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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: HIV-1; HIV Infections

Treatments: Biological: Comparator: Placebo; Biological: Comparator: V520 (1x10^9 vp/d); Biological: V520; Biological: Comparator: V520 (1x10^10 vp/d)

Study type: Interventional

Funder types: NETWORK; Industry; NIH

Identifiers

NCT00849732

V520-018

2009_549

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

V520 (1x10\^9 vp/d)

Treatment:

Biological: V520

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

2

Experimental group

Description:

V520 (1x10\^10 vp/d)

Treatment:

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

3

Placebo Comparator group

Description:

Placebo to V520

Treatment:

Biological: Comparator: Placebo