Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: A dose-escalation, open-label, non-randomized, first-in-human trial
The Lancet — Zhu FC, Li YH, Guan XH, et al. | June 15, 2020
Researchers examined 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 via performing a dose-escalation, single-center, open-label, non-randomized, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Among 108 recruited participants (51% male, 49% female; mean age 36·3 years), 36 received low dose, 36 received middle dose, or 36 received high dose of the vaccine. Per observations, the participants well tolerated the Ad5 vectored COVID-19 vaccine; the vaccine was immunogenic at 28 days post-vaccination. In healthy adults, humoral responses against SARS-CoV-2 peaked at day 28 post vaccination; they noted rapid specific T-cell responses from day 14 post vaccination. They support undertaking further investigation of the Ad5 vectored COVID-19 vaccine.
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