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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

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

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

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

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

3-dose regimen of 1.0-mL intramuscular injections of 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.

Interventions

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

3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Intervention Type BIOLOGICAL

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

3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Intervention Type BIOLOGICAL

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

3-dose regimen of 1.0-mL intramuscular injections of 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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V520 V520 V520

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes