Session Title: VACCINE AND PREVENTION
CO-ADMINISTRATION OF AS04‑ADJUVANTED HPV-16/18 CERVICAL CANCER VACCINE WITH DTPA‑IPV IN 10-18-YEAR-OLD GIRLS: MONTH 7 RESULTS FROM A RANDOMIZED TRIAL
T. Schwarz1, J. Garcia-Sicilia2, A. Carmona3, J.E. Malkin4, M. Tran5, K. Peters6, P. Hillemanns7, G. Catteau8, F. Thomas8, K. Dobbelaere8, D. Descamps8, G. Dubin9
1Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Wuerzburg, Germany, 2Hospital Materno-Infantil La Paz, Madrid, 3Instituto Hispalense de Pediatría, Sevilla, Spain, 4Centre Médical de l'Institut Pasteur, Paris, 5Cabinet Médical Tran, Nice, France, 6Praxis, Hamburg, 7Klinik für Frauenheilkunde und Geburtshilfe, Medizinische Hochschule Hannover, Hannover, Germany, 8GlaxoSmithKline Biologicals, Rixensart, Belgium, 9GlaxoSmithKline Biologicals, King of Prussia, USA
Background: Human papillomavirus (HPV) vaccination in adolescent girls occurs at an age when other vaccines are routinely administered.This randomized, open, multicenter study (108464/NCT00426361) evaluated co‑administration of HPV‑16/18 AS04‑adjuvanted vaccine with diphtheria‑tetanus‑acellular pertussis‑inactivated poliovirus vaccine (dTpa‑IPV).
Methods: Healthy girls aged 10‑18 years were randomized to receive HPV vaccine at Months 0, 1 and 6 (n=248), HPV vaccine co‑administered 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 7/8.
Results: The dTpa‑IPV immune response at Month 1 (primary objective) was non‑inferior when dTpa-IPV vaccine was co‑administered with HPV vaccine, versus dTpa‑IPV alone, for seroprotection rates for anti‑diphtheria, anti‑tetanus and anti‑poliovirus (≥99.2%), and GMTs (EU/mL) for anti‑pertussis toxoid (84.2 and 75.4), anti-filamentous haemagglutinin (611.7 and 615.2) and anti-pertactin (426.2 and 360.0), respectively. The HPV-16/18 immune response at Month 7 (secondary objective) was non-inferior when HPV vaccine was co‑administered with dTpa‑IPV, versus HPV vaccine alone (see figure).Co‑administration was generally well‑tolerated. Reactogenicity of dTpa‑IPV and HPV vaccines post‑dose‑1 was generally similar. No subjects withdrew due to adverse events and no vaccine-related SAEs were reported.
Conclusions: Immunogenicity and tolerability results support co‑administration of HPV‑16/18 AS04‑adjuvanted cervical cancer vaccine with dTpa‑IPV in girls aged 10-18 years.
For HPV Vaccine Adolescent Study Investigators Network.