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Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial - 04/01/12

Doi : 10.1016/S1470-2045(11)70287-X 
Cosette M Wheeler, Dr, ProfPhD a, ⁎ , Xavier Castellsagué, PhD b, Suzanne M Garland, ProfFRCPA c, Anne Szarewski, PhD d, Jorma Paavonen, ProfMD e, Paulo Naud, ProfPhD f, Jorge Salmerón, ProfPhD g, Song-Nan Chow, ProfMD h, Dan Apter, MD i, Henry Kitchener, ProfMD j, Júlio C Teixeira, MD k, S Rachel Skinner, PhD l, Unnop Jaisamrarn, ProfMD m, Genara Limson, ProfMD n, Barbara Romanowski, ProfMD o, Fred Y Aoki, ProfMD p, Tino F Schwarz, ProfMD q, Willy A J Poppe, ProfPhD r, F Xavier Bosch, PhD b, Diane M Harper, MD s, Warner Huh, MD t, Karin Hardt, PhD u, Toufik Zahaf, PhD u, Dominique Descamps, MD u, Frank Struyf, MD u, Gary Dubin, MD v, Matti Lehtinen, ProfPhD w

for the HPV PATRICIA Study Group‡

  For the HPV PATRICIA Study Group see Supplementary Material

a Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA 
b Unit of Infections and Cancer, Cancer Epidemiology Research Program, Institut Català d’Oncologia, L’Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain 
c Department of Microbiology and Infectious Diseases, Royal Women’s Hospital, Department of Microbiology, Royal Children’s Hospital, Murdoch Children’s Research Institute, and Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, Australia 
d Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK 
e Department of Obstetrics and Gynaecology, University of Helsinki, Helsinki, Finland 
f Department of Gynecology and Obstetrics, Federal University of Rio Grande do Sul, UFRGS/HCPA, Hospital de Clínicas de Porto Alegre, Brazil 
g Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico 
h Department of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan 
i Family Federation of Finland, Sexual Health Clinic, Helsinki, Finland 
j Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation Trust, St Mary’s Hospital, Manchester, UK 
k Departamento de Tocoginecologia da Unicamp, University of Campinas, Campinas, Brazil 
l Vaccines Trials Group, Telethon Institute for Child Health Research, Perth, WA, and Sydney University Discipline of Paediatrics and Child Health, Children’s Hospital Westmead, Sydney, NSW, Australia 
m Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand 
n College of Medicine, University of the Philippines, Philippine General Hospital, Makati Medical Centre, Makati City, Philippines 
o Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada 
p Department of Medical Microbiology, University of Manitoba, Winnipeg, MB, Canada 
q Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Wuerzburg, Germany 
r Department of Gynaecology, University Hospital KU Leuven Gasthuisberg, Leuven, Belgium 
s Dartmouth Medical School, Hanover, NH, USA 
t Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL, USA 
u GlaxoSmithKline Biologicals, Wavre, Belgium 
v GlaxoSmithKline Biologicals, King of Prussia, PA, USA 
w University of Tampere, School of Public Health, Tampere, Finland 

* Correspondence to: Dr Cosette M Wheeler, Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA

Summary

Background

We evaluated the efficacy of the human papillomavirus HPV-16/18 AS04-adjuvanted vaccine against non-vaccine oncogenic HPV types in the end-of-study analysis after 4 years of follow-up in PATRICIA (PApilloma TRIal against Cancer In young Adults).

Methods

Healthy women aged 15–25 years with no more than six lifetime sexual partners were included in PATRICIA irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to HPV-16/18 vaccine or a control hepatitis A vaccine, via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites. The study was double-blind. The primary endpoint of PATRICIA has been reported previously; the present analysis evaluates cross-protective vaccine efficacy against non-vaccine oncogenic HPV types in the end-of-study analysis. Analyses were done for three cohorts: the according-to-protocol cohort for efficacy (ATP-E; vaccine n=8067, control n=8047), total vaccinated HPV-naive cohort (TVC-naive; no evidence of infection with 14 oncogenic HPV types at baseline, approximating young adolescents before sexual debut; vaccine n=5824, control n=5820), and the total vaccinated cohort (TVC; all women who received at least one vaccine dose, approximating catch-up populations that include sexually active women; vaccine n=9319, control=9325). Vaccine efficacy was evaluated against 6-month persistent infection, cervical intraepithelial neoplasia grade 2 or greater (CIN2+) associated with 12 non-vaccine HPV types (individually or as composite endpoints), and CIN3+ associated with the composite of 12 non-vaccine HPV types. This study is registered with ClinicalTrials.gov, number NCT00122681.

Findings

Consistent vaccine efficacy against persistent infection and CIN2+ (with or without HPV-16/18 co-infection) was seen across cohorts for HPV-33, HPV-31, HPV-45, and HPV-51. In the most conservative analysis of vaccine efficacy against CIN2+, where all cases co-infected with HPV-16/18 were removed, vaccine efficacy was noted for HPV-33 in all cohorts, and for HPV-31 in the ATP-E and TVC-naive. Vaccine efficacy against CIN2+ associated with the composite of 12 non-vaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), with or without HPV-16/18 co-infection, was 46·8% (95% CI 30·7–59·4) in the ATP-E, 56·2% (37·2–69·9) in the TVC-naive, and 34·2% (20·4–45·8) in the TVC. Corresponding values for CIN3+ were 73·8% (48·3–87·9), 91·4% (65·0–99·0), and 47·5% (22·8–64·8).

Interpretation

Data from the end-of-study analysis of PATRICIA show cross-protective efficacy of the HPV-16/18 vaccine against four oncogenic non-vaccine HPV types—HPV-33, HPV-31, HPV-45, and HPV-51—in different trial cohorts representing diverse groups of women.

Funding

GlaxoSmithKline Biologicals.

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Vol 13 - N° 1

P. 100-110 - janvier 2012 Retour au numéro
Article précédent Article précédent
  • Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial
  • Matti Lehtinen, Jorma Paavonen, Cosette M Wheeler, Unnop Jaisamrarn, Suzanne M Garland, Xavier Castellsagué, S Rachel Skinner, Dan Apter, Paulo Naud, Jorge Salmerón, Song-Nan Chow, Henry Kitchener, Júlio C Teixeira, James Hedrick, Genara Limson, Anne Szarewski, Barbara Romanowski, Fred Y Aoki, Tino F Schwarz, Willy A J Poppe, Newton S De Carvalho, Maria Julieta V Germar, Klaus Peters, Adrian Mindel, Philippe De Sutter, F Xavier Bosch, Marie-Pierre David, Dominique Descamps, Frank Struyf, Gary Dubin, for the HPV PATRICIA Study Group ‡
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