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CompletedNCT00004579Updated Jun 24, 2005

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

A Phase 1 interventional study of gp160 MN/LAI-2 and ALVAC-HIV MN120TMG (vCP205) in HIV Infections and HIV Seronegativity, sponsored by Walter Reed Army Institute of Research (WRAIR). Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Walter Reed Army Institute of Research (WRAIR) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections
  • HIV Seronegativity

Keywords

  • Vaccines, Synthetic
  • Viral Vaccines
  • HIV-1
  • Dose-Response Relationship, Drug
  • HIV Envelope Protein gp160
  • AIDS Vaccines
  • HIV Seronegativity
  • Avipoxvirus
  • Immunization
  • HIV Envelope Protein gp120
  • Recombination, Genetic
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Walter Reed Army Institute of Research (WRAIR) is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Masking
Double

Interventions

  • Biologicalgp160 MN/LAI-2
  • BiologicalALVAC-HIV MN120TMG (vCP205)
06

Study locations

1 site
  • Walter Reed Army Institute of Research
    Rockville, Maryland, United States
07

References and documents

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)
  • 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. PubMed 26908741 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00004579
Lead sponsor
Walter Reed Army Institute of Research (WRAIR)
First posted
Aug 31, 2001
Start date
Apr 1998
Last update
Jun 24, 2005

Study contacts

Jerome H. Kim
principal investigator
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2003. You cannot join it, but the record below documents what was studied.

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