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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Walter Reed Army Institute of Research (WRAIR)
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00004579

Purpose

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.

Condition	Intervention	Phase
HIV Infections HIV Seronegativity	Biological: gp160 MN/LAI-2 Biological: ALVAC-HIV MN120TMG (vCP205)	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Study Start Date:

April 1998

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004579

Locations

United States, Maryland
Walter Reed Army Institute of Research
Rockville, Maryland, United States

Sponsors and Collaborators

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

Jerome H. Kim

More Information

Publications:

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)

ClinicalTrials.gov Identifier:	NCT00004579 History of Changes
Other Study ID Numbers:	RV124
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Vaccines, Synthetic
Viral Vaccines
HIV-1
Dose-Response Relationship, Drug
HIV Envelope Protein gp160
AIDS Vaccines

HIV Seronegativity
Avipoxvirus
Immunization
HIV Envelope Protein gp120
Recombination, Genetic

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 12, 2012