title: Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial.
abstract: We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+.
authors.affiliation: Microbiology and Infectious Diseases Department, Royal Women's Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia. suzanne.garland@thewomens.org.au.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.affiliation: Department of Obstetrics and Gynaecology, University of Helsinki, Finland.
authors.forename: Jorma
authors.initials: J
authors.lastname: Paavonen
authors.affiliation: Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
authors.forename: Unnop
authors.initials: U
authors.lastname: Jaisamrarn
authors.affiliation: University Federal of Rio Grande do Sul, Hospital de Clínica de Porto Alegre, Brazil.
authors.forename: Paulo
authors.initials: P
authors.lastname: Naud
authors.affiliation: Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico.
authors.forename: Jorge
authors.initials: J
authors.lastname: Salmerón
authors.affiliation: Department of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan.
authors.forename: Song-Nan
authors.initials: SN
authors.lastname: Chow
authors.affiliation: Family Federation of Finland, Sexual Health Clinic, Helsinki, Finland to VL-Medi Research Center, Helsinki, Finland.
authors.forename: Dan
authors.initials: D
authors.lastname: Apter
authors.affiliation: Institut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Castellsagué
authors.affiliation: Department of Gynecology, Oncology Division-CAISM, State University of Campinas, Campinas, Brazil.
authors.forename: Júlio C
authors.initials: JC
authors.lastname: Teixeira
authors.affiliation: Vaccine Trials Group, Telethon Institute for Child Health Research, Sydney, NSW, Australia.|Sydney University Discipline of Paediatrics and Child Health, Children's Hospital at Westmead, Sydney, NSW, Australia.
authors.forename: S Rachel
authors.initials: SR
authors.lastname: Skinner
authors.affiliation: Kentucky Pediatric and Adult Research, Bardstown, KY, USA.
authors.forename: James
authors.initials: J
authors.lastname: Hedrick
authors.affiliation: Makati Medical Centre, University of the Philippines, College of Medicine, Philippine General Hospital, Makati City, Philippines.
authors.forename: Genara
authors.initials: G
authors.lastname: Limson
authors.affiliation: Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Germany.
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.affiliation: Department of Gynaecology, University Hospital KU Leuven Gasthuisberg, Leuven, Belgium.
authors.forename: Willy A J
authors.initials: WA
authors.lastname: Poppe
authors.affiliation: Institut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain.
authors.forename: F Xavier
authors.initials: FX
authors.lastname: Bosch
authors.affiliation: Department of Gynecology and Obstetrics, Federal University of Paraná, Infectious Diseases in Gynecology and Obstetrics Sector, Curitiba, Paraná, Brazil.
authors.forename: Newton S
authors.initials: NS
authors.lastname: de Carvalho
authors.affiliation: University of the Philippines College of Medicine, Philippine General Hospital, Manila, Philippines.
authors.forename: Maria Julieta V
authors.initials: MJ
authors.lastname: Germar
authors.affiliation: Facharzt für Frauenheilkunde und Geburtshilfe, Hamburg, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Peters
authors.affiliation: San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines.
authors.forename: M Rowena
authors.initials: MR
authors.lastname: Del Rosario-Raymundo
authors.affiliation: GSK Vaccines, Belgium.
authors.forename: Grégory
authors.initials: G
authors.lastname: Catteau
authors.affiliation: GSK Vaccines, Belgium.
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
authors.affiliation: GSK Vaccines, Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Struyf
authors.affiliation: School of Public Health, University of Tampere, Finland.
authors.forename: Matti
authors.initials: M
authors.lastname: Lehtinen
authors.affiliation: GlaxoSmithKline, King of Prussia, PA, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local; D017063:Outcome Assessment, Health Care; D030361:Papillomavirus Infections / Q000150:complications / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000276:immunology*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D014611:Vaccination; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000209:etiology* / Q000473:pathology* / Q000601:surgery
chemical_list: D000276:Adjuvants, Immunologic; D053918:Papillomavirus Vaccines
keywords: cervical intraepithelial neoplasia; clinical trial; human papillomavirus vaccine; treatment