Clinical trial NCT00004579: A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
name: Jerome H. Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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)
citation: 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.