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

dc.creatorOlsson, Sven Eric
dc.creatorRestrepo, Jaime Alberto
dc.creatorReina, Julio Cesar
dc.creatorPitisuttithum, Punnee
dc.creatorUlied, Angels
dc.creatorVarman, Meera
dc.creatorVan Damme, Pierre
dc.creatorMoreira Junior, Edson Duarte
dc.creatorFerris, Daron
dc.creatorBlock, Stanley
dc.creatorBautista, Oliver
dc.creatorGallagher, Nancy
dc.creatorMcCauley, Jennifer
dc.creatorLuxembourg, Alain
dc.date2021-01-15T12:28:22Z
dc.date2021-01-15T12:28:22Z
dc.date2020
dc.date.accessioned2023-09-26T20:42:53Z
dc.date.available2023-09-26T20:42:53Z
dc.identifierOLSSON, Sven Eric et al. 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. Papillomavirus Research, v. 10, p. 1-11, 2020.
dc.identifier2405-8521
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/45708
dc.identifier10.1016/j.pvr.2020.100203
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8862538
dc.descriptionMedical writing support, under the direction of the authors, was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in accordance with Good Publication Practice (GPP3) guidelines.
dc.descriptionBackground: 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 ¼ 1272 [females, n ¼ 971; males, n ¼ 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: Geometric mean titers for each 9vHPV vaccine HPV type peaked around month 7 and gradually decreased through month 90. Seropositivity rates remained >90% through month 90 for each of the 9vHPV vaccine types by HPV immunoglobulin Luminex Immunoassay. No cases of HPV6/11/16/18/31/33/45/52/58- related high-grade intraepithelial neoplasia or genital warts were observed in the per-protocol population (n ¼ 1107) based on a maximum follow-up of 8.2 years (median 7.6 years) post-Dose 3. Incidence rates of HPV6/11/ 16/18/31/33/45/52/58-related 6-month persistent infection in females and males were 49.2 and 37.3 per 10,000 person-years, respectively, which were within ranges expected in vaccinated cohorts. There were no vaccine-related SAEs or deaths during the period covered by this interim analysis. Conclusions: The 9vHPV vaccine provided sustained immunogenicity and durable effectiveness through approximately 7 and 8 years, respectively, following vaccination of girls and boys aged 9–15 years.
dc.formatapplication/pdf
dc.languageeng
dc.publisherElsevier
dc.rightsopen access
dc.subjectPapilomavírus humano
dc.subjectImunogenicidade da Vacina
dc.subjectAcompanhamento
dc.subjectVacina
dc.subjectNine-valent human papillomavirus vaccine
dc.subjectEffectiveness Immunogenicity
dc.subjectLong-term follow-up
dc.subjectVaccine
dc.titleLong-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
dc.typeArticle


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