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Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.
Restrepo, Jaime; Herrera, Teobaldo; Samakoses, Rudiwilai; Reina, Julio C; Pitisuttithum, Punnee; Ulied, Angels; Bekker, Linda-Gail; Moreira, Edson D; Olsson, Sven-Eric; Block, Stan L; Hammes, Luciano S; Laginha, Fabio; Ferenczy, Alex; Kurman, Robert; Ronnett, Brigitte M; Stoler, Mark; Bautista, Oliver; Gallagher, Nancy E; Salituro, Gino; Ye, Min; Luxembourg, Alain.
Afiliação
  • Restrepo J; Foundation Clinical Research Center CIC, Medellín, Colombia.
  • Herrera T; Instituto de Investigatión Nutricional, Lima, Peru.
  • Samakoses R; Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
  • Reina JC; Department of Pediatrics, Universidad del Valle and Centro Médico Imbanaco, Cali, Colombia.
  • Pitisuttithum P; Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
  • Ulied A; Pediatrics Department, EBA Centelles, Centelles, Spain.
  • Bekker LG; Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
  • Moreira ED; Associação Obras Sociais Irmã Dulce and Gonçalo Moniz Research Center, Oswaldo Cruz Foundation, Ministry of Health, Salvador, BA, Brazil.
  • Olsson SE; Karolinska Institute at Danderyd Hospital, Stockholm, Sweden.
  • Block SL; Kentucky Pediatric and Adult Research Inc, Bardstown, Kentucky.
  • Hammes LS; Hospital Moinhos de Vento, Porto Alegre, Brazil.
  • Laginha F; Hospital Pérola Byington, São Paulo, Brazil.
  • Ferenczy A; Department of Pathology, McGill University, Montreal, Quebec, Canada.
  • Kurman R; Department of Gynecology and Obstetrics and Department of Pathology, Johns Hopkins University, Baltimore, Maryland.
  • Ronnett BM; Department of Gynecology and Obstetrics and Department of Pathology, Johns Hopkins University, Baltimore, Maryland.
  • Stoler M; Department of Pathology, University of Virginia, Charlottesville, Virginia.
  • Bautista O; Merck and Co, Inc., Rahway, New Jersey.
  • Gallagher NE; Merck and Co, Inc., Rahway, New Jersey.
  • Salituro G; Merck and Co, Inc., Rahway, New Jersey.
  • Ye M; Merck and Co, Inc., Rahway, New Jersey.
  • Luxembourg A; Merck and Co, Inc., Rahway, New Jersey.
Pediatrics ; 152(4)2023 Oct 01.
Article em En | MEDLINE | ID: mdl-37667847
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.

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Pediatrics Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Colômbia País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Pediatrics Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Colômbia País de publicação: Estados Unidos