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HIV Vaccine Trial in Thai Adults
This study is ongoing, but not recruiting participants.
Study NCT00223080   Information provided by U.S. Army Medical Research and Materiel Command
First Received: September 13, 2005   Last Updated: June 22, 2009   History of Changes

September 13, 2005
June 22, 2009
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
 
HIV viral load and CD4 counts after infection which occur during the 3 year follow-up period
 
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.

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
HIV Infection
  • Biological: ALVAC-HIV vCP1521 + AIDSVAX
  • Biological: ALVAC Placebo + AIDSVAX Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
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
U.S. Army Medical Research and Materiel Command, U.S. Army Medical Materiel Development Activity
RV144, MRMC Log #11048
U.S. Army Medical Research and Materiel Command
  • Armed Forces Research Institute of Medical Sciences, Thailand
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Walter Reed Army Institute of Research (WRAIR)
  • sanofi pasteur
  • 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 Thai Ministry of Public Health
U.S. Army Medical Research and Materiel Command
June 2009

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