- 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
- 10
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.
- 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
- 6 10
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.