Rationale and design of a double-blind randomized non-inferiority clinical trial to evaluate one or two doses of vaccine against human papillomavirus including an epidemiologic survey to estimate vaccine efficacy: The Costa Rica ESCUDDO trial
Rattachement africain : cr, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
HPV vaccination of adolescent girls is the most effective measure to prevent cervical cancer. The World Health Organization recommends that adolescent girls receive two doses of vaccine but only a small proportion of girls from regions with the highest disease burden are vaccinated because of cost and logistical considerations. Our Costa Rica HPV Vaccine trial suggested that one dose of the bivalent HPV vaccine provides robust and lasting protection against persistent HPV infections for over a decade. Data from a post-licensure trial of the quadrivalent vaccine in India also suggested that a single dose may be effective in reducing cervical cancer risk. To formally compare one versus two doses of the bivalent and nonavalent HPV vaccines, we implemented a large, randomized, double-blind trial to investigate the non-inferiority of one compared to two vaccine doses in the prevention of new HPV16/18 infections that persist 6 or more months. Bivalent and nonavalent vaccines will be evaluated separately. The trial enrolled and randomized (1:1:1:1 to 1- and 2-dose arms of the bivalent and nonavalent vaccines) 20,330 girls 12 to 16 years old residing in Costa Rica. Trial participants are followed every 6 months for up to 5 years. We also aim to estimate vaccine efficacy by comparing the rates of 6 month persistent infection in unvaccinated women with the rates in the follow-up visits of trial participants. We included one survey of unvaccinated women at the start of the study (N = 4452) and will include another survey concomitant with follow up visits of trial participants at year 4.5 (planned N = 3000). Survey participants attend two visits 6 months appart. Herein, we present the rationale, design, and enrolled study population of the ESCUDDO trial. ClinicalTrials.gov Identifier: NCT03180034.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Rationale and design of a double-blind randomized non-inferiority clinical trial to evaluate one or two doses of vaccine against human papillomavirus including an epidemiologic survey to estimate vaccine efficacy: The Costa Rica ESCUDDO trial
- Date Crossref
- 01/01/2022
- Éditeur
- Elsevier BV
- 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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Instituto Costarricense de Investigación y Enseñanza en Nutrición y Salud pays non établi dans la noticeInstitution
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National Institutes of Health pays non établi dans la noticeOrganisme public
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National Cancer Institute Division of Cancer Epidemiology and Genetics pays non établi dans la noticeOrganisme public
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Information Management Services pays non établi dans la noticeEntreprise
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Center for Cancer Research pays non établi dans la noticeStructure de recherche
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Leidos (United States) pays non établi dans la noticeEntreprise
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Frederick National Laboratory for Cancer Research pays non établi dans la noticeStructure de recherche
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Westat (United States) pays non établi dans la noticeEntreprise
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Leidos Biomedical Research Inc. (United States) pays non établi dans la noticeEntreprise
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Department of Health and Human Services pays non établi dans la noticeOrganisme public
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Agencia Costarricense de Investigaciones Biomédicas (ACIB)-Fundación INCIENSA pays non établi dans la noticeEntreprise
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Laboratory of Cellular Oncology pays non établi dans la noticeStructure de recherche
Instituto Costarricense de Investigación y Enseñanza en Nutrición y Salud, National Institutes of Health et Division of Cancer Epidemiology and Genetics — National Cancer Institute, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.