A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
This study has been completed.
Sponsor:
Walter Reed Army Institute of Research (WRAIR)
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| 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:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Study Start Date: | 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004579
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:
|
HIV-1 HIV Envelope Protein gp160 HIV Seronegativity HIV Envelope Protein gp120 Vaccines, Synthetic Viral Vaccines |
Dose-Response Relationship, Drug AIDS Vaccines Avipoxvirus Immunization Recombination, Genetic |
Additional relevant MeSH terms:
|
HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015