Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18

A Szarewski; D.M Harper; W.A.J Poppe; S.R Skinner; C.M Wheeler; J Paavonen; P Naud; J Salmeron; D Apter; H Kitchener; X Castellsagué; J.C Teixeira; J Hedrick; U Jaisamrarn; G Limson; S Garland; B Romanowski; F.Y Aoki; T.F Schwarz; F.X Bosch; K Hardt; T Zahaf; D Descamps; F Struyf; M Lehtinen; G Dubin; HPV PATRICIA Study Group

doi:10.1002/ijc.26362

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Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18

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Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18

A Szarewski, D.M Harper, W.A.J Poppe, S.R Skinner, C.M Wheeler, J Paavonen, P Naud, J Salmeron, D Apter, H Kitchener, …

International Journal of Cancer, Vol.7(1), pp.106-116

07/01/2012

DOI: 10.1002/ijc.26362

PMID: 21858807

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Abstract

In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) was highly efficacious against HPV-16/18 infections and precancerous lesions in women HPV-16/18 deoxyribose nucleic acid (DNA) negative and seronegative at baseline. We present further data on vaccine efficacy (VE) against HPV-16/18 in the total vaccinated cohort including women who may have been exposed to HPV-16/18 infection before vaccination. In women with no evidence of current or previous HPV-16/18 infection (DNA negative and seronegative), VE was 90.3% (96.1% confidence interval: 87.3–92.6) against 6-month persistent infection (PI), 91.9% (84.6–96.2) against cervical intraepithelial neoplasia (CIN)1+ and 94.6% (86.3–98.4) against CIN2+ [97.7% (91.1–99.8) when using the HPV type assignment algorithm (TAA)]. In women HPV-16/18 DNA negative but with serological evidence of previous HPV-16/18 infection (seropositive), VE was 72.3% (53.0–84.5) against 6-month PI, 67.2% (10.9–89.9) against CIN1+, and 68.8% (−28.3–95.0) against CIN2+ [88.5% (10.8–99.8) when using TAA]. In women with no evidence of current HPV-16/18 infection (DNA negative), regardless of their baseline HPV-16/18 serological status, VE was 88.7% (85.7–91.1) against 6-month PI, 89.1% (81.6–94.0) against CIN1+ and 92.4% (84.0–97.0) against CIN2+ [97.0% (90.6–99.5) when using TAA]. In women who were DNA positive for one vaccine type, the vaccine was efficacious against the other vaccine type. The vaccine did not impact the outcome of HPV-16/18 infections present at the time of vaccination. Vaccination was generally well tolerated regardless of the woman's HPV-16/18 DNA or serological status at entry.

human papillomavirus-16

vaccine efficacy against human papillomavirus-16/18

previous exposure

human papillomavirus vaccines

human papillomavirus-18

Details

Title: Subtitle: Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18
Creators: A Szarewski - Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK
D.M Harper - Dartmouth Medical School, Lebanon NH
W.A.J Poppe - Department of Gynaecology, University Hospital KU Leuven Gasthuisberg, Leuven, Belgium
S.R Skinner - 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
C.M Wheeler - Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM
J Paavonen - Department of Obstetrics and Gynaecology, University of Helsinki, Helsinki, Finland
P Naud - Department of Gynecology & Obstetrics, Federal University of Rio Grande do Sul - UFRGS/HCPA - Hospital de Clínicas de Porto Alegre, Brazil
J Salmeron - Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico
D Apter - Family Federation of Finland, Sexual Health Clinic, Helsinki, Finland
H Kitchener - Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation Trust, St Mary's Hospital, Manchester, UK
X Castellsagué - Institut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain
J.C Teixeira - Departamento de Tocoginecologia da Unicamp, University of Campinas, Campinas, Sao Paulo, Brazil
J Hedrick - Kentucky Pediatric and Adult Research, Bardstown, KY
U Jaisamrarn - Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
G Limson - College of Medicine, University of the Philippines, Philippine General Hospital, Makati Medical Centre, Makati City, Philippines
S Garland - Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville/Department of Microbiology, The Royal Children's Hospital, Parkville/Murdoch Childrens Research Institute, Parkville/Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia
B Romanowski - Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada
F.Y Aoki - Department of Medical Microbiology, University of Manitoba, Winnipeg, MB, Canada
T.F Schwarz - Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Wuerzburg, Germany
F.X Bosch - Institut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain
K Hardt - GlaxoSmithKline Biologicals, Wavre, Belgium
T Zahaf - GlaxoSmithKline Biologicals, Wavre, Belgium
D Descamps - GlaxoSmithKline Biologicals, Wavre, Belgium
F Struyf - GlaxoSmithKline Biologicals, Wavre, Belgium
M Lehtinen - University of Tampere
G Dubin - GlaxoSmithKline Biologicals, King of Prussia, PA
HPV PATRICIA Study Group
Contributors: J Stapleton (Contributor) - University of Iowa, Internal Medicine
Resource Type: Journal article
Publication Details: International Journal of Cancer, Vol.7(1), pp.106-116
DOI: 10.1002/ijc.26362
PMID: 21858807
NLM abbreviation: Radiat Oncol Investig
ISSN: 1065-7541
eISSN: 1520-6823
Publisher: Wiley Subscription Services, Inc., A Wiley Company
Number of pages: 11
Language: English
Date published: 07/01/2012
Academic Unit: Microbiology and Immunology; Infectious Diseases; Internal Medicine
Record Identifier: 9984094661302771

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