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• W3207130661 endingPage "106592" @default.
• W3207130661 startingPage "106592" @default.
• W3207130661 abstract "Seven high-risk human papillomavirus (HPV) types (16/18/31/33/45/52/58) covered by the 9-valent HPV (9vHPV) vaccine cause >90% of HPV-related head and neck cancers (HNCs). An ongoing clinical trial (NCT04199689) was designed to evaluate 9vHPV vaccine efficacy against HPV oral persistent infection, a surrogate endpoint for HPV-related HNCs.In this double-blind, placebo-controlled, international trial, men aged 20-45 years (N = 6000) are randomized 1:1 to receive 9vHPV vaccine or placebo on day 1, month 2, and month 6. The primary objective is to demonstrate whether 9vHPV vaccination reduces incidence of HPV16/18/31/33/45/52/58-related 6-month oral persistent infection. Incidence of HPV6/11-related 6-month oral persistent infection will be evaluated as a secondary endpoint. Oral rinse and gargle samples will be collected on day 1, month 7, month 12, and every 6 months thereafter for HPV detection by PCR. Primary analyses will be performed in per-protocol populations. Efficacy in this case-driven study will be analyzed upon accrual of ≥20 primary efficacy endpoint cases. Serum will be collected at day 1 and months 7, 12, 24, 36, and 42; anti-HPV antibody titers will be measured by competitive Luminex immunoassay. Data will be summarized as geometric mean titers and seropositivity rates. Injection-site and systemic adverse events (AEs) will be collected for 15 days post-any vaccination and serious AEs through 6 months after the last vaccination; deaths and vaccine-related serious AEs will be collected throughout the study.This trial is expected to generate important data regarding the potential for 9vHPV vaccine to prevent HPV-related head and neck disease." @default.
• W3207130661 created "2021-10-25" @default.
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• W3207130661 date "2022-04-01" @default.
• W3207130661 modified "2023-10-03" @default.
• W3207130661 title "Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men" @default.
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• W3207130661 doi "https://doi.org/10.1016/j.cct.2021.106592" @default.
• W3207130661 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/34678491" @default.
• W3207130661 hasPublicationYear "2022" @default.
• W3207130661 type Work @default.

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