严重急性呼吸综合征冠状病毒灭活疫苗I期试验的安全性和免疫原性
Safety and immunogenicity from a phase I trial of inactivated severe acute respiratory syndrome coronavirus vaccine.
作者信息
Lin Jiang-Tao, Zhang Jian-San, Su Nan, Xu Jian-Guo, Wang Nan, Chen Jiang-Ting, Chen Xin, Liu Yu-Xuan, Gao Hong, Jia Yu-Ping, Liu Yan, Sun Rui-Hua, Wang Xu, Yu Dong-Zheng, Hai Rong, Gao Qiang, Ning Ye, Wang Hong-Xia, Li Ma-Chao, Kan Biao, Dong Guan-Mu, An Qi, Wang Ying-Qun, Han Jun, Qin Chuan, Yin Wei-Dong, Dongs Xiao-Ping
机构信息
Beijing China-Japan Friendship Hospital, People's Republic of China.
出版信息
Antivir Ther. 2007;12(7):1107-13.
BACKGROUND
Emergence of severe acute respiratory syndrome (SARS) from the winter of 2002 to the spring of 2003 has caused a serious threat to public health.
METHODS
To evaluate the safety and immunogenicity of the inactivated SARS coronavirus (SARS-CoV) vaccine, 36 subjects received two doses of 16 SARS-CoV units (SU) or 32 SU inactivated SARS-CoV vaccine, or placebo control.
RESULTS
On day 42, the seroconversion reached 100% for both vaccine groups. On day 56, 100% of participants in the group receiving 16 SU and 91.1% in the group receiving 32 SU had seroconverted. The geometric mean titre of neutralizing antibody peaked 2 weeks after the second vaccination, but decreased 4 weeks later.
CONCLUSION
The inactivated vaccine was safe and well tolerated and can elicit SARS-CoV-specific neutralizing antibodies.
背景
2002年冬到2003年春严重急性呼吸综合征（SARS）的出现对公众健康造成了严重威胁。
方法
为评估灭活SARS冠状病毒（SARS-CoV）疫苗的安全性和免疫原性，36名受试者接种了两剂16个SARS-CoV单位（SU）或32个SU的灭活SARS-CoV疫苗，或接受安慰剂对照。
结果
在第42天，两个疫苗组的血清转化率均达到100%。在第56天，接受16个SU组的100%参与者和接受32个SU组的91.1%参与者发生了血清转化。中和抗体的几何平均滴度在第二次接种后2周达到峰值，但在4周后下降。
结论
该灭活疫苗安全且耐受性良好，可引发SARS-CoV特异性中和抗体。
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