著者

Satoshi Iwata Shinya Murata Shi Rong Han Akira Wakana Miyuki Sawata Yoshiyuki Tanaka

出版者

国立感染症研究所 Japanese Journal of Infectious Diseases 編集委員会

雑誌

Japanese Journal of Infectious Diseases (ISSN:13446304)

巻号頁・発行日

pp.JJID.2016.299, (Released:2016-12-22)

参考文献数

23

被引用文献数

6

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A 9-valent human papillomavirus (HPV 6/11/16/18/31/33/45/52/58) virus-like particle (VLP) vaccine (9vHPV) has been proven highly efficacious in preventing anogenital disease related with vaccine HPV types in a pivotal Phase III study in women aged 16 to 26 years. We report here the results of an open-label phase III study conducted to bridge the findings in women age 16 to 26 years to Japanese girls aged 9 to 15 years. All subjects (n = 100) received a 3-dose regimen of 9vHPV vaccine at day 1, month 2 and month 6. Anti-HPV serologic assays were performed at day 1, month 7, month 12, month 24 and month 30. At month 7 (4 weeks after dose 3), 100% of subjects seroconverted for each vaccine HPV type. Increases in geometric mean titers of anti-HPV 6/11/16/18/31/33/45/52/58 in girls were similar to those in Japanese women aged 16 to 26 years in the pivotal phase III study. Persistence of anti-HPV responses was observed through 2 years after dose 3. In addition, administration of 9vHPV vaccine was generally well tolerated in Japanese girls.