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| 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 |
| 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 |
| 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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| 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 |
| 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 
  |
| 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 |
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