A simulated, randomized study on the safety and immunogenicity of three consecutive commercial-scale batches of the CTN-1V strain human rabies vaccine to verify the inter-batch consistency-Reference-Cited by-同舟云学术

A simulated, randomized study on the safety and immunogenicity of three consecutive commercial-scale batches of the CTN-1V strain human rabies vaccine to verify the inter-batch consistency

Published:2022-11-21 Issue:6 Volume:18 Page:
ISSN:2164-5515
Container-title:Human Vaccines & Immunotherapeutics
language:en
Short-container-title:Human Vaccines & Immunotherapeutics

Author:

Zhou Lei¹,Liu Jingjing²³,Li Jia³,Liu Xuecheng⁴,Zhang Jingwu¹,Nie Fei¹,Chen Jianmin¹,Chai Jing¹,Lv Jinchao⁵,Wang Minghui⁶,Yu Jiajie⁷,Wu Wenjie⁸,Li Yuhua³^ORCID,Zhang Yuhui¹^ORCID

Affiliation:

1. General Manager Office, Dalian Aleph Biomedical Co., Ltd., Dalian, China

2. State Key Laboratory of Biotherapy, Sichuan University, Chengdu, China

3. Arbovirus Vaccine Department, National Institutes for Food and Drug Control, Beijing, China

4. Vaccine Clinical Research Center, Sichuan Provincial Center for Disease Control and Prevention, Chengdu, China

5. Quality Control Department, Dalian Aleph Biomedical Co., Ltd., Dalian, China

6. R&D Department, Dalian Aleph Biomedical Co., Ltd., Dalian, China

7. Scientific Affairs Department, Simoon Record Beijing Co., Ltd., Beijing, China

8. Project Management Department, Simoon Record Beijing Co., Ltd., Beijing, China

Funder

Key Research and Development Program of Liaoning Provincial Department of Science and Technology

Publisher

Informa UK Limited

Subject

Pharmacology,Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/21645515.2022.2138049

Reference16 articles.

1. Rabies: Still a Uniformly Fatal Disease? Historical Occurrence, Epidemiological Trends, and Paradigm Shifts

2. Estimating the Global Burden of Endemic Canine Rabies

3. A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab™ for pre-exposure use in healthy adults: Results from a randomized controlled phase-II trial

4. World Health Organization. WHO expert consultation on rabies: third report. WHO; 2008. https://apps.who.int/iris/handle/10665/272364.