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Clin Vaccine Immunol. 2015 Apr;22(4):361-73. doi: 10.1128/CVI.00591-14. Epub 2015 Feb 4.

Efficacy of human papillomavirus 16 and 18 (HPV-16/18) AS04-adjuvanted vaccine against cervical infection and precancer in young women: final event-driven analysis of the randomized, double-blind PATRICIA trial.

Collaborators (162)

Denham I, Garland S, Mindel A, O'Sullivan M, Skinner S, Naud P, Teixeira J, De Sutter P, Poppe W, Aoki F, Orr P, Diaz-Mitoma F, Dionne M, Ferguson L, Miller M, Orr P, Papp K, Ramjattan B, Romanowski B, Somani R, Apter D, Karppa T, Kudjoi N, Kupari M, Lehtinen M, Niemi L, Paavonen J, Palmroth J, Petaja T, Romppanen U, Salmivesi S, Siitari-Mattila M, Svartsjo S, Tuomivaara L, Belling K, Gent T, Gieseking F, Grubert T, Harlfinger W, Hopker W, Jensen-El Tobgui S, Peters K, Schoenian S, Schulze K, Schwarz T, Liverani C, Mojana G, Salmeron J, Benitez G, Crisostomo C, Del Rosario-Raymundo R, Germar M, Limson G, Raymundo J, Remollino M, Villanueva G, Villanueva S, Zamora J, Zamora L, Bajo J, Bayas J, Campins M, Castellsague X, Castro M, Centeno C, Rodriguez L, Torne A, Vidart J, Chow S, Yu M, Yuan C, Chu T-, Angsuwathana S, Jaisamrarn U, Wilawan K, Abdulhakim E, Cruickshank M, Govindraj S, Kitchener H, Lewis D, Pavel I, Pawa R, Szarewski A, Ackerman R, Ault K, Bennett N, Caldwell M, Chambers C, Chatterjee A, Demars L, De Santis T, Downs L, Ferris D, Fine P, Harper D, Hedrick J, Herzig W, Huh W, Hutchinson C, Kamemoto L, Klein T, Klugman K, Koltun W, Kong A, Lalezari J, Lee P, Leeman L, Luber S, Martens M, Peterson C, Pitts K, Rosen J, Rosenfeld W, Scutella M, Seidman L, Sperling M, Stager M, Stapleton J, Swenson K, Thoming C, Twiggs L, Tyring S, Waldbaum A, Wheeler C, Zbella E, Kiviat N, Klugman K, Nieminen P, Bergeron C, Eisenstein E, Marks R, Nolan T, Tay S, Albers S, Bollaerts P, Camier A, Colau B, De Breyne A, Genevrois S, Martens N, Peeters P, Smoes N, Spiessens B, Tavares F, Meurée A, Houard N, Tonglet A, Vanden-Dunghen S, Vilain A, Ward K, Alt E, Iskaros B, Limaye A, Liu-Jarin X, Luff R, McNeeley M, Provenzano C, Molijn A, Quint W, Struijk L, Van de Sandt M, Van Doorn L.

