Procedures for Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
- The COVID-19 vaccine, developed by the Beijing Institute of Biotechnology and the CanSino Biologics in Tianjin, China, contains a defective adenovirus type-5 vector that consists of a spike glycoprotein of SARS-CoV-2. Administered intramuscularly, this vaccine is in a liquid form with 5 x 10^10 viral particles per 0.5 ml vial.
- Adverse reactions were self-reported by participants daily during the 14 days after vaccination. Blood samples were taken before vaccination and on days 14 and 28. ELISA was used to detect antibody responses against the receptor-binding domain (RBD) and the spike glycoprotein. Neutralizing antibody responses induced by the vaccination were measured using SARS-CoV-2 virus neutralization and pseudovirus neutralization tests (a vesicular stomatitis virus pseudovirus system that also contains a spike glycoprotein). Finally, CD4 and CD8 T-cell responses were detected using enzyme-linked immunospot and flow-cytometry assays.
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Study design and participants for Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Procedures for Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Statistical analysis for Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial