Safety and Immunogenicity from a Phase I Trial of Inactivated Severe Acute Respiratory Syndrome Coronavirus Vaccine

• Published in: Antiviral therapy Vol. 12; no. 7; pp. 1107 - 1114
• Main Authors: 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, Dong, Xiao-Ping
• Format: Journal Article
• Language: English
• Published: London International Medical Press 01.01.2007
• Subjects: Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antibodies, Viral - biosynthesis; Antibodies, Viral - immunology; Antiviral agents; Biological and medical sciences; Double-Blind Method; Female; Human viral diseases; Humans; Infectious diseases; Male; Medical sciences; Neutralization Tests; Pharmacology. Drug treatments; SARS Virus - immunology; Severe Acute Respiratory Syndrome - immunology; Severe Acute Respiratory Syndrome - therapy; Severe Acute Respiratory Syndrome - virology; Vaccination; Vaccines, Inactivated - adverse effects; Vaccines, Inactivated - immunology; Viral diseases; Viral diseases of the respiratory system and ent viral diseases; Viral Vaccines - adverse effects; Viral Vaccines - immunology; Human; Lung disease; Respiratory disease; Toxicity; Severe acute respiratory syndrome; Vaccine; Infection; Virus; Prevention; Immunoprophylaxis; Coronavirus; Immunogenicity; Viral disease; Phase I trial; Coronaviridae; Nidovirales
• ISSN: 1359-6535; 2040-2058
• DOI: 10.1177/135965350701200702

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. 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. 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. The inactivated vaccine was safe and well tolerated and can elicit SARS-CoV-specific neutralizing antibodies.