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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

O'Connell RJ, Excler JL, Polonis VR, Ratto-Kim S, Cox J, Jagodzinski LL, Liu M, Wieczorek L, McNeil JG, El-Habib R, Michael NL, Gilliam BL, Paris R, VanCott TC, Tomaras GD, Birx DL, Robb ML, Kim JH. Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene. J Infect Dis. 2016 Jun 15;213(12):1946-54. doi: 10.1093/infdis/jiw059. Epub 2016 Feb 11.

ClinicalTrials.gov Identifier:	NCT00004579 History of Changes
Other Study ID Numbers:	RV124
First Posted:	August 31, 2001
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