A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection

HIV Infections Clinical Trial

Official title:

A Phase I, Dose-Ranging Trial of the Pasteur Merieux Connaught (PMC) Oligomeric HIV-1 gp160MN/LAI-2 Vaccine Alone or Primed With Live Recombinant ALVAC-HIV (vCP205) in HIV Seronegative Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004579
• Other study ID #: RV124
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005
• Start date: April 1998

Study information

• Verified date: June 2003
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.

Description:

This study consists of 2 parts:

Part A: Dose-escalation protocol using oligomeric gp160MN/LAI-2. Part B: Placebo-controlled, randomized, double-blind (within arm) study of vCP205 priming with gp160MN/LAI-2 boosting.

Volunteers are followed for at least 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

Volunteers may be eligible for this study if they:

• Are HIV-negative.

• Are in good health.

• Are between ages 18 and 55.

• Are available for at least 1 year.

• Are a resident of the United States of America.

• Agree to practice sexual abstinence or use birth control.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

• Have ever been given an HIV vaccine or certain other vaccines. (However, rabies vaccines are allowed.)

• Participate in activities that place them at high-risk for HIV infection, such as injection drug use or unprotected sex with someone who has HIV infection.

• Have certain psychiatric, medical, or substance abuse problems.

• Are allergic to eggs or other vaccines.

• Are an employee at a participating site and have access to study information.

• Are taking certain medications.

• Have received blood transfusions within 3 months before entering this study.

• Are pregnant or breast-feeding.

Study Design

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV Seronegativity

Intervention

Biological:
• gp160 MN/LAI-2

• ALVAC-HIV MN120TMG (vCP205)

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kim J, Robb M, Cox J, Ratto-Kim S, Vancott T, Zahwa H, Malia J, Chaddic C, El Habib R, Caudrelier P, Klein M, Excler JL, Birx D, McNeil J. Humoral and cellular HIV-specific responses induced by the prime-boost combination of Aventis-Pasteur ALVAC-HIV (vCP205) and oligomeric HIV-1 gp160MN/LAI-2 in HIV-uninfected adults. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 179)