Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety

• Published in: Pediatrics (Evanston) 2023-10, Vol.152 (4)
• Main Authors: Restrepo, Jaime, Herrera, Teobaldo, Samakoses, Rudiwilai, Reina, Julio C., Pitisuttithum, Punnee, Ulied, Angels, Bekker, Linda-Gail, Moreira, Edson D., Olsson, Sven-Eric, Block, Stan L., Hammes, Luciano S., Laginha, Fabio, Ferenczy, Alex, Kurman, Robert, Ronnett, Brigitte M., Stoler, Mark, Bautista, Oliver, Gallagher, Nancy E., Salituro, Gino, Ye, Min, Luxembourg, Alain
• Format: Article
• Language: English
• Subjects: Children & youth; Girls; Human papillomavirus; Immunoassay; Immunogenicity; Immunoglobulin G; Pediatrics; Vaccine efficacy; Vaccines
• ISSN: 0031-4005; 1098-4275
• DOI: 10.1542/peds.2022-060993

BACKGROUND AND OBJECTIVES The 9-valent human papillomavirus (9vHPV) vaccine Phase III immunogenicity study in 9- to 15-year-old boys and girls was extended to assess immunogenicity and effectiveness through 10 years after the last vaccine dose (NCT00943722). METHODS Boys (n = 301) and girls (n = 971) who received three 9vHPV vaccine doses in the base study (day 1, months 2 and 6) enrolled in the extension. Serum was collected through month 126 for antibody assessments by competitive Luminex immunoassay and immunoglobulin G-Luminex immunoassay. For effectiveness analysis starting at age 16 years, genital swabs were collected (to assess HPV DNA by polymerase chain reaction) and external genital examinations conducted every 6 months. Primary analyses were conducted in per-protocol populations. RESULTS Geometric mean antibody titers peaked around month 7, decreased sharply between months 7 and 12, then gradually through month 126. Seropositivity rates remained ≥81% by competitive Luminex immunoassay and ≥95% by immunoglobin G-Luminex immunoassay at month 126 for each 9vHPV vaccine type. After up to 11.0 (median 10.0) years of follow-up postdose 3, there were no cases of HPV6/11/16/18/31/33/45/52/58-related high-grade intraepithelial neoplasia or condyloma in males or females. Incidence rates of HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infection in males and females were low (54.6 and 52.4 per 10000 person-years, respectively) and within ranges expected in vaccinated cohorts, based on previous human papillomavirus vaccine efficacy trials. CONCLUSIONS The 9vHPV vaccine demonstrated sustained immunogenicity and effectiveness through ∼10 years post 3 doses of 9vHPV vaccination of boys and girls aged 9 to 15 years.