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

NCT00095576 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2015-10-06

Study results available
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Summary

This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.

On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.

Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.

Conditions

  • AIDS
  • HIV Infections

Interventions

BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10\^10 adenovirus genomes \[ad-vg\]/dose). This dose is equivalent to 3x10\^10 vp/dose used in study V520-016.

DRUG

Comparator: placebo

Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2007-09-30
Completion
2009-09-30

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00095576 on ClinicalTrials.gov