Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine

Corresponding authors: Fengcai Zhu, Wei Chen 

Affiliations: Beijing Institute of Biotechnology, Beijing, China; NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China; China National Institute for Food and Drug Control, Beijing, China; Hubei Provincial Center for Disease Control and Prevention, Wuhan, China; Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China; CanSino Biologics, Tianjin, China; Clinical Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Shanghai Canming Medical Technology, Shanghai, China.

Publication date: this article was published online on May 22, 2020

DOI: https://doi.org/10.1016/S0140-6736(20)31208-3

Highlights

In order to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain. The researchers did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. The findings showed that most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination.

Nomination Reasons

The data presented in this article show that the Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Those findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.

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