H5N1 avian influenza vaccine for human use test evaluation.docVIP

 PAGE \* MERGEFORMAT 17 H5N1 avian influenza vaccine for human use test evaluation Author: Zhu Zhiyong, Ding Hang, Zhu Han-ping, LI Yan Jin, Chen Xue-Kui, Shen brothers, Zhang Tao, Pei-jiang, YAO Ping-ping, Xu, Weng-Qing, Gong Yue, Zhi-Hong Guo, Su-Bo, Sun Shubin, Liang Weifeng Keywords: bird flu vaccine; production process; vaccine test; vaccine quality Abstract: Objective selection of H5N1 avian influenza virus seed (R1194 and R1203), according to the design of the production process, made the vaccine conduct a comprehensive inspection, select one of the better production of the vaccine strains used for bird flu vaccine for human use after the pre-clinical studies animal immunization. Methods imported from abroad two H5N1 avian influenza virus, design and production of three kinds of vaccines (whole virus, cracking -1, pyrolysis -2) of the purification process, optimize the purification conditions for a comprehensive test of the vaccine made to compare two kinds of poisonous vaccine production quality. The results of two strains in the vaccine titer 104EID50/ml (half of the chick embryo infective dose / ml), culture temperature 345 ℃, under the conditions of incubation time 3d, a high titer of virus multiplication; test results prove that all the vaccine made reflect the quality of endotoxin, egg albumin, total protein, total protein and hemagglutinin than that of the four indicators, much better than the national standard; three kinds of processes of vaccines completely different form of electron microscopy; by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS), whole-virus vaccines and vaccine cracking -2 protein band patterns similar, but the cracking -1 vaccine at about 32KD band missing; R1203 strain of vaccine virus seed production significantly higher than the R1194 strain. Conclusion production of vaccines designed for three kinds of purification processes, can produce high-quality vaccines; poisonous kinds of R1203 strain