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A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)

NCT00849680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2015-02-02

Study results available
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Summary

The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef

Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.

Conditions

Interventions

OTHER

Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine

Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.

BIOLOGICAL

Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)

Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose)

BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose)

BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose)

BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose)

BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose)

BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose)

BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose)

BIOLOGICAL

Comparator: Placebo to MRKAd5 HIV-1 gag vaccine

Placebo to the MRKAd5 HIV-1 gag vaccine.

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
2003-04-30
Primary Completion
2005-03-31
Completion
2010-02-28

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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 NCT00849680 on ClinicalTrials.gov