| Author | Restrepo, Jaime | |
| Author | Herrera, Teobaldo | |
| Author | Samakoses, Rudiwilai | |
| Author | Reina, Júlio C. | |
| Author | Pitisuttithum, Punnee | |
| Author | Ulied, Angels | |
| Author | Bekker, Linda-Gail | |
| Author | Moreira Jr, Edson D. | |
| Author | Olsson, Sven-Eric | |
| Author | Block, Stan L. | |
| Author | Hammes, Luciano S. | |
| Author | Laginha, Fabio | |
| Author | Ferenczy, Alex | |
| Author | Kurman, Robert | |
| Author | Ronnett, Brigitte M. | |
| Author | Stoler, Mark | |
| Author | Bautista, Oliver | |
| Author | Gallagher, Nancy E. | |
| Author | Salituro, Gino | |
| Author | Ye, Min | |
| Author | Luxembourg, Alain | |
| Access date | 2024-02-08T19:13:11Z | |
| Available date | 2024-02-08T19:13:11Z | |
| Document date | 2023 | |
| Citation | RESTREPO, Jaime et al. Ten-year follow-up of 9-valent human papillomavirus vaccine: immunogenicity, effectiveness, and safety. Pediatrics, v. 152, n. 4, p. 1-13, 2023. | en_US |
| ISSN | 1098-4275 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/62620 | |
| Sponsorship | Merck Sharp and Dohme LLC. | en_US |
| Language | eng | en_US |
| Publisher | American Academy of Pediatrics | en_US |
| Rights | open access | en_US |
| Subject in Portuguese | Vacina humana 9-valente | en_US |
| Subject in Portuguese | Vacina contra papilomavírus | en_US |
| Subject in Portuguese | Imunogenicidade | en_US |
| Subject in Portuguese | Eficácia | en_US |
| Subject in Portuguese | Segurança | en_US |
| Title | Ten-year follow-up of 9-valent human papillomavirus vaccine: immunogenicity, effectiveness, and safety | en_US |
| Type | Article | en_US |
| DOI | 10.1542/peds.2022-060993 | |
| 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. | en_US |
| Affilliation | Foundation Clinical Research Center CIC. Medellín, Colombia. | en_US |
| Affilliation | Instituto de Investigatión Nutricional. Lima, Peru. | en_US |
| Affilliation | Department of Pediatrics. Phramongkutklao Hospital. Bangkok, Thailand. | en_US |
| Affilliation | Department of Pediatrics. Universidad del Valle and Centro Médico Imbanaco. Cali, Colombia. | en_US |
| Affilliation | Vaccine Trial Centre. Faculty of Tropical Medicine. Mahidol University. Bangkok, Thailand. | en_US |
| Affilliation | Pediatrics Department. EBA Centelles. Centelles, Spain. | en_US |
| Affilliation | Desmond Tutu HIV Centre. University of Cape Town. Cape Town, South Africa. | en_US |
| Affilliation | Ministério da Saúde. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil. | en_US |
| Affilliation | Karolinska Institute at Danderyd Hospital. Stockholm, Sweden. | en_US |
| Affilliation | Kentucky Pediatric and Adult Research Inc, Bardstown, Kentucky. | en_US |
| Affilliation | Hospital Moinhos de Vento. Porto Alegre, Brasil. | en_US |
| Affilliation | Hospital Pérola Byington. São Paulo, Brasil. | en_US |
| Affilliation | Department of Pathology. McGill University. Montreal, Quebec, Canada. | en_US |
| Affilliation | Department of Gynecology and Obstetrics and Department of Pathology. Johns Hopkins University. Baltimore, Maryland. | en_US |
| Affilliation | Department of Gynecology and Obstetrics and Department of Pathology. Johns Hopkins University. Baltimore, Maryland. | en_US |
| Affilliation | Department of Pathology. University of Virginia. Charlottesville, Virginia. | en_US |
| Affilliation | Merck and Co, Inc. Rahway, New Jersey | en_US |
| Affilliation | Merck and Co, Inc. Rahway, New Jersey | en_US |
| Affilliation | Merck and Co, Inc. Rahway, New Jersey | en_US |
| Affilliation | Merck and Co, Inc. Rahway, New Jersey | en_US |
| Affilliation | Merck and Co, Inc. Rahway, New Jersey | en_US |
| Subject | 9-valent human vaccine | en_US |
| Subject | Papillomavirus vaccine | en_US |
| Subject | Immunogenicity | en_US |
| Subject | Effectiveness | en_US |
| Subject | Safety | en_US |
| DeCS | Vacinas Combinadas | en_US |
| DeCS | Vacinas contra Papillomavirus | en_US |
| DeCS | Imunogenicidade da Vacina | en_US |
| DeCS | Eficácia | en_US |
| DeCS | Segurança | en_US |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
