Vaccine | 2021
Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45\u202fyears of age compared to women 16-26\u202fyears of age: An open-label phase 3 study.
Abstract
BACKGROUND\nEfficacy 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 16-26\u202fyears of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26\u202fyears of age.\n\n\nMETHODS\nThis international, open-label study (NCT03158220) was conducted in women 16-45\u202fyears of age. Participants (16-26\u202fyears, n\u202f=\u202f570 and 27-45\u202fyears, n\u202f=\u202f642) 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.\n\n\nRESULTS\nAt month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45\u202fyears were compared to those in women 16-26\u202fyears 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 (27-45\u202fyears to 16-26\u202fyears) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45\u202fyears 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 16-26\u202fyears, and 85.2% and 24.1% of women 27-45\u202fyears of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study.\n\n\nCONCLUSIONS\nThe 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45\u202fyears compared with women 16-26\u202fyears 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 16-26\u202fyears to women 27-45\u202fyears of age. Clinical trial registration NCT03158220.