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Efficacy of Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Japanese Women Aged 20 to 25 Years: Interim Analysis of a Phase 2 Double-Blind, Randomized, Controlled Trial
  1. Ryo Konno, MD, PhD*,
  2. Shinobu Tamura, MPharm,
  3. Kurt Dobbelaere, MD and
  4. Hiroyuki Yoshikawa, MD, PhD§
  1. *Department of Obstetrics and Gynecology, Jichi Medical University, Saitama Medical Center, Omiya-ku, Saitama, Saitama;
  2. Vaccine Clinical Development, GlaxoSmithKline K.K., Shibuya-ku, Tokyo, Japan;
  3. Global Clinical Research and Development Department, GlaxoSmithKline Biologicals, Rixensart, Belgium; and
  4. §Department of Obstetrics and Gynecology, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.
  1. Address correspondence and reprint requests to Ryo Konno, MD, PhD, Jichi Medical University, Saitama Medical Center, 1-847, Amanuma, Omiya-ku, Saitama, Saitama 330-8503, Japan. E-mail: kryo772007{at}yahoo.co.jp.

Abstract

Background: A phase 2 double-blind, controlled, randomized multicenter study with human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine is ongoing in healthy Japanese women aged 20 to 25 years. We assessed the vaccine efficacy in the event-triggered analysis.

Methods: Japanese women aged 20 to 25 years were randomly assigned to receive either HPV-16/18 AS04-adjuvanted (n = 519) or hepatitis A (n = 521) vaccine at 0, 1, and 6 months. The women were assessed for virological and cytological end points associated with HPV-16/18 in cervical specimens and for the vaccine safety and immunogenicity.

Results: The mean length of follow-up for women in the primary analysis for efficacy at the time of a prespecified event-triggered interim analysis was 13.6 months after the first vaccination. Vaccine efficacy against HPV-16/18 persistent infections (6-month definition) in the according-to-protocol cohort for efficacy was 100% (99% confidence interval, 20.5-100, P = 0.0037). At 6 months after the third dose of vaccine, geometric mean titers against HPV-16 and HPV-18 were 2899.3 and 1352.2 enzyme-linked immunosorbent assay units per milliliter, respectively, that is, 97- and 60-fold higher than geometric mean titers observed after natural infection. There were no clinically meaningful differences in safety between the HPV and control group.

Conclusions: The HPV-16/18 AS04-adjuvanted vaccine was as efficacious in Japan as in other countries and was generally safe and highly immunogenic in Japanese women.

  • Human papillomavirus
  • HPV-16/18 AS04-adjuvanted vaccine
  • Cervical cancer
  • Persistent infection
  • Efficacy

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Footnotes

  • This study was funded and coordinated by GlaxoSmithKline Biologicals (Rixensart, Belgium) and GlaxoSmithKline K.K. (Tokyo, Japan).

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