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

NCT00004579 | Completed Phase 1

• 1 other identifier: RV124
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Interventions

gp160 MN/LAI-2 BIOLOGICAL

ALVAC-HIV MN120TMG (vCP205) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead

Study Sites (1)

Walter Reed Army Institute of Research

Rockville, Maryland, United States

Location

Related Publications (2)

• 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)

  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.

  PMID: 26908741 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jerome H. Kim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: FED

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: April 1, 1998
• Last Updated: June 24, 2005

Record last verified: 2003-06

Locations

US (1)