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J Infect Dis. 2017 Jun 1;215(11):1711-1719. doi: 10.1093/infdis/jix154.

Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9-14 Years: A Randomized Trial.

Author information

1
Department of Pediatrics, National Taiwan University Children's Hospital, National Taiwan University, Taipei.
2
Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, and Research Unit in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Thailand.
3
Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung University, Taoyuan.
4
Department of Pediatrics, Cheng Hsin General Hospital, Taipei, Taiwan.
5
Central Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg.
6
Department Distretto di Dronero, Azienda Sanitaria Locale Cuneo 1, Cuneo.
7
Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' GrandaOspedale Maggiore Policlinico, Milan.
8
Q&T Research Incorporated, Sherbrooke.
9
Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax.
10
Department of Health Sciences, University of Genoa and IRCCS AOU San Martino-IST, Genoa.
11
Medicor Research Inc, Sudbury.
12
Department of Women's and Children's Health, University of Padova, Padua, Italy.
13
Schoenau am Koenigssee.
14
Department of Gynaecology and Obstetrics, Klinikum Wolfsburg, Wolfsburg.
15
Facharzt für Frauenheilkunde und Geburtshilfe, Hamburg.
16
Manna Research, Toronto, Canada.
17
Medizinische Hochschule Hannover, Hannover, Germany.
18
GSK.
19
GSK, Bangalore, India.
20
Chiltern International for GSK, Wavre, Belgium.

Abstract

Background:

We previously reported the noninferiority 1 month after the last dose of 2-dose human papillomavirus 16/18 AS04-adjuvanted (AS04-HPV-16/18) vaccine schedules at months 0 and 6 (2D_M0,6) and months 0 and 12 (2D_M0,12) in girls aged 9-14 years compared with a 3-dose schedule at months 0, 1, and 6 (3D_M0,1,6) in women aged 15-25 years. Here, we report the results at study end (month 36 [M36]).

Methods:

Girls were randomized 1:1 and received 2 vaccine doses either 6 months (2D_M0,6) or 12 months apart (2D_M0,12); women received 3 doses at months 0, 1, and 6 (3D_M0,1,6). Endpoints included noninferiority of HPV-16/18 antibodies for 2D_M0,6 versus 3D_M0,1,6; 2D_M0,12 versus 3D_M0,1,6; and 2D_M0,12 versus 2D_M0,6; and assessment of neutralizing antibodies, T cells, B cells, and safety.

Results:

At M36, the 2D_M0,6 and 2D_M0,12 schedules remained noninferior to the 3D_M0,1,6 schedule in terms of seroconversion rates and 3D/2D geometric mean titers for anti-HPV-16 and anti-HPV-18. All schedules elicited sustained immune responses up to M36.

Conclusions:

Both 2-dose schedules in young girls remained noninferior to the 3-dose schedule in women up to study conclusion at M36. The AS04-HPV-16/18 vaccine administered as a 2-dose schedule was immunogenic and well tolerated in young girls.

KEYWORDS:

2-dose schedule; Cervarix; cervical cancer; human papillomavirus (HPV)

PMID:
28591778
PMCID:
PMC5853959
DOI:
10.1093/infdis/jix154
[Indexed for MEDLINE]
Free PMC Article

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