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Int J Cancer. 2016 Dec 15;139(12):2812-2826. doi: 10.1002/ijc.30391. Epub 2016 Sep 9.

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.

Author information

1
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.
2
Department of Obstetrics and Gynaecology, University of Helsinki, Finland.
3
Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
4
University Federal of Rio Grande do Sul, Hospital de Clínica de Porto Alegre, Brazil.
5
Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico.
6
Department of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan.
7
Family Federation of Finland, Sexual Health Clinic, Helsinki, Finland to VL-Medi Research Center, Helsinki, Finland.
8
Institut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain.
9
Department of Gynecology, Oncology Division-CAISM, State University of Campinas, Campinas, Brazil.
10
Vaccine Trials Group, Telethon Institute for Child Health Research, Sydney, NSW, Australia.
11
Sydney University Discipline of Paediatrics and Child Health, Children's Hospital at Westmead, Sydney, NSW, Australia.
12
Kentucky Pediatric and Adult Research, Bardstown, KY, USA.
13
Makati Medical Centre, University of the Philippines, College of Medicine, Philippine General Hospital, Makati City, Philippines.
14
Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Germany.
15
Department of Gynaecology, University Hospital KU Leuven Gasthuisberg, Leuven, Belgium.
16
Department of Gynecology and Obstetrics, Federal University of Paraná, Infectious Diseases in Gynecology and Obstetrics Sector, Curitiba, Paraná, Brazil.
17
University of the Philippines College of Medicine, Philippine General Hospital, Manila, Philippines.
18
Facharzt für Frauenheilkunde und Geburtshilfe, Hamburg, Germany.
19
San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines.
20
GSK Vaccines, Belgium.
21
School of Public Health, University of Tampere, Finland.
22
GlaxoSmithKline, King of Prussia, PA, USA.

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+.

KEYWORDS:

cervical intraepithelial neoplasia; clinical trial; human papillomavirus vaccine; treatment

PMID:
27541373
PMCID:
PMC5412942
DOI:
10.1002/ijc.30391
[Indexed for MEDLINE]
Free PMC Article

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