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

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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.

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

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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.

著者

Shinya Murata Yuzuru Takeuchi Kou Yamanaka Jun Hayakawa Masashige Yoshida Ruriko Yokokawa 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.72, no.5, pp.299-305, 2019 (Released:2019-09-19)

参考文献数

30

被引用文献数

3

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Human papillomavirus (HPV)-associated disease is common among men with HPV infection. A quadrivalent HPV (qHPV) vaccine has demonstrated 85.9% efficacy against HPV6/11/16/18-related, persistent (≥ 6 month) infection in a study of Japanese men aged 16–26 years old. Here, we report the results of an open-label study of the immunogenicity and tolerability of the qHPV vaccine (NCT02576054), conducted to bridge findings from Japanese men to Japanese boys aged 9–15 years old. A total of 100 boys completed a three-vaccination regimen (Day 1, and Months 2 and 6), and 99 boys were included in the primary analysis population. The rate of seroconversion at one month after vaccine Dose 3 (Month 7) was high for each type of HPV (anti-HPV6/11/16/18 seroconversion rates [95% CI]: 94.9% [85.5%, 98.3%], 99.0% [94.4%, 100.0%], 99.0% [94.5%, 100.0%], and 99.0% [94.4%, 100.0%], respectively). Moreover, anti-HPV6/11/16/18 geometric mean titers were 482.9 mMU/mL, 1052.8 mMU/mL, 3878.3 mMU/mL, and 1114.5 mMU/mL, respectively. Immune responses to the qHPV vaccine were non-inferior among Japanese boys included in the current study and compared with young Japanese men from a separate study. Injection-site reactions were the most common adverse events, and administration of the vaccine was well tolerated in Japanese boys.

著者

Shinya Murata Yuzuru Takeuchi Kou Yamanaka Jun Hayakawa Masashige Yoshida Ruriko Yokokawa 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

pp.JJID.2018.448, (Released:2019-05-31)

参考文献数

30

被引用文献数

3

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Human papillomavirus (HPV)-associated disease is common among men with HPV infection. A quadrivalent HPV (qHPV) vaccine has demonstrated 85.9% efficacy against HPV6/11/16/18-related persistent (≥6 month) infection in a study of Japanese men aged 16–26 yr. Here, we report results of an open-label study of the immunogenicity and tolerability of the qHPV vaccine (NCT02576054), conducted to bridge findings in Japanese men to Japanese boys aged 9–15 yr. A total of 100 boys completed a three-vaccination regimen (Day 1, Months 2, and 6), and 99 boys were included in the primary analysis population. The rate of seroconversion at 1 month after vaccine Dose 3 (Month 7) was high for each vaccine HPV type (anti-HPV6/11/16/18 seroconversion rates [95% CI]: 94.9% [85.5%, 98.3%], 99.0% [94.4%, 100.0%], 99.0% [94.5%, 100.0%], and 99.0% [94.4%, 100.0%], respectively) and anti-HPV6/11/16/18 geometric mean titers were 482.9 mMU/mL, 1052.8 mMU/mL, 3878.3 mMU/mL, and 1114.5 mMU/mL, respectively. Immune responses to qHPV vaccine were non-inferior among Japanese boys included in the current study compared with young Japanese men in a separate study. Injection-site reactions were the most common adverse events, and administration of the vaccine was well tolerated in Japanese boys.