TY - JOUR
T1 - Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine
T2 - Immunogenicity, Effectiveness, and Safety
AU - Restrepo, Jaime
AU - Herrera, Teobaldo
AU - Samakoses, Rudiwilai
AU - Reina, Julio C.
AU - Pitisuttithum, Punnee
AU - Ulied, Angels
AU - Bekker, Linda Gail
AU - Moreira, Edson D.
AU - Olsson, Sven Eric
AU - Block, Stan L.
AU - Hammes, Luciano S.
AU - Laginha, Fabio
AU - Ferenczy, Alex
AU - Kurman, Robert
AU - Ronnett, Brigitte M.
AU - Stoler, Mark
AU - Bautista, Oliver
AU - Gallagher, Nancy E.
AU - Salituro, Gino
AU - Ye, Min
AU - Luxembourg, Alain
N1 - Publisher Copyright:
© 2023 by the American Academy of Pediatrics.
PY - 2023/10/1
Y1 - 2023/10/1
N2 - 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.
AB - 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.
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U2 - 10.1542/PEDS.2022-060993
DO - 10.1542/PEDS.2022-060993
M3 - Article
C2 - 37667847
AN - SCOPUS:85171418160
SN - 0031-4005
VL - 152
JO - Pediatrics
JF - Pediatrics
IS - 4
M1 - e2022060993
ER -