ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
HIV Vaccine Trial in Thai Adults

This study is ongoing, but not recruiting participants.
Study NCT00223080.   Last updated on December 18, 2007.   Information provided by U.S. Army Medical Research and Materiel Command

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  HIV Vaccine Trial in Thai Adults
Official Title  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
Brief Summary

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.

Detailed Description

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  HIV infection, assessed every 6 months for 3 years [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  HIV Infection
Intervention  Biological: ALVAC-HIV vCP1521 + AIDSVAX
Biological: ALVAC Placebo + AIDSVAX Placebo
MEDLINE PMIDs 15272397,   15752839,   15379068
Links Click here for more information about this study: Phase 3 HIV Vaccine Trial in Thai Adults This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  16402
Start Date  October 2003
Completion Date June 2009
Eligibility Criteria 

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)
Gender Both
Ages 18 Years to 30 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Thailand
Administrative Information Fields
NCT ID  NCT00223080
Organization ID RV144
Secondary IDs †† MRMC Log #11048
Study Sponsor  U.S. Army Medical Research and Materiel Command
Collaborators †† Armed Forces Research Institute of Medical Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
sanofi pasteur
VaxGen
EMMES Corp.
Ministry of Health, Thailand
Mahidol University
Royal Thai Army Medical Department
Tripler Army Medical Center
Henry M Jackson Foundation
Investigators 
Principal Investigator:     Supachai Rerks-Ngarm, MD     Thai Ministry of Public Health    
Information Provided By U.S. Army Medical Research and Materiel Command
Verification Date December 2007
First Received Date  September 13, 2005
Last Updated Date December 18, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers