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

A Worldwide, Phase I, Dose-Escalating Study of Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00849732

Enrollment

360

Registered

2009-02-24

Start date

2003-06-30

Completion date

2011-02-28

Last updated

2015-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1, HIV Infections

Keywords

HIV Seronegativity, Preventive Vaccine

Brief 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.

Interventions

BIOLOGICALV520

Intentionally Blank

BIOLOGICALComparator: 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

BIOLOGICALComparator: 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

BIOLOGICALComparator: Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine	4 weeks after third vaccination

Secondary

Measure	Time frame
breadth of immune response measured by several assays	4 weeks after third vaccination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026