Safety and immunogenicity from a phase I trial of inactivated severe acute respiratory syndrome coronavirus vaccine.

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

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.