Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies
Post 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 (NCT0054...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2425146 |
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| author | Anna R. Giuliano Joel M. Palefsky Stephen E. Goldstone Jacob Bornstein Ilse De Coster Ana María Guevara Ole Mogensen Andrea Schilling Pierre Van Damme Corinne Vandermeulen Misoo C. Ellison Susan Kaplan Jianxin Lin Rachael Bonawitz Alain Luxembourg |
| author_facet | Anna R. Giuliano Joel M. Palefsky Stephen E. Goldstone Jacob Bornstein Ilse De Coster Ana María Guevara Ole Mogensen Andrea Schilling Pierre Van Damme Corinne Vandermeulen Misoo C. Ellison Susan Kaplan Jianxin Lin Rachael Bonawitz Alain Luxembourg |
| author_sort | Anna R. Giuliano |
| collection | DOAJ |
| description | Post 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. |
| format | Article |
| id | doaj-art-4af721d3be6a4913a4a0f051995dcec4 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-4af721d3be6a4913a4a0f051995dcec42025-01-22T13:17:06ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2024.2425146Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studiesAnna R. Giuliano0Joel M. Palefsky1Stephen E. Goldstone2Jacob Bornstein3Ilse De Coster4Ana María Guevara5Ole Mogensen6Andrea Schilling7Pierre Van Damme8Corinne Vandermeulen9Misoo C. Ellison10Susan Kaplan11Jianxin Lin12Rachael Bonawitz13Alain Luxembourg14Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, Tampa, FL, USADepartment of Medicine, University of California at San Francisco, San Francisco, CA, USADepartment of Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USADepartment of Obstetrics and Gynecology, Galilee Medical Center and Azrieli Faculty of Medicine, Bar-Ilan University, Nahariya, IsraelCentre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, BelgiumResearch Unit, Pablo Tobon Uribe Hospital, Medellin, Antioquia, ColombiaDepartment of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, DenmarkClinical Research Center, Institute of Sciences and Innovation in Medicine, Facultad de Medicina Clinica Alemana Universidad del Desarrollo, Santiago, ChileCentre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, BelgiumDepartment of Public Health and Primary Care, Leuven University Vaccinology Center, KU Leuven, Leuven, BelgiumMerck & Co, Inc, Rahway, NJ, USAMerck & Co, Inc, Rahway, NJ, USAMerck & Co, Inc, Rahway, NJ, USAMerck & Co, Inc, Rahway, NJ, USAMerck & Co, Inc, Rahway, NJ, USAPost 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.https://www.tandfonline.com/doi/10.1080/21645515.2024.24251469-valent HPV vaccinehuman papillomavirusimmunogenicitymales |
| spellingShingle | Anna R. Giuliano Joel M. Palefsky Stephen E. Goldstone Jacob Bornstein Ilse De Coster Ana María Guevara Ole Mogensen Andrea Schilling Pierre Van Damme Corinne Vandermeulen Misoo C. Ellison Susan Kaplan Jianxin Lin Rachael Bonawitz Alain Luxembourg Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies Human Vaccines & Immunotherapeutics 9-valent HPV vaccine human papillomavirus immunogenicity males |
| title | Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies |
| title_full | Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies |
| title_fullStr | Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies |
| title_full_unstemmed | Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies |
| title_short | Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies |
| title_sort | immunogenicity of the 9 valent human papillomavirus vaccine post hoc analysis from five phase 3 studies |
| topic | 9-valent HPV vaccine human papillomavirus immunogenicity males |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2425146 |
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