HIV Vaccine Trial in Thai Adults
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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 |
- 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 |
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| 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 | Ministry of Health, Thailand |
More Information
Additional 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 May 21, 2013