Safety and Reactogenicity of Canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E Vaccination in an Efficacy Trial in Thailand
Rattachement africain : th, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: A prime-boost vaccination regimen with ALVAC-HIV (vCP1521) administered intramuscularly at 0, 4, 12, and 24 weeks and gp120 AIDSVAX B/E at 12 and 24 weeks demonstrated modest efficacy of 31.2% for prevention of HIV acquisition in HIV-uninfected adults participating in a community-based efficacy trial in Thailand. METHODOLOGY/PRINCIPAL FINDINGS: Reactogenicity was recorded for 3 days following vaccination. Adverse events were monitored every 6 months for 3.5 years, during which pregnancy outcomes were recorded. Of the 16,402 volunteers, 69% of the participants reported an adverse event any time after the first dose. Only 32.9% experienced an AE within 30 days following any vaccination. Overall adverse event rates and attribution of relatedness did not differ between groups. The frequency of serious adverse events was similar in vaccine (14.3%) and placebo (14.9%) recipients (p = 0.33). None of the 160 deaths (85 in vaccine and 75 in placebo recipients, p = 0.43) was assessed as related to vaccine. The most common cause of death was trauma or traffic accident. Approximately 30% of female participants reported a pregnancy during the study. Abnormal pregnancy outcomes were experienced in 17.1% of vaccine and 14.6% (p = 0.13) of placebo recipients. When the conception occurred within 3 months (estimated) of a vaccination, the majority of these abnormal outcomes were spontaneous or elective abortions among 22.2% and 15.3% of vaccine and placebo pregnant recipients, respectively (p = 0.08). Local reactions occurred in 88.0% of vaccine and 61.0% of placebo recipients (p<0.001) and were more frequent after ALVAC-HIV than AIDSVAX B/E vaccination. Systemic reactions were more frequent in vaccine than placebo recipients (77.2% vs. 59.8%, p<0.001). Local and systemic reactions were mostly mild to moderate, resolving within 3 days. CONCLUSIONS/SIGNIFICANCE: The ALVAC-HIV and AIDSVAX B/E vaccine regimen was found to be safe, well tolerated and suitable for potential large-scale use in Thailand. TRIAL REGISTRATION: ClinicalTrials.govNCT00223080.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Safety and Reactogenicity of Canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E Vaccination in an Efficacy Trial in Thailand
- Date Crossref
- 21/12/2011
- Éditeur
- Public Library of Science (PLoS)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Mahidol University pays non établi dans la noticeUniversité ou école supérieure
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Mahidol Oxford Tropical Medicine Research Unit pays non établi dans la noticeStructure de recherche
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Ministry of Public Health Department of Disease Control pays non établi dans la noticeOrganisme public
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Armed Forces Research Institute of Medical Science pays non établi dans la noticeOrganisation à but non lucratif
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Walter Reed Army Institute of Research U.S. Military HIV Research Program pays non établi dans la noticeOrganisme public
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Tripler Army Medical Center Department of Medicine pays non établi dans la noticeÉtablissement de santé
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Sanofi (United States) pays non établi dans la noticeEntreprise
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Global Solutions for Infectious Diseases pays non établi dans la noticeOrganisation à but non lucratif
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National Institutes of Health Division of AIDS pays non établi dans la noticeOrganisme public
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National Institute of Allergy and Infectious Diseases Division of AIDS pays non établi dans la noticeStructure de recherche
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Emmes (United States) pays non établi dans la noticeEntreprise
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Faculty of Tropical Medicine pays non établi dans la noticeUniversité ou école supérieure
Mahidol University, Mahidol Oxford Tropical Medicine Research Unit et Department of Disease Control — Ministry of Public Health, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.