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
vol.70, no.4, pp.368-373, 2017 (Released:2017-07-24)
参考文献数
23

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

言及状況

外部データベース (DOI)

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https://t.co/c15EA7dkBb 9価HPVワクチンは日本人に多いHPV52,58型もカバーする。100人の被験者でのデータが公開。従来のワクチンでの重篤な副反応の発生率は0.1%、1000人に1人。9価ワクチンに変更される可能性が高い。副反応が同程度だと問題。

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