Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial.
Shengli Xia: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Kai Duan: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Yuntao Zhang: Clinical Medical Center, China National Biotec Group Company Limited, Beijing, China.
Xiaoqing Zeng: Department of Infectious Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Dongyang Zhao: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Huajun Zhang: Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China.
Zhiqiang Xie: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Xinguo Li: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Cheng Peng: Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China.
Wei Zhang: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Yunkai Yang: Clinical Medical Center, China National Biotec Group Company Limited, Beijing, China.
Wei Chen: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Xiaoxiao Gao: Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China.
Wangyang You: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Xuewei Wang: Clinical Medical Center, China National Biotec Group Company Limited, Beijing, China.
Zejun Wang: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Zhengli Shi: Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China.
Yanxia Wang: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Xuqin Yang: Clinical Medical Center, China National Biotec Group Company Limited, Beijing, China.
Qingliang Li: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Lili Huang: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Qian Wang: Clinical Medical Center, China National Biotec Group Company Limited, Beijing, China.
Jia Lu: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Yongli Yang: Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, China.
Jing Guo: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Wei Zhou: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Xin Wan: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Cong Wu: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Wenhui Wang: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Shihe Huang: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Jianhui Du: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Xuanxuan Nian: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Tao Deng: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Zhiming Yuan: Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China.
Shuo Shen: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Wanshen Guo: Vaccine Clinical Research Center, Henan Center for Disease Control and Prevention, Zhengzhou, China.
Jia Liu: Department of Infectious Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Xiaoming Yang: National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, China.
Safe and effective vaccines against SARS-CoV-2 for children are urgently needed. Here we aimed to assess the safety and immunogenicity of an inactivated COVID-19 vaccine candidate, WIBP-CorV, in participants aged 3-17 years. A randomized, double-blind, placebo-controlled, phase 1/2 clinical trial was conducted in Henan Province, China, in healthy children aged 3-17 years. 240 participants in phase 1 trial and 576 participants in phase 2 trial were randomly assigned to vaccine or control with an age de-escalation in three cohorts (3-5, 6-12 and 13-17 years) and dose-escalation in three groups (2.5, 5.0 and 10.0μg/dose), and received 3 intramuscular injections at day 0, 28, and 56. WIBP-CorV showed a promising safety profile with approximately 17% adverse reactions within 30 days after injection and no grade 3 or worse adverse events. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting. The geometric mean titers of neutralizing antibody ranged from 102.2 to 1065.5 in vaccinated participants at 28 days after the third vaccination, and maintained at a range of 14.3 to 218.2 at day 180 after the third vaccination. WIBP-CorV elicited significantly higher titers of neutralizing antibody in the cohort aged 3-5 years than the other two cohorts. There were no detectable antibody responses in all alum-only groups. Taken together, our data demonstrate that WIBP-CorV is safe and well tolerated at all tested doses in participants aged 3-17 years, and elicited robust humoral responses against SARS-CoV-2 lasted for at least 6 months after the third vaccination. This study is ongoing and is registered with www.chictr.org.cn, ChiCTR2000031809.
