2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study.

Autor:	Mingwei Wei, Fanyue Meng, Shiyuan Wang, Jingxin Li, Yuntao Zhang, Qunying Mao, Yuemei Hu, Pei Liu, Nianmin Shi, Hong Tao, Kai Chu, Yuxiao Wang, Zhenglun Liang, Xiuling Li, Fengcai Zhu, Wei, Mingwei, Meng, Fanyue, Wang, Shiyuan, Li, Jingxin, Zhang, Yuntao
Předmět:	IMMUNOGENETICS VACCINE biotechnology PLACEBOS INFANT care IMMUNOLOGY ANIMAL experimentation CLINICAL trials COMPARATIVE studies ENTEROVIRUS diseases ENTEROVIRUSES IMMUNIZATION IMMUNOGLOBULINS LONGITUDINAL method RESEARCH methodology MEDICAL cooperation MEDICAL protocols RESEARCH TIME VACCINES VIRAL antibodies VIRAL vaccines EVALUATION research RANDOMIZED controlled trials BLIND experiment PREVENTION
Zdroj:	Journal of Infectious Diseases; Jan2017, Vol. 215 Issue 1, p56-63, 8p
Abstrakt:	Background:  This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine.Method:  In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years.Results:  Overall efficacy was 94.84% (95% confidence interval [CI], 83.53%-98.38%) during the 2-year follow-up period (P < .0001), and the vaccine efficacy during the second year was 100.00% (95% CI, 84.15%-100.00%) against EV71-associated hand-foot-and-mouth disease (HFMD; P < .0001). Geometric mean titers of neutralizing antibody in participants remained high during the 2-year follow-up period, and no vaccine-related serious adverse events were recorded.Conclusions:  Two doses of Vigoo EV71 vaccine could provide sustained protection against EV71-associated HFMD in healthy Chinese children.Clinical Trials Registration:  NCT01508247. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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