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背景;亚太地区已经暴发了大规模的EV71病毒感染。该病毒感染有严重的并发症,包括脑炎和脊髓灰质炎样麻痹,心肺衰竭等,最终导致死亡。因此迫切需要一个有效的针对EV71病毒的疫苗。方法;在I期随机非盲临床试验中,我们评估了由非洲绿猴肾细胞培养的灭活铝佐剂全病毒EV71疫苗的安全性和免疫原性。60个健康的年龄在20~60岁之间的志愿者分别接种了两种剂量的疫苗,在接下来的21 d分开观察。第一种剂量含有5μg的EV71病毒抗原以及150μg的佐剂(A05组),另外一种剂量含有10μg的EV71病毒抗原以及300
Background; Large-scale EV71 virus infection has been reported in the Asia-Pacific region. The virus infection has serious complications, including encephalitis and poliomyelitis-like paralysis, cardiopulmonary failure, etc., eventually leading to death. There is an urgent need for a vaccine that is effective against the EV71 virus. Methods; In a phase I, randomized, non-blind clinical trial, we evaluated the safety and immunogenicity of the inactivated aluminum adjuvanted full-virulent EV71 vaccine grown in African green monkey kidney cells. Sixty healthy volunteers aged 20 to 60 were vaccinated with two doses of vaccine and observed separately for the next 21 days. The first dose contained 5 [mu] g EV71 antigen and 150 [mu] g adjuvant (A05 group) and the other contained 10 [mu] g EV71 virus antigen and 300