Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up

Detalhes bibliográficos
Autor(a) principal: Olsson, Sven Eric
Data de Publicação: 2020
Outros Autores: Restrepo, Jaime Alberto, Reina, Julio Cesar, Pitisuttithum, Punnee, Ulied, Angels, Varman, Meera, Van Damme, Pierre, Moreira Junior, Edson Duarte, Ferris, Daron, Block, Stanley, Bautista, Oliver, Gallagher, Nancy, McCauley, Jennifer, Luxembourg, Alain
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/45708
Resumo: Medical writing support, under the direction of the authors, was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in accordance with Good Publication Practice (GPP3) guidelines.
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spelling Olsson, Sven EricRestrepo, Jaime AlbertoReina, Julio CesarPitisuttithum, PunneeUlied, AngelsVarman, MeeraVan Damme, PierreMoreira Junior, Edson DuarteFerris, DaronBlock, StanleyBautista, OliverGallagher, NancyMcCauley, JenniferLuxembourg, Alain2021-01-15T12:28:22Z2021-01-15T12:28:22Z2020OLSSON, Sven Eric et al. Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up. Papillomavirus Research, v. 10, p. 1-11, 2020.2405-8521https://www.arca.fiocruz.br/handle/icict/4570810.1016/j.pvr.2020.100203Medical writing support, under the direction of the authors, was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in accordance with Good Publication Practice (GPP3) guidelines.Karolinska Institute at Danderyd Hospital. Stockholm, Sweden.Foundation Clinical Research Center CIC. Medellín, Colombia.Universidad del Valle and Centro Medico Imbanaco. Department of Pediatrics. Cali, Colombia.Mahidol University. Faculty of Tropical Medicine. Vaccine Trial Centre. Bangkok, Thailand.Pediatrics Department. EBA Centelles. Centelles, Spain.Creighton University. Pediatric Infectious Diseases. Omaha, NE, USA.University of Antwerp. Vaccine & Infectious Disease Institute. Centre for the Evaluation of Vaccination. Antwerp, Belgium.Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Bahia, Brasil.Augusta University. Department of Obstetrics and Gynecology,Augusta. Georgia, USA.Kentucky Pediatric and Adult Research Inc. Bardstown, KY, USA.Merck & Co. Inc. Kenilworth, NJ, USA.Merck & Co. Inc. Kenilworth, NJ, USA.Merck & Co. Inc. Kenilworth, NJ, USA.Merck & Co. Inc. Kenilworth, NJ, USA.Background: The nine-valent human papillomavirus (9vHPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The pivotal 36-month Phase III immunogenicity study of 9vHPV vaccine in 9- to 15-year-old girls and boys was extended to assess long-term immunogenicity and effectiveness through approximately 10 years after vaccination. We describe results of an interim analysis based on approximately 8 years of follow-up after vaccination. Methods: Participants aged 9–15 years who received three doses of 9vHPV vaccine (at day 1, month 2, and month 6) in the base study and consented to follow-up were enrolled in the long-term follow-up study extension (N ¼ 1272 [females, n ¼ 971; males, n ¼ 301]). Serum was collected at months 66 and 90 to assess antibody responses. For effectiveness analysis, genital swabs were collected (to assess HPV DNA by polymerase chain reaction [PCR]) and external genital examination was conducted (to detect external genital lesions) every 6 months starting when the participant reached 16 years of age. Cervical cytology tests were conducted annually when female participants reached 21 years of age; participants with cytological abnormalities were triaged to colposcopy based on a protocol-specified algorithm. External genital and cervical biopsies of abnormal lesions were performed, and histological diagnoses were adjudicated by a pathology panel. Specimens were tested by PCR to detect HPV DNA. Results: Geometric mean titers for each 9vHPV vaccine HPV type peaked around month 7 and gradually decreased through month 90. Seropositivity rates remained >90% through month 90 for each of the 9vHPV vaccine types by HPV immunoglobulin Luminex Immunoassay. No cases of HPV6/11/16/18/31/33/45/52/58- related high-grade intraepithelial neoplasia or genital warts were observed in the per-protocol population (n ¼ 1107) based on a maximum follow-up of 8.2 years (median 7.6 years) post-Dose 3. Incidence rates of HPV6/11/ 16/18/31/33/45/52/58-related 6-month persistent infection in females and males were 49.2 and 37.3 per 10,000 person-years, respectively, which