| Author | Goldstone, Stephen E | |
| Author | Giuliano, Anna R | |
| Author | Palefsky, Joel M | |
| Author | Ponce, Eduardo Lazcano | |
| Author | Penny, Mary E | |
| Author | Cabello, Robinson E | |
| Author | Moreira Junior, Edson Duarte | |
| Author | Baraldi, Ezio | |
| Author | Jessen, Heiko | |
| Author | Ferenczy, Alex | |
| Author | Kurman, Robert | |
| Author | Ronnett, Brigitte M | |
| Author | Stoler, Mark H | |
| Author | Bautista, Oliver | |
| Author | Das, Rituparna | |
| Author | Group, Thomas | |
| Author | Luxembourg, Alain | |
| Author | Zhou, Hao Jin | |
| Author | Saah, Alfred | |
| Access date | 2021-12-20T17:23:17Z | |
| Available date | 2021-12-20T17:23:17Z | |
| Document date | 2021 | |
| Citation | 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. | pt_BR |
| ISSN | 1473-3099 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/50488 | |
| 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) | pt_BR |
| Sponsorship | Merck Sharp & Dohme. | pt_BR |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | Vacinação | pt_BR |
| Subject in Portuguese | Doenças Sexualmente Transmissíveis | pt_BR |
| Subject in Portuguese | Homens | pt_BR |
| Subject in Portuguese | Verrugas | pt_BR |
| 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 | pt_BR |
| Type | Article | pt_BR |
| Abstract | 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. | pt_BR |
| Affilliation | "Múltipla ver em Notas" | pt_BR |
| Subject | Vaccination | pt_BR |
| Subject | Sexually Transmitted Diseases | pt_BR |
| Subject | Men | pt_BR |
| Subject | Warts | pt_BR |
| e-ISSN | 10.1016/ S1473-3099(21)00327-3 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
