Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial

Detalhes bibliográficos
Autor(a) principal: Goldstone, Stephen E
Data de Publicação: 2021
Outros Autores: Giuliano, Anna R, Palefsky, Joel M, Ponce, Eduardo Lazcano, Penny, Mary E, Cabello, Robinson E, Moreira Junior, Edson Duarte, Baraldi, Ezio, Jessen, Heiko, Ferenczy, Alex, Kurman, Robert, Ronnett, Brigitte M, Stoler, Mark H, Bautista, Oliver, Das, Rituparna, Group, Thomas, Luxembourg, Alain, Zhou, Hao Jin, Saah, Alfred
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/50488
Resumo: Icahn School of Medicine at Mount Sinai, New York, NY, USA (S E Goldstone MD); Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA (A R Giuliano PhD); Department of Medicine, University of California at San Francisco, CA, USA (J M Palefsky MD); Instituto Nacional de Salud Pública, Santa María Ahuacatitlán, Cuernavaca, México (E Lazcano-Ponce MD); Instituto de Investigación Nutricional, Lima, Peru (M E Penny MD); Asociación Via Libre, Lima, Peru (R E Cabello MD); Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Bahia, Brazil (E D Moreira Jr MD); Trialtech Research Institute, Pretoria, South Africa (E Baraldi MBChB); Praxis Jessen² + Kollegen, Berlin, Germany (H Jessen MD); McGill University Health Center, Montreal, QC, Canada (A Ferenczy MD); Department of Gynecology and Obstetrics and Department of Pathology Johns Hopkins University, Baltimore, MD, USA (R Kurman MD, B M Ronnett MD); Department of Pathology, University of Virginia, Charlottesville, VA, USA (M H Stoler MD); Merck & Co, Kenilworth, NJ, USA (O Bautista PhD, R Das MD, T Group MS, A Luxembourg MD, A Saah MD); MSD China, Beijing, China (H J Zhou PhD); Sun Yatsen University, Guangzhou, China (H J Zhou)
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spelling Goldstone, Stephen EGiuliano, Anna RPalefsky, Joel MPonce, Eduardo LazcanoPenny, Mary ECabello, Robinson EMoreira Junior, Edson DuarteBaraldi, EzioJessen, HeikoFerenczy, AlexKurman, RobertRonnett, Brigitte MStoler, Mark HBautista, OliverDas, RituparnaGroup, ThomasLuxembourg, AlainZhou, Hao JinSaah, Alfred2021-12-20T17:23:17Z2021-12-20T17:23:17Z2021Goldstone, Stephen E. et al. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infectious Disease, 2021.1473-3099https://www.arca.fiocruz.br/handle/icict/5048810.1016/ S1473-3099(21)00327-3Icahn School of Medicine at Mount Sinai, New York, NY, USA (S E Goldstone MD); Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA (A R Giuliano PhD); Department of Medicine, University of California at San Francisco, CA, USA (J M Palefsky MD); Instituto Nacional de Salud Pública, Santa María Ahuacatitlán, Cuernavaca, México (E Lazcano-Ponce MD); Instituto de Investigación Nutricional, Lima, Peru (M E Penny MD); Asociación Via Libre, Lima, Peru (R E Cabello MD); Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Bahia, Brazil (E D Moreira Jr MD); Trialtech Research Institute, Pretoria, South Africa (E Baraldi MBChB); Praxis Jessen² + Kollegen, Berlin, Germany (H Jessen MD); McGill University Health Center, Montreal, QC, Canada (A Ferenczy MD); Department of Gynecology and Obstetrics and Department of Pathology Johns Hopkins University, Baltimore, MD, USA (R Kurman MD, B M Ronnett MD); Department of Pathology, University of Virginia, Charlottesville, VA, USA (M H Stoler MD); Merck & Co, Kenilworth, NJ, USA (O Bautista PhD, R Das MD, T Group MS, A Luxembourg MD, A Saah MD); MSD China, Beijing, China (H J Zhou PhD); Sun Yatsen University, Guangzhou, China (H J Zhou)Merck Sharp & Dohme."Múltipla ver em Notas"The quadrivalent human papillomavirus (HPV) vaccine was shown to prevent infections and lesions related to HPV6, 11, 16, and 18 in a randomised, placebo-controlled study in men aged 16–26 years. We assessed the incidences of external genital warts related to HPV6 or 11, and external genital lesions and anal dysplasia related to HPV6, 11, 16, or 18, over 10 years of follow-up. Methods The 3-year base study was an international, multicentre, double-blind, randomised, placebo-controlled trial done at 71 sites in 18 countries. Eligible participants were heterosexual men (aged 16–23 years) or men who have sex with men (MSM; aged 16–26 years). Men who had clinically detectable anogenital warts or genital lesions at screening that were suggestive of infection with non-HPV sexually transmitted diseases, or who had a history of such findings, were excluded. Eligible participants were randomly assigned (1:1) to receive three doses of either quadrivalent HPV vaccine or placebo on day 1, month 2, and month 6, administered as a 0·5-mL injection into the deltoid muscle. The 7-year, open-label, long-term follow-up extension study was done at 46 centres in 16 countries. Participants who received one or more doses of the quadrivalent HPV vaccine in the base study were eligible for enrolment into the long-term follow-up study (early vaccination group). Placebo recipients were offered the three-dose quadrivalent HPV vaccine at the end of the base study; those who received one or more quadrivalent HPV vaccine doses were eligible for enrolment into the long-term follow-up study (catch-up vaccination group). The primary efficacy endpoints were the incidence of external genital warts related to HPV6 or 11 and the incidence of external genital lesions related to HPV6, 11, 16, or 18 in all participants and the incidence of anal intraepithelial neoplasia (including anal warts and flat lesions) or anal cancer related to HPV6, 11, 16, or 18 in MSM only. The primary efficacy