Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety
Issued Date
2023-10-01
Resource Type
ISSN
00314005
eISSN
10984275
Scopus ID
2-s2.0-85171418160
Pubmed ID
37667847
Journal Title
Pediatrics
Volume
152
Issue
4
Rights Holder(s)
SCOPUS
Bibliographic Citation
Pediatrics Vol.152 No.4 (2023)
Suggested Citation
Restrepo J., Herrera T., Samakoses R., Reina J.C., Pitisuttithum P., Ulied A., Bekker L.G., Moreira E.D., Olsson S.E., Block S.L., Hammes L.S., Laginha F., Ferenczy A., Kurman R., Ronnett B.M., Stoler M., Bautista O., Gallagher N.E., Salituro G., Ye M., Luxembourg A. Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety. Pediatrics Vol.152 No.4 (2023). doi:10.1542/PEDS.2022-060993 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/90881
Title
Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety
Author's Affiliation
Faculty of Tropical Medicine, Mahidol University
School of Medicine
Hospital Moinhos de Vento
Universidad del Valle, Cali
University of Virginia School of Medicine
Danderyds Sjukhus
Fundacao Oswaldo Cruz
Merck & Co., Inc.
Kentucky Pediatric/Adult Research
Phramongkutklao College of Medicine
Johns Hopkins University
University of Cape Town
Instituto de Investigati on Nutricional
EBA Centelles
Foundation Clinical Research Center CIC
Hospital Pérola Byington
School of Medicine
Hospital Moinhos de Vento
Universidad del Valle, Cali
University of Virginia School of Medicine
Danderyds Sjukhus
Fundacao Oswaldo Cruz
Merck & Co., Inc.
Kentucky Pediatric/Adult Research
Phramongkutklao College of Medicine
Johns Hopkins University
University of Cape Town
Instituto de Investigati on Nutricional
EBA Centelles
Foundation Clinical Research Center CIC
Hospital Pérola Byington
Other Contributor(s)
Abstract
BACKGROUND AND OBJECTIVES: The 9-valent human papillomavirus (9vHPV) vaccine Phase III immu-nogenicity 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 5 301) and girls (n 5 971) 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 in-traepithelial 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 Ȉ10 years post 3 doses of 9vHPV vaccination of boys and girls aged 9 to 15 years.