Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: HIV Infections

Treatments: Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520); Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520); Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350623

2006_501

V520-027

Details and patient eligibility

About

This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.

Enrollment: 210 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Demonstrates good general health
• Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
• Low risk of acquiring HIV infection
• ALT lab value within normal range

Exclusion criteria

• Previously received an investigational HIV vaccine
• Has a known or suspected impairment of immunologic function
• Has a clinically significant chronic medical condition that is considered progressive
• Has a major psychiatric illness
• Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
• Weighs less than 105 lbs.
• Has a recent (within two years) history of chronic alcohol abuse
• Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
• Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
• Male subject is planning to impregnate or provide sperm donation during the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups

MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose

Experimental group

Description:

MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Treatment:

Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)

MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose

Experimental group

Description:

MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Treatment:

Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)

MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose

Experimental group

Description:

MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Treatment:

Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)