Alliance for Pandemic Preparedness

May 26, 2020

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

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  • A phase 1 trial of an adenovirus type-5 vectored COVID-19 vaccine expressing the spike glycoprotein of SARS-CoV-2 was conducted in Wuhan, China (dose-escalation, single-center, open-label, non-randomized). Thirty-six participants received each dose of the vaccine (low, middle, high). At least one adverse reaction within 7 days of vaccination was reported in 83% of participants in the low-dose group, 83% in the middle-dose group, and 75% in the high-dose group, including pain (54%), fever (46%), fatigue (44%), headache (39%) and muscle pain (17%). No serious adverse events were noted within 28 days post-vaccination.  
  • ELISA antibodies and neutralizing antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination.  

Zhu et al. (May 2020). 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. Lancet. https://doi.org/10.1016/S0140-6736(20)31208-3