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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Study Completion Date: June 2009
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: II Biological: ALVAC-HIV vCP1521 + AIDSVAX

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

Prime/Boost Vaccination

Placebo Comparator: I 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Thailand
Ban Lamung District Hospital
Ban Lamung District, Chon Buri, Thailand
Phan Tong District Hospital
Phan Tong District, Chon Buri, Thailand, 20160
Sattahip District Hospital
Sattahip District, Chon Buri, Thailand, 20180
Ao Udom Hospital
Sri Racha District, Chon Buri, Thailand, 20230
Ban Chang District Hospital
Ban Chang District, Rayong, Thailand
Ban Khai District Hospital
Ban Khai District, Rayong, Thailand
Klaeng District Hospital
Klaeng District, Rayong, Thailand
Provincial Health Office
Muang District, Rayong, Thailand, 21000
Sponsors and Collaborators
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
Investigators
Principal Investigator: Supachai Rerks-Ngarm, MD Ministry of Health, Thailand
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00223080     History of Changes
Other Study ID Numbers: RV144, HSRRB A-11048
Study First Received: September 13, 2005
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014