A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
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ClinicalTrials.gov Identifier: NCT00004579 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections HIV Seronegativity | Biological: gp160 MN/LAI-2 Biological: ALVAC-HIV MN120TMG (vCP205) | Phase 1 |
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 |


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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00004579
United States, Maryland | |
Walter Reed Army Institute of Research | |
Rockville, Maryland, United States |
Principal Investigator: | Jerome H. Kim |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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:
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 Acquired Immunodeficiency Syndrome Infection 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 Vaccines Immunologic Factors Physiological Effects of Drugs |