Author information

1
Family Federation of Finland, Sexual Health Clinic, Helsinki, Finland dan.apter@vaestoliitto.fi.
2
Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.
3
Department of Obstetrics and Gynaecology, University of Helsinki, Helsinki, Finland.
4
Cancer Epidemiology Research Program, Institut Català d'Oncologia (ICO), IDIBELL, Biomedical Research Centre Network for Epidemiology and Public Health (CIBER-ESP), L'Hospitalet de Llobregat, Catalonia, Spain.
5
Microbiology and Infectious Diseases Department, Royal Women's Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.
6
Vaccine Trials Group, Telethon Institute for Child Health Research, Perth, Western Australia, and Sydney University Discipline of Paediatrics and Child Health, Children's Hospital at Westmead, Sydney, New South Wales, Australia.
7
University Federal of Rio Grande do Sul, Hospital de Clínica de Porto Alegre, Porto Alegre, Brazil.
8
Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico.
9
Department of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan.
10
Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation Trust, St Mary's Hospital, Manchester, United Kingdom.
11
University of Campinas, Campinas, Brazil.
12
Chulalongkorn University, Department of Obstetrics and Gynaecology, Faculty of Medicine, Bangkok, Thailand.
13
University of the Philippines, College of Medicine, Philippine General Hospital, Makati Medical Centre, Makati City, Philippines.
14
Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
15
University of Alberta, Edmonton, Alberta, Canada.
16
University of Manitoba, Winnipeg, Manitoba, Canada.
17
Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Wuerzburg, Germany.
18
Department of Gynaecology, University Hospital KU Leuven Gasthuisberg, Leuven, Belgium.
19
Cancer Epidemiology Research Program, Institut Català d'Oncologia (ICO), IDIBELL, Network on Cooperative Cancer Research (RTICC), L'Hospitalet de Llobregat, Catalonia, Spain.
20
Centre for AIDS Programme of Research in South Africa, Durban, South Africa.
21
Afdelingshoofd Gynaecologie-Oncologie, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
22
GSK Vaccines, Wavre, Belgium.
23
University of Tampere, School of Public Health, Tampere, Finland.
24
GSK Vaccines, King of Prussia, Pennsylvania, USA.

Abstract

We report final event-driven analysis data on the immunogenicity and efficacy of the human papillomavirus 16 and 18 ((HPV-16/18) AS04-adjuvanted vaccine in young women aged 15 to 25 years from the PApilloma TRIal against Cancer In young Adults (PATRICIA). The total vaccinated cohort (TVC) included all randomized participants who received at least one vaccine dose (vaccine, n = 9,319; control, n = 9,325) at months 0, 1, and/or 6. The TVC-naive (vaccine, n = 5,822; control, n = 5,819) had no evidence of high-risk HPV infection at baseline, approximating adolescent girls targeted by most HPV vaccination programs. Mean follow-up was approximately 39 months after the first vaccine dose in each cohort. At baseline, 26% of women in the TVC had evidence of past and/or current HPV-16/18 infection. HPV-16 and HPV-18 antibody titers postvaccination tended to be higher among 15- to 17-year-olds than among 18- to 25-year-olds. In the TVC, vaccine efficacy (VE) against cervical intraepithelial neoplasia grade 1 or greater (CIN1+), CIN2+, and CIN3+ associated with HPV-16/18 was 55.5% (96.1% confidence interval [CI], 43.2, 65.3), 52.8% (37.5, 64.7), and 33.6% (-1.1, 56.9). VE against CIN1+, CIN2+, and CIN3+ irrespective of HPV DNA was 21.7% (10.7, 31.4), 30.4% (16.4, 42.1), and 33.4% (9.1, 51.5) and was consistently significant only in 15- to 17-year-old women (27.4% [10.8, 40.9], 41.8% [22.3, 56.7], and 55.8% [19.2, 76.9]). In the TVC-naive, VE against CIN1+, CIN2+, and CIN3+ associated with HPV-16/18 was 96.5% (89.0, 99.4), 98.4% (90.4, 100), and 100% (64.7, 100), and irrespective of HPV DNA it was 50.1% (35.9, 61.4), 70.2% (54.7, 80.9), and 87.0% (54.9, 97.7). VE against 12-month persistent infection with HPV-16/18 was 89.9% (84.0, 94.0), and that against HPV-31/33/45/51 was 49.0% (34.7, 60.3). In conclusion, vaccinating adolescents before sexual debut has a substantial impact on the overall incidence of high-grade cervical abnormalities, and catch-up vaccination up to 18 years of age is most likely effective. (This study has been registered at ClinicalTrials.gov under registration no. NCT001226810.).

PMID:
25651922
PMCID:
PMC4375348
DOI:
10.1128/CVI.00591-14
[Indexed for MEDLINE]
Free PMC Article

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