Immunogenicity and Safety of Human Papillomavirus-16/18 AS04-Adjuvanted Cervical Cancer Vaccine Coadministered With Combined Diphtheria-Tetanus-Acellular Pertussis–inactivated Poliovirus Vaccine to Girls and Young Women
Received 24 July 2009; accepted 18 November 2009.
Abstract
Purpose
Many countries recommend human papillomavirus (HPV) vaccination in female adolescents at an age when other vaccines are routinely administered. This open, randomized, multicenter study (108464/NCT00426361) evaluated coadministration of HPV-16/18 AS04-adjuvanted vaccine with diphtheria-tetanus-acellular pertussis–inactivated poliovirus vaccine (dTpa-IPV).
Methods
Healthy females aged 10–18 years were randomized to receive HPV vaccine at months 0, 1, and 6 (n = 248), HPV vaccine coadministered with dTpa-IPV at month 0 and HPV vaccine at months 1 and 6 (n = 255), or dTpa-IPV at month 0 followed by HPV vaccine at months 1, 2, and 7 (n = 248). Immunogenicity was evaluated at months 0, 1, and 7 or 8 (depending on group). Vaccine reactogenicity and safety were also assessed.
Results
Coadministered dTpa-IPV and HPV vaccine was noninferior to dTpa-IPV alone in terms of seroprotection against diphtheria (99.2% and 100%), tetanus (100% and 100%) and poliovirus types 1, 2, and 3 (≥99.6%), and geometric mean antibody concentrations (ELISA Units/mL) for pertussis toxoid (84 vs. 75), filamentous hemagglutinin (612 and 615) and pertactin (426 and 360) at month 1. Coadministered dTpa-IPV and HPV vaccine was noninferior to HPV vaccine alone in terms of seroconversion rates for HPV-16 (99.5% and 100%) and HPV-18 (99.5% and 100%) and geometric mean antibody titers (ELISA Units/mL) for HPV-16 (15,608 and 18,965) and HPV-18 (6,597 and 6,902) at month 7. Coadministration was generally well tolerated. The reactogenicity of dTpa-IPV and the first dose of HPV vaccine was similar.
Conclusions
Results from this study support coadministration of the HPV-16/18 AS04-adjuvanted vaccine with dTpa-IPV vaccine in females aged 10–18 years.
jGlaxoSmithKline Biologicals, King of Prussia, Pennsylvania
Address correspondence to: José Garcia-Sicilia, M.D., Hospital Infantil Universitario La Paz, Madrid, Spain.
Conflict of interest: Gregory Catteau, Dominique Descamps, Kurt Dobbelaere, Gary Dubin, and Florence Thomas are employees of GlaxoSmithKline Biologicals; Jose Garcia-Sicilia has participated, as a principal investigator, in clinical trials on vaccines, funded by GlaxoSmithKline; Alfonso Carmona has participated, as an investigator, in several clinical trials funded by GlaxoSmithKline; Enrique Bernaola Iturbe is on the Speaker's Bureau for GlaxoSmithKline, Sanofi Pasteur, MSD and Wyeth and is also an advisory board member for AstraZeneca; Tino F. Schwarz, Klaus Peters, Jean-Elie Malkin, and Phu M. Tran have no conflict of interest with regard to this study.
ABSTRACT