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RESEARCH PRODUCT

Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27–45 years of age compared to women 16–26 years of age: An open-label phase 3 study

Klaus PetersJalid SehouliAngels UliedKyeongmi CheonElmar A. JouraPhilippe TummersOlaf ReichPekka NieminenJuan José Hernandez AguadoPierre Van DammeTanja FehmFrancesco RaspagliesiFrederick WittkeAlain LuxembourgGabriel Fiol RuizMassimo OrigoniAntonino PerinoSonali RawatCorinne VandermeulenMerce Peris TuserLinn WoelberIlkka SeppaMilagrosa Rua FigueroaSara BruckerMiia VirtaWiebren A.a. TjalmaAnitta Ahonen

subject

AdultHuman papillomavirusmedicine.medical_specialtyAdolescentAntibodies ViralYoung Adult03 medical and health sciencesNine-valent human papillomavirus vaccineImmunogenicity Vaccine0302 clinical medicine030225 pediatricsInternal medicinemedicineHumansPapillomavirus Vaccines030212 general & internal medicineSeroconversionHPV prophylaxisAdverse effectAgedCervical cancerHuman papillomavirus 16Human papillomavirus 18General VeterinaryGeneral Immunology and Microbiologybusiness.industryPapillomavirus InfectionsAdult vaccinationPublic Health Environmental and Occupational Healthmedicine.diseaseVaccine efficacyConfidence interval3. Good healthVaccinationClinical trialPrecancerRegimenInfectious DiseasesCervical cancerMolecular MedicineFemaleHuman medicinebusiness

description

Abstract: Background: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16 & ndash;26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27 & ndash;45 versus 16 & ndash;26 years of age. Methods: This international, open-label study (NCT03158220) was conducted in women 16 & ndash;45 years of age. Participants (16 & ndash;26 years, n = 570 and 27 & ndash;45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study. Results: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27 & ndash;45 years were compared to those in women 16 & ndash;26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27 & ndash;45 years to 16 & ndash;26 years) was 0.60 & ndash;0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27 & ndash; 45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16 & ndash;26 years, and 85.2% and 24.1% of women 27 & ndash; 45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study. Conclusions: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27 & ndash;45 years compared with women 16 & ndash;26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16 & ndash;26 years to women 27 & ndash;45 years of age. Clinical trial registration NCT03158220. (c) 2021 Elsevier Ltd. All rights reserved.

yearjournalcountryeditionlanguage
2021-01-01Vaccine
https://doi.org/10.1016/j.vaccine.2021.01.074