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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
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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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    Trivalent MRKAd5 HIV-1 Gag/Pol/Nef   Placebo
Total, other (not including serious) adverse events     
# participants affected / at risk   1221/1484 (82.28%)   946/1495 (63.28%) 
Gastrointestinal disorders     
Diarrhoea     
# participants affected / at risk   156/1484 (10.51%)   148/1495 (9.90%) 
# events   195   182 
Nausea     
# participants affected / at risk   94/1484 (6.33%)   75/1495 (5.02%) 
# events   114   87 
General disorders     
Fatigue     
# participants affected / at risk   170/1484 (11.46%)   120/1495 (8.03%) 
# events   218   149 
Fever     
# participants affected / at risk   376/1484 (25.34%)   309/1495 (20.67%) 
# events   631   548 
General body pain     
# participants affected / at risk   76/1484 (5.12%)   23/1495 (1.54%) 
# events   98   26 
Injection site erythema     
# participants affected / at risk   317/1484 (21.36%)   143/1495 (9.57%) 
# events   448   197 
Injection site pain     
# participants affected / at risk   961/1484 (64.76%)   475/1495 (31.77%) 
# events   1862   702 
Injection site swelling     
# participants affected / at risk   337/1484 (22.71%)   115/1495 (7.69%) 
# events   511   149 
Injection site tenderness     
# participants affected / at risk   271/1484 (18.26%)   81/1495 (5.42%) 
# events   374   92 
Nervous system disorders     
Headache     
# participants affected / at risk   461/1484 (31.06%)   394/1495 (26.35%) 
# events   734   631 
Respiratory, thoracic and mediastinal disorders     
Sore throat     
# participants affected / at risk   83/1484 (5.59%)   83/1495 (5.55%) 
# events   96   90 



  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.


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