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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers

2014-08-27 03:59:48 | BioPortfolio

Summary

To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative volunteers.

ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease.

Description

ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease.

Volunteers are randomized to receive doses of ALVAC-HIV vCP205 or ALVAC-HIV vCP65 control or both according to varying schedules over 12 months (was 6 months, amended 11/17/95) with a 12 month follow up. [AS PER AMENDMENT 5/29/98: One additional follow-up visit is required at 30-36 months.]

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

HIV Infections

Intervention

ALVAC-HIV MN120TMG (vCP205), ALVAC-RG Rabies Glycoprotein (vCP65), rgp120/HIV-1 SF-2

Location

Univ of Alabama at Birmingham
Birmingham
Alabama
United States
35294

Status

Completed

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:48-0400

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Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...


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