Efficacy of AS04-Adjuvanted Vaccine Against Human Papillomavirus (HPV) Types 16 and 18 in Clearing Incident HPV Infections: Pooled Analysis of Data From the Costa Rica Vaccine Trial and the PATRICIA Study

Authors

Joseph E. Tota, Divison of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA
Frank Struyf, Janssen Research & Development, Beerse, Belgium
Allan Hildesheim, Divison of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA
Paula Gonzalez, Agencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, Guanacaste, Costa Rica
Martin Ryser, GlaxoSmithKline Biologicals, Wavre, Belgium
Rolando Herrero, Agencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, Guanacaste, Costa Rica Section of Early Detection and Prevention, International Agency for Research on Cancer, Lyon, France
John Schussler, Information Management Services, Rockville, Maryland, USA
Naveen Karkada, GlaxoSmithKline Biologicals, Wavre, Belgium
Ana Cecilia Rodriguez, Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica
Nicolas Folschweiller, GlaxoSmithKline Biologicals, Wavre, Belgium
Carolina Porras, Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica
Mark Schiffman, Divison of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.
John T. Schiller, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA
Wim Quint, DDL Diagnostic Laboratory, Rijswijk, the Netherlands
Aimée R. Kreimer, Divison of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA
Matti Lehtinen, University of Tampere, School of Public Health, Tampere, Finland
Cosette M. Wheeler, 1 Divison of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA
Joshua N Sampson, Divison of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA

Document Type

Article

Publication Date

5-20-2021

Abstract

Clinical trial data and real-world evidence suggest that the AS04-adjuvanted vaccine targeting human papillomavirus types 16 and 18 (AS04-HPV-16/18) vaccine provides nearly 90% protection against cervical intraepithelial neoplasia grade 3 or higher irrespective of type, among women vaccinated before sexual debut. This high efficacy is not fully explained by cross-protection. Although AS04-HPV-16/18 vaccination does not affect clearance of prevalent infections, it may accelerate clearance of newly acquired infections. We pooled data from 2 large-scale randomized controlled trials to evaluate efficacy of the AS04-HPV-16/18 vaccine against clearance of nontargeted incident infections. Results of our analysis do not suggest an effect in expediting clearance of incident infections.

Recommended Citation

Tota JE, Struyf F, Hildesheim A, Gonzalez P, Ryser M, Herrero R, Schussler J, Karkada N, Rodriguez AC, Folschweiller N, Porras C, Schiffman M, Schiller JT, Quint W, Kreimer AR, Lehtinen M, Wheeler CM, Sampson JN. Efficacy of AS04-Adjuvanted Vaccine Against Human Papillomavirus (HPV) Types 16 and 18 in Clearing Incident HPV Infections: Pooled Analysis of Data From the Costa Rica Vaccine Trial and the PATRICIA Study. J Infect Dis. 2021 May 20;223(9):1576-1581. doi: 10.1093/infdis/jiaa561. PMID: 32887990; PMCID: PMC8248553.