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| 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. |
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| 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. |
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| 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 |
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| MEDLINE PMIDs | 15272397, 15752839, 15379068 | ||||
| Links | Click here for more information about this study: Phase 3 HIV Vaccine Trial in Thai Adults ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 16402 | ||||
| Start Date † | October 2003 | ||||
| Completion Date | June 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| Investigators † |
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| 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 | ||||