Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up

作者：Sven-Eric Olsson, Jaime Alberto Restrepo, Julio C. Reina, Punnee Pitisuttithum, Àngels Ulied, Meera Varman, Pierre Van Damme, Edson Duarte Moreira, Daron Ferris, S. Block, Oliver Bautista, Nancy Gallagher, Jennifer McCauley, Alain Luxembourg · 发表于：Papillomavirus Research · 年份：2020 · DOI：10.1016/j.pvr.2020.100203 · 被引用次数：61 · 研究领域：Cervical Cancer and HPV Research、Head and Neck Cancer Studies、Reproductive tract infections research

BACKGROUND: The nine-valent human papillomavirus (9vHPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The pivotal 36-month Phase III immunogenicity study of 9vHPV vaccine in 9- to 15-year-old girls and boys was extended to assess long-term immunogenicity and effectiveness through approximately 10 years after vaccination. We describe results of an interim analysis based on approximately 8 years of follow-up after vaccination. METHODS: Participants aged 9-15 years who received three doses of 9vHPV vaccine (at day 1, month 2, and month 6) in the base study and consented to follow-up were enrolled in the long-term follow-up study extension (N = 1272 [females, n = 971; males, n = 301]). Serum was collected at months 66 and 90 to assess antibody responses. For effectiveness analysis, genital swabs were collected (to assess HPV DNA by polymerase chain reaction [PCR]) and external genital examination was conducted (to detect external genital lesions) every 6 months starting when the participant reached 16 years of age. Cervical cytology tests were conducted annually when female participants reached 21 years of age; participants with cytological abnormalities were triaged to colposcopy based on a protocol-specified algorithm. External genital and cervical biopsies of abnormal lesions were performed, and histological diagnoses were adjudicated by a pathology panel. Specimens were tested by PCR to detect HPV DNA. RESULTS: Geo...