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A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)

NCT00849732 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2015-02-27

No results posted yet for this study

Summary

This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10\^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10\^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10\^9 vp/d, at 1x10\^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.

Conditions

Interventions

BIOLOGICAL

V520

Intentionally Blank

BIOLOGICAL

Comparator: V520 (1x10^9 vp/d)

1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10\^9 vp/d given at Day 1, Week 4, and Week 26

BIOLOGICAL

Comparator: V520 (1x10^10 vp/d)

1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10\^10 vp/d given at Day 1, Week 4, and Week 26

BIOLOGICAL

Comparator: Placebo

Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Merck Sharp & Dohme LLC

    lead INDUSTRY

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2006-10-31
Completion
2011-02-28

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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 NCT00849732 on ClinicalTrials.gov