Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine – A combined analysis of five phase III clinical trials

dc.contributor.authorLone K. Petersenen_US
dc.contributor.authorJaime Restrepoen_US
dc.contributor.authorEdson D. Moreiraen_US
dc.contributor.authorOle Erik Iversenen_US
dc.contributor.authorPunnee Pitisuttithumen_US
dc.contributor.authorPierre Van Dammeen_US
dc.contributor.authorElmar A. Jouraen_US
dc.contributor.authorSven Erik Olssonen_US
dc.contributor.authorDaron Ferrisen_US
dc.contributor.authorStan Blocken_US
dc.contributor.authorAnna R. Giulianoen_US
dc.contributor.authorXavier Boschen_US
dc.contributor.authorSophie Pilsen_US
dc.contributor.authorJack Cuzicken_US
dc.contributor.authorSuzanne M. Garlanden_US
dc.contributor.authorWarner Huhen_US
dc.contributor.authorSusanne K. Kjaeren_US
dc.contributor.authorOliver M. Bautistaen_US
dc.contributor.authorDonna Hyatten_US
dc.contributor.authorRoger Maanssonen_US
dc.contributor.authorErin Moelleren_US
dc.contributor.authorHong Qien_US
dc.contributor.authorChristine Robertsen_US
dc.contributor.authorAlain Luxembourgen_US
dc.contributor.otherÂrhus Universitetshospitalen_US
dc.contributor.otherFundación Centro de Investigación Clínica CICen_US
dc.contributor.otherFundacao Oswaldo Cruzen_US
dc.contributor.otherUniversitetet i Bergenen_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherUniversiteit Antwerpenen_US
dc.contributor.otherMedizinische Universitat Wienen_US
dc.contributor.otherKarolinska Instituteten_US
dc.contributor.otherAugusta Universityen_US
dc.contributor.otherKentucky Pediatric and Adult Research Incen_US
dc.contributor.otherMoffitt Cancer Centeren_US
dc.contributor.otherInstitute Catala Oncologiaen_US
dc.contributor.otherBarts and The London School of Medicine and Dentistryen_US
dc.contributor.otherMurdoch Children's Research Instituteen_US
dc.contributor.otherUniversity of Alabamaen_US
dc.contributor.otherKræftens Bekæmpelseen_US
dc.contributor.otherMerck & Co., Inc.en_US
dc.description.abstract© 2017 The Authors Background The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9–15 years of age and young women 16–26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed. Methods Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1. Results GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1. Conclusions 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.en_US
dc.identifier.citationPapillomavirus Research. Vol.3, (2017), 105-115en_US
dc.rightsMahidol Universityen_US
dc.subjectImmunology and Microbiologyen_US
dc.titleImpact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine – A combined analysis of five phase III clinical trialsen_US