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Clinical Trial: A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
This study has been completed.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections HIV Seronegativity | Vaccine: gp160 MN/LAI-2 Vaccine: ALVAC-HIV MN120TMG (vCP205) | Phase I |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Prevention, Double-Blind, Safety Study
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: April 1998
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 - 55 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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.
Location Information
Maryland
Walter Reed Army Institute of Research, Rockville, Maryland, United States
Jerome H. Kim, Principal Investigator
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)
Record last reviewed: June 2003
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00004579
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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