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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1 HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

V520 (1x10\^9 vp/d)

Group Type EXPERIMENTAL

V520

Intervention Type BIOLOGICAL

Intentionally Blank

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

Intervention Type BIOLOGICAL

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

2

V520 (1x10\^10 vp/d)

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

3

Placebo to V520

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

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

Interventions

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V520

Intentionally Blank

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

Comparator: Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject is in good general health
* Subject tests negative for Hepatitis B, Hepatitis C, and HIV
* Subjects of reproductive potential agree to use an accepted method of birth control through the entire study

Exclusion Criteria

* Subject has a recent history of fever at time of vaccination
* Subject has received immune globulin or blood product 3 months prior to injection
* Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
* Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
* Subject has a chronic medical condition that is considered progressive
* Subject has history of malignancy
* Subject weighs less than 105 lb.
* Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
* Subject has contraindication to intramuscular injection
* Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
* Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes