrhoea  0/1484 (0.00%)  0 1/1495 (0.07%)  1
General disorders     
Fever  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Rigors  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Infections and infestations     
Appendicitis  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Gastroenteritis viral  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Pulmonary tuberculosis  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Shunt infection  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Staphylococcal abscess  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Vulval abscess  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Injury, poisoning and procedural complications     
Asbestosis  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Gun shot wound  1/1484 (0.07%)  1 1/1495 (0.07%)  1
Overdose  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Stab wound  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Traumatic brain injury  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Musculoskeletal and connective tissue disorders     
Low back pain  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Musculoskeletal pain  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Slipped disc  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Uterine fibroids  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Nervous system disorders     
Headache  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Psychiatric disorders     
Depression  1/1484 (0.07%)  1 1/1495 (0.07%)  1
Depression aggravated  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Depressive episode  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Manic episode  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Polysubstance dependence  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Substance abuse  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Suicide attempt  0/1484 (0.00%)  0 1/1495 (0.07%)  1
Renal and urinary disorders     
Kidney stone  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Exacerbation of asthma  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Pleural effusion  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Respiratory distress  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Vascular disorders     
Hypertension  1/1484 (0.07%)  1 0/1495 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1221/1484 (82.28%)      946/1495 (63.28%)    
Gastrointestinal disorders     
Diarrhoea  156/1484 (10.51%)  195 148/1495 (9.90%)  182
Nausea  94/1484 (6.33%)  114 75/1495 (5.02%)  87
General disorders     
Fatigue  170/1484 (11.46%)  218 120/1495 (8.03%)  149
Fever  376/1484 (25.34%)  631 309/1495 (20.67%)  548
General body pain  76/1484 (5.12%)  98 23/1495 (1.54%)  26
Injection site erythema  317/1484 (21.36%)  448 143/1495 (9.57%)  197
Injection site pain  961/1484 (64.76%)  1862 475/1495 (31.77%)  702
Injection site swelling  337/1484 (22.71%)  511 115/1495 (7.69%)  149
Injection site tenderness  271/1484 (18.26%)  374 81/1495 (5.42%)  92
Nervous system disorders     
Headache  461/1484 (31.06%)  734 394/1495 (26.35%)  631
Respiratory, thoracic and mediastinal disorders     
Sore throat  83/1484 (5.59%)  96 83/1495 (5.55%)  90
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.
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.

As this study is part of a multicenter trial, publications derived from this study should include input from the principal investigator, his/her colleagues, the other investigators in this trial, and SPONSOR personnel.

The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.

Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme
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