Randomized Open Trial Comparing 2-Dose Regimens of the Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Girls Aged 9-14 Years Versus a 3-Dose Regimen in Women Aged 15-25 Years.

Autor:	Puthanakit T; Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand., Huang LM; Department of Pediatrics, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei., Chiu CH; Division of Pediatric Infectious Diseases, Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung University College of Medicine, Kweishan, Taoyuan., Tang RB; Department of Pediatrics, Cheng Hsin General Hospital, Taipei, Taiwan., Schwarz TF; Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany., Esposito S; Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Cá Granda Ospedale Maggiore Policlinico, Milan, Italy., Frenette L; Q&T Research Incorporated, Sherbrooke, Québec, Canada., Giaquinto C; Dipartimento di Pediatria, Azienda Ospedaliera Universitaria di Padova, Italy., McNeil S; Canadian Center for Vaccinology, IWK Health Centre and NovaScotia Health Authority, Dalhousie University, Halifax., Rheault P; Medicor Research Inc, Sudbury, Ontario, Canada., Durando P; Department of Health Sciences, School of Medical and Pharmaceutical Sciences, Vaccines and Clinical Trials Unit, IRCCS AOU San Martino-IST, University of Genoa, Italy., Horn M; Pediatric Office Dr. med. Michael Horn, Bavaria., Klar M; Department of Obstetrics and Gynecology, Freiburg Medical School, Germany., Poncelet S; GSK Vaccines, Rixensart., De Simoni S; GSK Vaccines, Rixensart., Friel D; GSK Vaccines, Wavre, Belgium., De Muynck B; GSK Vaccines, Wavre, Belgium., Suryakiran PV; GSK Pharmaceuticals India Ltd., Bangalore, Karnataka, India., Hezareh M; Chiltern International for GSK, Wavre, Belgium., Descamps D; GSK Vaccines, Wavre, Belgium., Thomas F; GSK Vaccines, Wavre, Belgium., Struyf F; GSK Vaccines, Wavre, Belgium.
Jazyk:	angličtina
Zdroj:	The Journal of infectious diseases [J Infect Dis] 2016 Aug 15; Vol. 214 (4), pp. 525-36. Date of Electronic Publication: 2016 Feb 03.
DOI:	10.1093/infdis/jiw036
Abstrakt:	Background: This randomized, open trial compared regimens including 2 doses (2D) of human papillomavirus (HPV) 16/18 AS04-adjuvanted vaccine in girls aged 9-14 years with one including 3 doses (3D) in women aged 15-25 years. Methods: Girls aged 9-14 years were randomized to receive 2D at months 0 and 6 (M0,6; (n = 550) or months 0 and 12 (M0,12; n = 415), and women aged 15-25 years received 3D at months 0, 1, and 6 (n = 482). End points included noninferiority of HPV-16/18 antibodies by enzyme-linked immunosorbent assay for 2D (M0,6) versus 3D (primary), 2D (M0,12) versus 3D, and 2D (M0,6) versus 2D (M0,12); neutralizing antibodies; cell-mediated immunity; reactogenicity; and safety. Limits of noninferiority were predefined as <5% difference in seroconversion rate and <2-fold difference in geometric mean antibody titer ratio. Results: One month after the last dose, both 2D regimens in girls aged 9-14 years were noninferior to 3D in women aged 15-25 years and 2D (M0,12) was noninferior to 2D (M0,6). Geometric mean antibody titer ratios (3D/2D) for HPV-16 and HPV-18 were 1.09 (95% confidence interval, .97-1.22) and 0.85 (.76-.95) for 2D (M0,6) versus 3D and 0.89 (.79-1.01) and 0.75 (.67-.85) for 2D (M0,12) versus 3D. The safety profile was clinically acceptable in all groups. Conclusions: The 2D regimens for the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9-14 years (M0,6 or M0,12) elicited HPV-16/18 immune responses that were noninferior to 3D in women aged 15-25 years. Clinical Trials Registration: NCT01381575. (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu