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

医学 免疫原性 免疫分析 抗体 入射(几何) 接种疫苗 免疫学 内科学 物理 光学
作者
Juan Carlos Restrepo Restrepo,Teobaldo Herrera,Rudiwilai Samakoses,John H. Reina,Punnee Pitisuttithum,Àngels Ulied,Linda‐Gail Bekker,Edson Duarte Moreira,Sven‐Eric Olsson,Stan L. Block,Luciano Serpa Hammes,Fábio Martins Laginha,Alex Ferenczy,Robert J. Kurman,Brigitte M. Ronnett,Mark H. Stoler,Oliver Bautista,Nancy Gallagher,Gino Salituro,Min Ye,Alain Luxembourg
出处
期刊:Pediatrics [American Academy of Pediatrics]
卷期号:152 (4) 被引量:4
标识
DOI:10.1542/peds.2022-060993
摘要

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.
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