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Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies

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dc.contributor.authorGiuliano, Anna
dc.contributor.authorPalefsky, Joel
dc.contributor.authorGoldstone, Stephen
dc.contributor.authorBornsteind, Jacob
dc.contributor.authorDe Coster, Ilse
dc.contributor.authorGuevara, Ana
dc.contributor.authorMogensen, Ole
dc.contributor.authorSchilling Redlich, Andrea
dc.contributor.authorVan Damme, Pierre
dc.contributor.authorVandermeulen, Corinne
dc.contributor.authorEllison, Misoo
dc.contributor.authorThomas Group
dc.contributor.authorKaplan, Susan
dc.contributor.authorLin, Jianxin
dc.contributor.authorBonawitz, Rachael
dc.contributor.authorLuxembourg, Alain
dc.date.accessioned2026-08-11T21:06:21Z
dc.date.available2026-08-11T21:06:21Z
dc.date.issued2025
dc.description.abstractPost hoc analyses of 9-valent human papillomavirus (9vHPV) vaccine immunogenicity were conducted in five Phase 3 studies that enrolled males. Month 7 antibody geometric mean titers (GMTs) after three 9vHPV vaccine doses were analyzed in 10,024 males/females aged 16-26 years from studies 001 (NCT00543543), 002 (NCT00943722), 003 (NCT01651949), and 020 (NCT02114385). Covariates considered were age, gender, sexual orientation, region of residence, and race. GMTs among 2599 males/females aged 9-15 years (studies 002 and 010 [NCT01984697]) were assessed 6 months after one, two, and three 9vHPV vaccine doses. 9vHPV vaccine immunogenicity was robust across populations. Month 7 GMTs were generally higher in participants aged 16-21 versus 22-26 years. Region and race minimally impacted immunogenicity. Adjusted integrated analysis showed lower immunogenicity in men who have sex with men (MSM) versus heterosexual men (HM) for nine HPV types, and higher immunogenicity in HM versus females for seven HPV types. Among 9-15-year-olds, trends toward higher GMTs in males versus females post-Dose 3, similar GMTs post-Dose 2, and lower post-Dose 1 were observed. In conclusion, 9vHPV vaccine immunogenicity was robust in males aged 16-26 years across a range of baseline characteristics. GMT ratios for males versus females aged 9-15 years tended to increase with more doses.
dc.description.versionVersión Aceptada
dc.identifier.citationGiuliano AR, Palefsky JM, Goldstone SE, Bornstein J, De Coster I, Guevara AM, Mogensen O, Schilling A, Van Damme P, Vandermeulen C, Ellison MC; Thomas Group; Kaplan S, Lin J, Bonawitz R, Luxembourg A. Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies. Hum Vaccin Immunother. 2025 Dec;21(1):2425146. doi: 10.1080/21645515.2024.2425146
dc.identifier.doihttps://doi.org/10.1080/21645515.2024.2425146
dc.identifier.urihttps://hdl.handle.net/11447/10998
dc.language.isoen
dc.subject9-valent HPV vaccine
dc.subjecthuman papillomavirus
dc.subjectimmunogenicity
dc.subjectmales
dc.titleImmunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies
dc.typeArticle
dcterms.accessRightsAcceso Abierto
dcterms.sourceHuman vaccines and immunotherapeutics
dspace.entity.typePublication
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relation.isAuthorOfPublication.latestForDiscoveryc4b84d1b-640f-4b15-94a2-03181f398c50

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