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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections HIV Seronegativity

Study Design

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Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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gp160 MN/LAI-2

Intervention Type BIOLOGICAL

ALVAC-HIV MN120TMG (vCP205)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Jerome H. Kim

Role: PRINCIPAL_INVESTIGATOR

Locations

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Walter Reed Army Institute of Research

Rockville, Maryland, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

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.

Reference Type DERIVED

PMID: 26908741 (View on PubMed)

Other Identifiers

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RV124

Identifier Type: -

Identifier Source: org_study_id