Please use this identifier to cite or link to this item:
https://www.arca.fiocruz.br/handle/icict/62620
Type
ArticleCopyright
Open access
Sustainable Development Goals
03 Saúde e Bem-EstarCollections
Metadata
Show full item record
TEN-YEAR FOLLOW-UP OF 9-VALENT HUMAN PAPILLOMAVIRUS VACCINE: IMMUNOGENICITY, EFFECTIVENESS, AND SAFETY
Vacina contra papilomavírus
Imunogenicidade
Eficácia
Segurança
Author
Restrepo, Jaime
Herrera, Teobaldo
Samakoses, Rudiwilai
Reina, Júlio C.
Pitisuttithum, Punnee
Ulied, Angels
Bekker, Linda-Gail
Moreira Jr, 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
Herrera, Teobaldo
Samakoses, Rudiwilai
Reina, Júlio C.
Pitisuttithum, Punnee
Ulied, Angels
Bekker, Linda-Gail
Moreira Jr, 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
Affilliation
Foundation Clinical Research Center CIC. Medellín, Colombia.
Instituto de Investigatión Nutricional. Lima, Peru.
Department of Pediatrics. Phramongkutklao Hospital. Bangkok, Thailand.
Department of Pediatrics. Universidad del Valle and Centro Médico Imbanaco. Cali, Colombia.
Vaccine Trial Centre. Faculty of Tropical Medicine. Mahidol University. Bangkok, Thailand.
Pediatrics Department. EBA Centelles. Centelles, Spain.
Desmond Tutu HIV Centre. University of Cape Town. Cape Town, South Africa.
Ministério da Saúde. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil.
Karolinska Institute at Danderyd Hospital. Stockholm, Sweden.
Kentucky Pediatric and Adult Research Inc, Bardstown, Kentucky.
Hospital Moinhos de Vento. Porto Alegre, Brasil.
Hospital Pérola Byington. São Paulo, Brasil.
Department of Pathology. McGill University. Montreal, Quebec, Canada.
Department of Gynecology and Obstetrics and Department of Pathology. Johns Hopkins University. Baltimore, Maryland.
Department of Gynecology and Obstetrics and Department of Pathology. Johns Hopkins University. Baltimore, Maryland.
Department of Pathology. University of Virginia. Charlottesville, Virginia.
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Instituto de Investigatión Nutricional. Lima, Peru.
Department of Pediatrics. Phramongkutklao Hospital. Bangkok, Thailand.
Department of Pediatrics. Universidad del Valle and Centro Médico Imbanaco. Cali, Colombia.
Vaccine Trial Centre. Faculty of Tropical Medicine. Mahidol University. Bangkok, Thailand.
Pediatrics Department. EBA Centelles. Centelles, Spain.
Desmond Tutu HIV Centre. University of Cape Town. Cape Town, South Africa.
Ministério da Saúde. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil.
Karolinska Institute at Danderyd Hospital. Stockholm, Sweden.
Kentucky Pediatric and Adult Research Inc, Bardstown, Kentucky.
Hospital Moinhos de Vento. Porto Alegre, Brasil.
Hospital Pérola Byington. São Paulo, Brasil.
Department of Pathology. McGill University. Montreal, Quebec, Canada.
Department of Gynecology and Obstetrics and Department of Pathology. Johns Hopkins University. Baltimore, Maryland.
Department of Gynecology and Obstetrics and Department of Pathology. Johns Hopkins University. Baltimore, Maryland.
Department of Pathology. University of Virginia. Charlottesville, Virginia.
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Merck and Co, Inc. Rahway, New Jersey
Abstract
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.
Keywords in Portuguese
Vacina humana 9-valenteVacina contra papilomavírus
Imunogenicidade
Eficácia
Segurança
Share