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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004579
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 2003
History of Changes

November 2, 1999
June 23, 2005
April 1998
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Complete list of historical versions of study NCT00004579 on ClinicalTrials.gov Archive Site
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A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
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

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • HIV Seronegativity
  • Biological: gp160 MN/LAI-2
  • Biological: ALVAC-HIV MN120TMG (vCP205)
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004579
RV124
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Walter Reed Army Institute of Research (WRAIR)
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Principal Investigator: Jerome H. Kim
NIH AIDS Clinical Trials Information Service
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP