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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004579
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV Seronegativity Biological: gp160 MN/LAI-2 Biological: ALVAC-HIV MN120TMG (vCP205) Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Masking: Double
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
Study Start Date : April 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004579

United States, Maryland
Walter Reed Army Institute of Research
Rockville, Maryland, United States
Sponsors and Collaborators
Walter Reed Army Institute of Research (WRAIR)
Principal Investigator: Jerome H. Kim

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)

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00004579     History of Changes
Other Study ID Numbers: RV124
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2003

Keywords provided by NIH AIDS Clinical Trials Information Service:
Vaccines, Synthetic
Viral Vaccines
Dose-Response Relationship, Drug
HIV Envelope Protein gp160
AIDS Vaccines
HIV Seronegativity
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
Immunologic Factors
Physiological Effects of Drugs