Evaluation of safety and potency of Japanese encephalitis vaccine produced by Beijing-1 strai

ABSTRACT

The pilot study was performed on the first 5 lots of the Japanese encephalitis vaccine produced by Beijing-1 strain: JB011203, JB021203, JB030104, JB040204 and JB050304 to evaluate their safety and potency. The quality control consists of abnormal toxicity, specific safety, pyrogen, sterility and potency test. All of 5 lots were passed the minimum requirements of biological products of Japan. The mice and guinea pigs were healthy, body weigh increased. Non of bacteria and fungi grown in both medium Thioglycholate and Soybeancasein. The pyrogen test on rabbits was passed in 5/5 lots. Summed temperature response of 3 rabbits per lot were 0°C-0.3°C (WHO requirement ≤1.4°C). Potency test was evaluated by PRNT compared with reference EJP034A of BIKEN. After the second immunization the neutralizing antibody response > reference from 0.04 to 0.2 log. 5/5 lots were passed the safety and potency test and met the minimum requirement of biological products of WHO.