Regulatory aspects of quality and safety for live recombinant viral vaccines against infectious diseases in Japan

被引：5

作者：

Sakurai, Akira ^{[1
]}

Ogawa, Takashi ^{[1
]}

Matsumoto, Jun ^{[1
]}

Kihira, Tetsunari ^{[1
]}

Fukushima, Shinji ^{[2
]}

Miyata, Ippei ^{[3
]}

Shimizu, Hideaki ^{[4
]}

Itamura, Shigeyuki ^{[5
]}

Ouchi, Kazunobu ^{[3
]}

Hamada, Atsuro ^{[2
]}

Tani, Kenzaburo ^{[6
]}

Okabe, Nobuhiko ^{[4
]}

Yamaguchi, Teruhide ^{[7
]}

机构：

[1] Pharmaceut & Med Devices Agcy, Off Vaccines & Blood Prod, Chiyoda Ku, Shin Kasumigaseki Bldg,3-3-2 Kasumigaseki, Tokyo 1000013, Japan

[2] Tokyo Med Univ Hosp, Travellers Med Ctr, Shinjuku Ku, 6-7-1 Nishishinjuku, Tokyo 1600023, Japan

[3] Kawasaki Med Sch, Dept Pediat, 577 Matsushima, Kurashiki, Okayama 7010192, Japan

[4] Kawasaki City Inst Publ Hlth, Life Sci & Environm LiSE Res Ctr, Kawasaki Ku, 2F,3-25-13 Tono Machi, Kawasaki, Kanagawa 2100821, Japan

[5] Natl Inst Infect Dis, 4-7-1 Gakuen, Musashimurayama, Tokyo 2080011, Japan

[6] Univ Tokyo, Inst Med Sci, Project Div ALA Adv Med Res, Minato Ku, 4-6-1 Shirokanedai, Tokyo 1088639, Japan

[7] Nihon Pharmaceut Univ, Div Pharmacol, 10281 Komuro, Ina, Saitama 3620806, Japan

来源：

VACCINE | 2019年 / 37卷 / 43期

关键词：

BACKBONE STANDARDIZED TEMPLATE; EBOLA-VIRUS DISEASE; KEY CONSIDERATIONS; RING VACCINATION; GUINEA;

D O I：

10.1016/j.vaccine.2019.08.031

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Recombinant viral vaccines expressing antigens of pathogenic microbes (e.g., HIV, Ebola virus, and malaria) have been designed to overcome the insufficient immune responses induced by the conventional vaccines. Our knowledge of and clinical experience with the new recombinant viral vaccines are insufficient, and a clear regulatory pathway is needed for the further development and evaluation of recombinant viral vaccines. In 2018, the research group supported by the Ministry of Health, Labour and Welfare, Japan (MHLW) published a concept paper to address the development of recombinant viral vaccines against infectious diseases. Herein we summarize the concept paper-which explains the Japanese regulatory concerns about recombinant viral vaccines-and provide a focus of discussion about the development of recombinant viral vaccines. (C) 2019 The Authors. Published by Elsevier Ltd.

引用

页码：6573 / 6579

页数：7

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