Quadrivalent HPV Vaccine Evaluation Study with Addition of the Nonavalent Vaccine (QUEST-ADVANCE): protocol of an observational cohort study
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Le résumé fourni par la source
INTRODUCTION: The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE. METHODS AND ANALYSIS: QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1-3 doses of the quadrivalent or nonavalent HPV vaccine at 9-14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9-14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4-5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20-27-year-old females vaccinated at 9-14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16-26 years of age up to 12 years postvaccination. ETHICS AND DISSEMINATION: QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children's and Women's Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Quadrivalent HPV Vaccine Evaluation Study with Addition of the Nonavalent Vaccine (QUEST-ADVANCE): protocol of an observational cohort study
- Date Crossref
- 01/09/2025
- Éditeur
- BMJ
- 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.
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National Institute for Public Health and the Environment Centre for Infectious Disease Control pays non établi dans la noticeStructure de recherche
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Women's Health Research Institute pays non établi dans la noticeStructure de recherche
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BC Children's Hospital pays non établi dans la noticeÉtablissement de santé
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BC Children's Hospital Research Institute pays non établi dans la noticeUniversité ou école supérieure
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BC Cancer Agency Cancer Control Research pays non établi dans la noticeÉtablissement de santé
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BC Centre for Disease Control pays non établi dans la noticeOrganisme public
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University of British Columbia Department of Pediatrics pays non établi dans la noticeUniversité ou école supérieure
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Université Laval pays non établi dans la noticeUniversité ou école supérieure
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St. Michael's Hospital pays non établi dans la noticeÉtablissement de santé
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University of Toronto pays non établi dans la noticeUniversité ou école supérieure
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Unity Health Toronto pays non établi dans la noticeÉtablissement de santé
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Vancouver Coastal Health pays non établi dans la noticeÉtablissement de santé
Centre for Infectious Disease Control — National Institute for Public Health and the Environment, Women's Health Research Institute et BC Children's Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.