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Sponsor: | U.S. Army Office of the Surgeon General |
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Collaborators: | United States Army Medical Materiel Development Activity 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 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: | U.S. Army Medical Research and Materiel Command |
ClinicalTrials.gov Identifier: | NCT00223080 |
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 |
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HIV Infection |
Biological: ALVAC-HIV vCP1521 + AIDSVAX Biological: ALVAC Placebo + AIDSVAX Placebo |
Phase III |
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 |
Enrollment: | 16402 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | June 2009 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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II: Active Comparator
Intervention: Biological: ALVAC-HIV vCP1521 + AIDSVAX
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Biological: ALVAC-HIV vCP1521 + AIDSVAX
1cc injected into left deltoid muscle at day 0,weeks 4, 12, 24 Prime/Boost Vaccination |
I: Placebo Comparator
Intervention: Biological: ALVAC Placebo + AIDSVAX Placebo
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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 |
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.
Ages Eligible for Study: | 18 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Supachai Rerks-Ngarm, MD | Thai Ministry of Public Health |
Responsible Party: | Robert E. Miller, PhD, RAC, Director, DRAC, U.S. Army Medical Materiel Development Activity |
ClinicalTrials.gov Identifier: | NCT00223080 History of Changes |
Other Study ID Numbers: | RV144, MRMC Log #11048 |
Study First Received: | September 13, 2005 |
Last Updated: | March 21, 2011 |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity |
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 |