HIV Vaccine Trial in Thai Adults

This study has been completed.
Sponsor:
Collaborators:
United States Army Medical Materiel Development Activity
Armed Forces Research Institute of Medical Sciences, Thailand
Walter Reed Army Institute of Research (WRAIR)
Sanofi Pasteur MSD
VaxGen
The EMMES Corporation
Ministry of Health, Thailand
Mahidol University
Royal Thai Army Medical Department
Tripler Army Medical Center
Henry M Jackson Foundation
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00223080
First received: September 13, 2005
Last updated: September 4, 2012
Last verified: September 2012

September 13, 2005
September 4, 2012
October 2003
July 2006   (final data collection date for primary outcome measure)
HIV infection, assessed every 6 months for 3 years [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
HIV infection, assessed every 6 months for 3 years
Complete list of historical versions of study NCT00223080 on ClinicalTrials.gov Archive Site
Not Provided
HIV viral load and CD4 counts after infection which occur during the 3 year follow-up period
Not Provided
Not Provided
 
HIV Vaccine Trial in Thai Adults
A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults

The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.

A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts to control the HIV pandemic. In this phase III efficacy trial, a 'prime-boost' vaccine strategy is evaluated for prevention of infection and ameliorationn of disease course. ALVAC-HIV (vCP1521) from sanofi pasteur is given as the 'prime' vaccine at months 0, 1, 3 and 6; AIDSVAX gp120 B/E from VaxGen is given as the 'boost' at months 3 and 6. This regimen will be given to 8,000 adult Thai subjects, while another 8,000 will be given placebos in a double-blinded, randomized manner. Following the completion of each subjects immunization phase, he/she will be followed for 3 years with clinic visits every 6 months with HIV testing, pre- and post-test counseling. Subjects who become HIV infected will be counseled, referred to HIV treatment facilities for management according to national guidelines, and offered enrollment in a protocol for extended follow-up.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
HIV Infection
  • Biological: ALVAC-HIV vCP1521 + AIDSVAX

    1cc injected into left deltoid muscle at day 0,weeks 4, 12, 24

    Prime/Boost Vaccination

  • Biological: ALVAC Placebo + AIDSVAX Placebo

    1cc ALVAC Placebo in left deltoid at day 0 and week 4

    1 cc ALVAC Placebo + AIDSVAX Placebo in left deltoid on weeks 12 and 24

  • Active Comparator: II
    Intervention: Biological: ALVAC-HIV vCP1521 + AIDSVAX
  • Placebo Comparator: I
    Intervention: Biological: ALVAC Placebo + AIDSVAX Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16402
June 2009
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Thai citizen, 18-30 years of age; either gender,
  • Available for participation for 3.5 years,
  • Able to understand study and give written informed consent, Completed enrollment in associated screening protocol

Exclusion Criteria:

  • HIV positive,
  • Participant in previous HIV vaccine trial,
  • Active TB or other systemic disease; immunodeficiency or chronic use of immune modifying therapy,
  • History of anaphylaxis or other serious adverse reactions to vaccines,
  • For women, breast feeding or pregnant (or planning to become pregnant during the first 9 months after enrollment)
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00223080
RV144, HSRRB A-11048
Yes
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
  • United States Army Medical Materiel Development Activity
  • Armed Forces Research Institute of Medical Sciences, Thailand
  • Walter Reed Army Institute of Research (WRAIR)
  • Sanofi Pasteur MSD
  • VaxGen
  • The EMMES Corporation
  • Ministry of Health, Thailand
  • Mahidol University
  • Royal Thai Army Medical Department
  • Tripler Army Medical Center
  • Henry M Jackson Foundation
Principal Investigator: Supachai Rerks-Ngarm, MD Ministry of Health, Thailand
U.S. Army Medical Research and Materiel Command
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP