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
(Released:2016-12-22)
参考文献数
23

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.

言及状況

外部データベース (DOI)

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@hatatomoko 認可前に我が国で9価のHPVワクチンを百人の少女に打った論文か? https://t.co/fyIjIo5RBi 論文の著者、岩田氏(感染症学教室)以外は、すべて、MSD社員ではないですか!… https://t.co/zCZVB8Vzl1
この論文の冠はあまりに笑える 『Safety』 and ~ study of a 9-valent human papillomavirus vaccine ~ to 9-to-15 year-old Japanese girls… https://t.co/knWlz5jvy8
memo 9価ガーダシル 臨床試験の論文 https://t.co/c3KuMlWLiM 著者: 岩田 敏1、村田 慎也2、韓 士栄2、若菜 明2、澤田 美由紀2、 田中 宜之2 所属: 1 慶應義塾大学(東京都)、2MSD 株式会社(東京都)

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