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HIV Vaccine Trial in Thai Adults

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: U.S. Army Medical Research and Materiel Command
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
Information provided by: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00223080
  Purpose

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.


Condition Intervention Phase
HIV Infection
Biological: ALVAC-HIV vCP1521 + AIDSVAX
Biological: ALVAC Placebo + AIDSVAX Placebo
Phase III

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • HIV infection, assessed every 6 months for 3 years [ Time Frame: 36 Months ] [ Designated as safety issue: No ]

Enrollment:   16402
Study Start Date:   October 2003
Estimated Study Completion Date:   June 2009

Arms Assigned Interventions
II: Active Comparator Biological: ALVAC-HIV vCP1521 + AIDSVAX

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

Prime/Boost Vaccination

I: Placebo Comparator 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


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.

  Eligibility
Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223080

Locations
Thailand, Chon Buri
Phan Tong District Hospital    
      Phan Tong District, Chon Buri, Thailand, 20160
Ao Udom Hospital    
      Sri Racha District, Chon Buri, Thailand, 20230
Ban Lamung District Hospital    
      Ban Lamung District, Chon Buri, Thailand
Sattahip District Hospital    
      Sattahip District, Chon Buri, Thailand, 20180
Thailand, Rayong
Klaeng District Hospital    
      Klaeng District, Rayong, Thailand
Ban Chang District Hospital    
      Ban Chang District, Rayong, Thailand
Ban Khai District Hospital    
      Ban Khai District, Rayong, Thailand
Provincial Health Office    
      Muang District, Rayong, Thailand, 21000

Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
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    
  More Information

Click here for more information about this study: Phase 3 HIV Vaccine Trial in Thai Adults  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   U.S. Army Medical Materiel Development Activity ( U.S. Army Medical Research and Materiel Command )
Study ID Numbers:   RV144, MRMC Log #11048
First Received:   September 13, 2005
Last Updated:   December 18, 2007
ClinicalTrials.gov Identifier:   NCT00223080
Health Authority:   United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
HIV Seronegativity  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 05, 2008




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