著者
Satoshi Iwata Shinya Murata Shi Rong Han Akira Wakana Miyuki Sawata Yoshiyuki Tanaka
出版者
National Institute of Infectious Diseases, Japanese Journal of Infectious Diseases Editorial Committee
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
被引用文献数
3 4

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)

Twitter (13 users, 16 posts, 5 favorites)

ガーダシル9の申請が出されてから約3年間経過、未承認薬。日本の治験データは100人の小規模データ。重篤有害事象はないが、痛みや腫れは強い。 Safety and Immunogenicity of a 9-Valent Human… https://t.co/D8XJEsxNce
堀成美氏、9価ワクチンの 評価を 紹介。 https://t.co/0mJ7J4AtlN https://t.co/Gt5PMH2jqu
日本の女性での9価HPVワクチン接種の評価 (全文フリーアクセス JJID 2017年7月) https://t.co/8TPN17avk3
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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