| Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. | |
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MedLine Citation:
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PMID: 19843557 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The development of a safe and effective vaccine against the human immunodeficiency virus type 1 (HIV-1) is critical to pandemic control. METHODS: In a community-based, randomized, multicenter, double-blind, placebo-controlled efficacy trial, we evaluated four priming injections of a recombinant canarypox vector vaccine (ALVAC-HIV [vCP1521]) plus two booster injections of a recombinant glycoprotein 120 subunit vaccine (AIDSVAX B/E). The vaccine and placebo injections were administered to 16,402 healthy men and women between the ages of 18 and 30 years in Rayong and Chon Buri provinces in Thailand. The volunteers, primarily at heterosexual risk for HIV infection, were monitored for the coprimary end points: HIV-1 infection and early HIV-1 viremia, at the end of the 6-month vaccination series and every 6 months thereafter for 3 years. RESULTS: In the intention-to-treat analysis involving 16,402 subjects, there was a trend toward the prevention of HIV-1 infection among the vaccine recipients, with a vaccine efficacy of 26.4% (95% confidence interval [CI], -4.0 to 47.9; P=0.08). In the per-protocol analysis involving 12,542 subjects, the vaccine efficacy was 26.2% (95% CI, -13.3 to 51.9; P=0.16). In the modified intention-to-treat analysis involving 16,395 subjects (with the exclusion of 7 subjects who were found to have had HIV-1 infection at baseline), the vaccine efficacy was 31.2% (95% CI, 1.1 to 52.1; P=0.04). Vaccination did not affect the degree of viremia or the CD4+ T-cell count in subjects in whom HIV-1 infection was subsequently diagnosed. CONCLUSIONS: This ALVAC-HIV and AIDSVAX B/E vaccine regimen may reduce the risk of HIV infection in a community-based population with largely heterosexual risk. Vaccination did not affect the viral load or CD4+ count in subjects with HIV infection. Although the results show only a modest benefit, they offer insight for future research. (ClinicalTrials.gov number, NCT00223080.) |
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Authors:
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Supachai Rerks-Ngarm; Punnee Pitisuttithum; Sorachai Nitayaphan; Jaranit Kaewkungwal; Joseph Chiu; Robert Paris; Nakorn Premsri; Chawetsan Namwat; Mark de Souza; Elizabeth Adams; Michael Benenson; Sanjay Gurunathan; Jim Tartaglia; John G McNeil; Donald P Francis; Donald Stablein; Deborah L Birx; Supamit Chunsuttiwat; Chirasak Khamboonruang; Prasert Thongcharoen; Merlin L Robb; Nelson L Michael; Prayura Kunasol; Jerome H Kim; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S. Date: 2009-10-20 |
Journal Detail:
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Title: The New England journal of medicine Volume: 361 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2009 Dec |
Date Detail:
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Created Date: 2009-12-03 Completed Date: 2009-12-17 Revised Date: 2010-06-21 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 2209-20 Citation Subset: AIM; IM |
Copyright Information:
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2009 Massachusetts Medical Society |
Affiliation:
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Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00223080 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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AIDS Vaccines*
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adverse effects,
immunology Adult CD4 Lymphocyte Count Double-Blind Method Female Follow-Up Studies HIV Antibodies / blood HIV Envelope Protein gp120 / immunology HIV Infections / epidemiology, immunology, prevention & control* HIV-1* / immunology Humans Kaplan-Meiers Estimate Male Proportional Hazards Models Thailand Treatment Outcome Viral Load Young Adult |
| Grant Support | |
ID/Acronym/Agency:
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Y1-AI-2642-12/AI/NIAID NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/AIDS Vaccines; 0/AIDSVAX; 0/HIV Antibodies; 0/HIV Envelope Protein gp120 |
| Investigator | |
Investigator/Affiliation:
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S Rerks-Ngarm / ; S Chunsuttiwat / ; N Premsri / ; C Namwat / ; P Kunasol / ; P Thongcharoen / ; C Khamboonruang / ; P Pitisuttithum / ; V Bussaratid / ; W Maek-a-nantawat / ; J Dhitavat / ; P Suntharasamai / ; S Pungpak / ; S Vanijanonta / ; J Kaewkunwal / ; A Khamsiriwatchara / ; P Jarujareet / ; S Nitayaphan / ; C Easmila / ; S Tabprasit / ; J Chiu / ; R Paris / ; M Benenson / ; A Brown / ; P Morgan / ; M de Souza / ; R Trichavaroj / ; A Schuetz / ; N Thaitawat / ; S Gurunathan / ; J Tartaglia / ; J G McNeil / ; R Harkness / ; C Meric / ; R El Habib / ; L Baglyos / ; D Francis / ; C Lee / ; E Adams / ; J H Kim / ; M L Robb / ; N L Michael / ; M Milazzo / ; A Bolen / ; B Wessner / ; S R Kim / ; M Marovich / ; J Currier / ; D L Birx / ; D Stablein / ; T Germanson / ; L Dally / ; R Wiley / ; J-L Excler / ; J Berenberg / |
| Comments/Corrections | |
Comment In:
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N Engl J Med. 2009 Dec 3;361(23):2279-80
[PMID:
19843556
]
Rev Chilena Infectol. 2010 Apr;27(2):175 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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