Bivalent Human Papillomavirus Vaccine Effectiveness in a Japanese Population: High Vaccine-Type-Specific Effectiveness and Evidence of Cross-Protection

Risa Kudo, Manako Yamaguchi, Masayuki Sekine* (Corresponding Author), Sosuke Adachi, Yutaka Ueda, Etsuko Miyagi, Megumi Hara, Sharon J. B. Hanley, Takayuki Enomoto

*Corresponding author for this work

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BACKGROUND: Proactive recommendations for human papillomavirus (HPV) vaccines in Japan have been suspended for 5 years because of safety concerns. While no scientific evidence exists to substantiate these concerns, one reason given for not reinstating recommendations is the lack of reliable vaccine effectiveness (VE) data in a Japanese population. This study reports the VE of the bivalent HPV vaccine in Japanese women aged 20-22 years. METHODS: During cervical screening between 2014 and 2016, women had Papanicolaou smears and HPV tests performed and provided data about their sexual history. Estimates of VE for vaccine-targeted HPV type 16 (HPV16) and 18 and cross-protection against other types were calculated. RESULTS: Overall, 2197 women were tested, and 1814 were included in the analysis. Of these, 1355 (74.6%) were vaccinated, and 1295 (95.5%) completed the 3-dose schedule. In women sexually naive at vaccination, the pooled VEs against HPV16 and 18 and for HPV31, 45, and 52 were 95.5% (P < .01) and 71.9% (P < .01), respectively. When adjusted for number of sex partners and birth year, pooled VEs were 93.9% (P = .01) and 67.7% (P = .01) for HPV16 and 18 and HPV31, 45, and 52, respectively. CONCLUSIONS: The bivalent HPV vaccine is highly effective against HPV16 and 18. Furthermore, significant cross-protection against HPV31, 45, and 52 was demonstrated and sustained up to 6 years after vaccination. These findings should reassure politicians about the VE of bivalent HPV vaccine in a Japanese population.
Original languageEnglish
Pages (from-to)382-390
Number of pages9
JournalThe journal of infectious diseases
Issue number3
Early online date9 Oct 2018
Publication statusPublished - 1 Feb 2019

Bibliographical note

Acknowledgments.  We thank Dr Tomomi Egawa-Takata, Dr Akiko Morimoto, Dr Yusuke Tanaka, Ms Asami Yagi, Ms Yuka Watanabe, Ms Sachiko Ono, Ms Anna Ishida, and the administrators of Niigata, Nagaoka, Shibata, Sanjo, Joetsu, and Mitsuke cities for their support in conducting the survey.

Financial support. This work was supported by the Health and Labor Sciences Research Grant (26272001) and the Japanese Agency for Medical Research and Development (AMED) under grant number JP15ck0106103 and JP17ck0106369.


  • HPV vaccine
  • HPV infection
  • cervical cancer
  • vaccine effectiveness
  • cross-protection
  • bivalent vaccine


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