| Author | Olsson, Sven Eric | |
| Author | Restrepo, Jaime Alberto | |
| Author | Reina, Julio Cesar | |
| Author | Pitisuttithum, Punnee | |
| Author | Ulied, Angels | |
| Author | Varman, Meera | |
| Author | Van Damme, Pierre | |
| Author | Moreira Junior, Edson Duarte | |
| Author | Ferris, Daron | |
| Author | Block, Stanley | |
| Author | Bautista, Oliver | |
| Author | Gallagher, Nancy | |
| Author | McCauley, Jennifer | |
| Author | Luxembourg, Alain | |
| Access date | 2021-01-15T12:28:22Z | |
| Available date | 2021-01-15T12:28:22Z | |
| Document date | 2020 | |
| Citation | 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. | pt_BR |
| ISSN | 2405-8521 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/45708 | |
| Sponsorship | 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. | pt_BR |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | Papilomavírus humano | pt_BR |
| Subject in Portuguese | Imunogenicidade da Vacina | pt_BR |
| Subject in Portuguese | Acompanhamento | pt_BR |
| Subject in Portuguese | Vacina | pt_BR |
| 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 | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1016/j.pvr.2020.100203 | |
| Abstract | 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. | pt_BR |
| Affilliation | Karolinska Institute at Danderyd Hospital. Stockholm, Sweden. | pt_BR |
| Affilliation | Foundation Clinical Research Center CIC. Medellín, Colombia. | pt_BR |
| Affilliation | Universidad del Valle and Centro Medico Imbanaco. Department of Pediatrics. Cali, Colombia. | pt_BR |
| Affilliation | Mahidol University. Faculty of Tropical Medicine. Vaccine Trial Centre. Bangkok, Thailand. | pt_BR |
| Affilliation | Pediatrics Department. EBA Centelles. Centelles, Spain. | pt_BR |
| Affilliation | Creighton University. Pediatric Infectious Diseases. Omaha, NE, USA. | pt_BR |
| Affilliation | University of Antwerp. Vaccine & Infectious Disease Institute. Centre for the Evaluation of Vaccination. Antwerp, Belgium. | pt_BR |
| Affilliation | Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Bahia, Brasil. | pt_BR |
| Affilliation | Augusta University. Department of Obstetrics and Gynecology,Augusta. Georgia, USA. | pt_BR |
| Affilliation | Kentucky Pediatric and Adult Research Inc. Bardstown, KY, USA. | pt_BR |
| Affilliation | Merck & Co. Inc. Kenilworth, NJ, USA. | pt_BR |
| Affilliation | Merck & Co. Inc. Kenilworth, NJ, USA. | pt_BR |
| Affilliation | Merck & Co. Inc. Kenilworth, NJ, USA. | pt_BR |
| Affilliation | Merck & Co. Inc. Kenilworth, NJ, USA. | pt_BR |
| Subject | Nine-valent human papillomavirus vaccine | pt_BR |
| Subject | Effectiveness Immunogenicity | pt_BR |
| Subject | Long-term follow-up | pt_BR |
| Subject | Vaccine | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