were within ranges expected in vaccinated cohorts. There were no vaccine-related SAEs or deaths during the period covered by this interim analysis. Conclusions: The 9vHPV vaccine provided sustained immunogenicity and durable effectiveness through approximately 7 and 8 years, respectively, following vaccination of girls and boys aged 9–15 years.engElsevierPapilomavírus humanoImunogenicidade da VacinaAcompanhamentoVacinaNine-valent human papillomavirus vaccineEffectiveness ImmunogenicityLong-term follow-upVaccineLong-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-upinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83097https://www.arca.fiocruz.br/bitstream/icict/45708/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALOlsson, Eric-Sven Long-term immunogenicity....pdfOlsson, Eric-Sven Long-term immunogenicity....pdfapplication/pdf2844152https://www.arca.fiocruz.br/bitstream/icict/45708/2/Olsson%2c%20Eric-Sven%20Long-term%20immunogenicity....pdf1e92e53eb3870a124bd173d21f8d44b6MD52TEXTOlsson, Eric-Sven Long-term immunogenicity....pdf.txtOlsson, Eric-Sven Long-term immunogenicity....pdf.txtExtracted texttext/plain64768https://www.arca.fiocruz.br/bitstream/icict/45708/3/Olsson%2c%20Eric-Sven%20Long-term%20immunogenicity....pdf.txt22280adf3de9f9203959341d69a8672eMD53icict/457082023-03-15 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dc.title.pt_BR.fl_str_mv Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
title Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
spellingShingle Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
Olsson, Sven Eric
Papilomavírus humano
Imunogenicidade da Vacina
Acompanhamento
Vacina
Nine-valent human papillomavirus vaccine
Effectiveness Immunogenicity
Long-term follow-up
Vaccine
title_short Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
title_full Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
title_fullStr Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
title_full_unstemmed Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
title_sort Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up
author Olsson, Sven Eric
author_facet Olsson, Sven Eric
Restrepo, Jaime Alberto
Reina, Julio Cesar
Pitisuttithum, Punnee
Ulied, Angels
Varman, Meera
Van Damme, Pierre
Moreira Junior, Edson Duarte
Ferris, Daron
Block, Stanley
Bautista, Oliver
Gallagher, Nancy
McCauley, Jennifer
Luxembourg, Alain
author_role author
author2 Restrepo, Jaime Alberto
Reina, Julio Cesar
Pitisuttithum, Punnee
Ulied, Angels
Varman, Meera
Van Damme, Pierre
Moreira Junior, Edson Duarte
Ferris, Daron
Block, Stanley
Bautista, Oliver
Gallagher, Nancy
McCauley, Jennifer
Luxembourg, Alain
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Olsson, Sven Eric
Restrepo, Jaime Alberto
Reina, Julio Cesar
Pitisuttithum, Punnee
Ulied, Angels
Varman, Meera
Van Damme, Pierre
Moreira Junior, Edson Duarte
Ferris, Daron
Block, Stanley
Bautista, Oliver
Gallagher, Nancy
McCauley, Jennifer
Luxembourg, Alain
dc.subject.other.pt_BR.fl_str_mv Papilomavírus humano
Imunogenicidade da Vacina
Acompanhamento
Vacina
topic Papilomavírus humano
Imunogenicidade da Vacina
Acompanhamento
Vacina
Nine-valent human papillomavirus vaccine
Effectiveness Immunogenicity
Long-term follow-up
Vaccine
dc.subject.en.pt_BR.fl_str_mv Nine-valent human papillomavirus vaccine
Effectiveness Immunogenicity
Long-term follow-up
Vaccine
description Medical writing support, under the direction of the authors, was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in accordance with Good Publication Practice (GPP3) guidelines.
publishDate 2020
dc.date.issued.fl_str_mv 2020
dc.date.accessioned.fl_str_mv 2021-01-15T12:28:22Z
dc.date.available.fl_str_mv 2021-01-15T12:28:22Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv OLSSON, Sven Eric et al. Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up. Papillomavirus Research, v. 10, p. 1-11, 2020.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/45708
dc.identifier.issn.pt_BR.fl_str_mv 2405-8521
dc.identifier.doi.none.fl_str_mv 10.1016/j.pvr.2020.100203
identifier_str_mv OLSSON, Sven Eric et al. Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up. Papillomavirus Research, v. 10, p. 1-11, 2020.
2405-8521
10.1016/j.pvr.2020.100203
url https://www.arca.fiocruz.br/handle/icict/45708
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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