analysis was done in the per-protocol population for the early vaccination group, which included participants who received all three vaccine doses, were seronegative at day 1 and PCR-negative from day 1 through month 7 of the base study for the HPV type being analysed, had no protocol violations that could affect evaluation of vaccine efficacy, and had attended at least one visit during the long-term follow-up study. For the catch-up vaccination group, efficacy was assessed in the modified intention-to-treat population, which included participants who had received at least one vaccine dose, were seronegative and PCR-negative for HPV types analysed from day 1 of the base study to the final follow-up visit before receiving the quadrivalent HPV vaccine, and had at least one long-term follow-up visit. Safety was assessed in all randomised participants who received at least one vaccine dose. This study is registered with ClinicalTrials.gov, NCT00090285.engElsevierVacinaçãoDoenças Sexualmente TransmissíveisHomensVerrugasVaccinationSexually Transmitted DiseasesMenWartsEfficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trialinfo: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/50488/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALGoldstone, Stephen E. Efficacy....pdfGoldstone, Stephen E. 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dc.title.pt_BR.fl_str_mv Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
title Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
spellingShingle Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
Goldstone, Stephen E
Vacinação
Doenças Sexualmente Transmissíveis
Homens
Verrugas
Vaccination
Sexually Transmitted Diseases
Men
Warts
title_short Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
title_full Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
title_fullStr Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
title_full_unstemmed Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
title_sort Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial
author Goldstone, Stephen E
author_facet Goldstone, Stephen E
Giuliano, Anna R
Palefsky, Joel M
Ponce, Eduardo Lazcano
Penny, Mary E
Cabello, Robinson E
Moreira Junior, Edson Duarte
Baraldi, Ezio
Jessen, Heiko
Ferenczy, Alex
Kurman, Robert
Ronnett, Brigitte M
Stoler, Mark H
Bautista, Oliver
Das, Rituparna
Group, Thomas
Luxembourg, Alain
Zhou, Hao Jin
Saah, Alfred
author_role author
author2 Giuliano, Anna R
Palefsky, Joel M
Ponce, Eduardo Lazcano
Penny, Mary E
Cabello, Robinson E
Moreira Junior, Edson Duarte
Baraldi, Ezio
Jessen, Heiko
Ferenczy, Alex
Kurman, Robert
Ronnett, Brigitte M
Stoler, Mark H
Bautista, Oliver
Das, Rituparna
Group, Thomas
Luxembourg, Alain
Zhou, Hao Jin
Saah, Alfred
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Goldstone, Stephen E
Giuliano, Anna R
Palefsky, Joel M
Ponce, Eduardo Lazcano
Penny, Mary E
Cabello, Robinson E
Moreira Junior, Edson Duarte
Baraldi, Ezio
Jessen, Heiko
Ferenczy, Alex
Kurman, Robert
Ronnett, Brigitte M
Stoler, Mark H
Bautista, Oliver
Das, Rituparna
Group, Thomas
Luxembourg, Alain
Zhou, Hao Jin
Saah, Alfred
dc.subject.other.pt_BR.fl_str_mv Vacinação
Doenças Sexualmente Transmissíveis
Homens
Verrugas
topic Vacinação
Doenças Sexualmente Transmissíveis
Homens
Verrugas
Vaccination
Sexually Transmitted Diseases
Men
Warts
dc.subject.en.pt_BR.fl_str_mv Vaccination
Sexually Transmitted Diseases
Men
Warts
description Icahn School of Medicine at Mount Sinai, New York, NY, USA (S E Goldstone MD); Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA (A R Giuliano PhD); Department of Medicine, University of California at San Francisco, CA, USA (J M Palefsky MD); Instituto Nacional de Salud Pública, Santa María Ahuacatitlán, Cuernavaca, México (E Lazcano-Ponce MD); Instituto de Investigación Nutricional, Lima, Peru (M E Penny MD); Asociación Via Libre, Lima, Peru (R E Cabello MD); Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Bahia, Brazil (E D Moreira Jr MD); Trialtech Research Institute, Pretoria, South Africa (E Baraldi MBChB); Praxis Jessen² + Kollegen, Berlin, Germany (H Jessen MD); McGill University Health Center, Montreal, QC, Canada (A Ferenczy MD); Department of Gynecology and Obstetrics and Department of Pathology Johns Hopkins University, Baltimore, MD, USA (R Kurman MD, B M Ronnett MD); Department of Pathology, University of Virginia, Charlottesville, VA, USA (M H Stoler MD); Merck & Co, Kenilworth, NJ, USA (O Bautista PhD, R Das MD, T Group MS, A Luxembourg MD, A Saah MD); MSD China, Beijing, China (H J Zhou PhD); Sun Yatsen University, Guangzhou, China (H J Zhou)
publishDate 2021
dc.date.accessioned.fl_str_mv 2021-12-20T17:23:17Z
dc.date.available.fl_str_mv 2021-12-20T17:23:17Z
dc.date.issued.fl_str_mv 2021
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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dc.identifier.citation.fl_str_mv Goldstone, Stephen E. et al. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infectious Disease, 2021.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/50488
dc.identifier.issn.pt_BR.fl_str_mv 1473-3099
dc.identifier.eissn.none.fl_str_mv 10.1016/ S1473-3099(21)00327-3
identifier_str_mv Goldstone, Stephen E. et al. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infectious Disease, 2021.
1473-3099
10.1016/ S1473-3099(21)00327-3
url https://www.arca.fiocruz.br/handle/icict/50488
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dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
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