Clinical evaluation of the lot-to-lot consistency of an enterovirus 71 vaccine in a commercial-scale phase IV clinical trial.

Autor:	Chen J; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Jin P; Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, Jiangsu, China., Chen X; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Mao Q; Division of Hepatitis virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Beijing, China., Meng F; Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, Jiangsu, China., Li X; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Chen W; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Du M; Department of Disease Prevention and Control, Pei County Center for Disease Control and Prevention, Pei County, Jiangsu, China., Gao F; Division of Hepatitis virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Beijing, China., Liu P; School of Public Health, Southeast University, Nanjing, Jiangsu, China., Li X; Department of Disease Prevention and Control, Pei County Center for Disease Control and Prevention, Pei County, Jiangsu, China., Guo C; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Xie T; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Lu W; Department of Research and Development, National Vaccine & Serum Institute, Beijing, China., Li Q; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Li L; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Yan X; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Guo X; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Du H; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Li X; Department of Research and Development, Shanghai Institute of Biological Products Co., Ltd, Shanghai, China., Duan K; Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China., Zhu F; Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, Jiangsu, China.
Jazyk:	angličtina
Zdroj:	Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2022 Nov 30; Vol. 18 (5), pp. 2063630. Date of Electronic Publication: 2022 Jun 17.
DOI:	10.1080/21645515.2022.2063630
Abstrakt:	Objective: To evaluate the immunogenicity, safety and lot-to-lot consistency of an inactivated enterovirus 71 (EV71) vaccine cultured in bioreactors with different specifications after full immunization. Methods: A randomized, double-blind trial was performed in 3,000 children aged 6 ~ 35 months with six vaccine batches, which were prepared in 40 L and 150 L bioreactors for three consecutive batches respectively. Children were immunized on day 0 and 28, serum samples were collected on day 0 and 56, and neutralizing antibody titers were determined by the microcytopathic method. Immediate reactions were recorded within 30 min, local and systemic symptoms were recorded within 0 ~ 28 days, and serious adverse events were recorded within 6 months. Results: After immunization with two doses of the inactivated EV71 vaccine, the neutralizing antibody GMT was 825.52 ± 4.09, and the positive conversion rate was 96.18%, with no significant difference. The 95% CI of the serum neutralizing antibody GMT ratio between the two groups after immunization with the three vaccine batches produced in the 150 L and 40 L bioreactors ranged from .67 ~ 1.5. The overall incidence of adverse reactions, mainly grade 1 reactions, for all 6 batches from 0 to 28 days after vaccination was 49.62%, with no significant difference (p = .8736). The incidence of systemic adverse reactions, primarily fever and diarrhea, was 45.14%; the incidence of local adverse reactions, primarily erythema and tenderness, was 9.43%. Conclusion: The EV71 vaccine was highly immunogenic and safe in children aged 6-35 months, and 6 consecutive batches produced by the two bioreactors with different specifications were consistent.
Databáze:	MEDLINE
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