Alliance for Pandemic Preparedness

June 2, 2021

Safety and Immunogenicity of a Recombinant DNA COVID-19 Vaccine Containing the Coding Regions of the Spike and Nucleocapsid Proteins Preliminary Results from an Open-Label Phase 1 Trial in Healthy Adults Aged 19-55 Years

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  • [Pre-print, not peer-reviewed] An open-label phase 1 trial in Korea for the recombinant COVID-19 DNA vaccine candidates GX-19 and GX-19N (Genexine, Inc.) (n=61) found that geometric mean titers (GMTs) of anti-SARS-CoV-2 antibodies elicited by vaccination were lower than convalescent sera (although higher than pre-vaccination sera). GX-19N-elicited T-cell responses were stronger than GX-19 and were similar in magnitude to T-cell responses from convalescent individuals. Additionally, GX-19N induced spike and nucleocapsid-specific responses containing epitopes also identified in SARS-CoV-2 variants of concern. Solicited adverse events were reported in 52% of participants, all but one of which were mild.

Ahn et al. (June 1, 2021). Safety and Immunogenicity of a Recombinant DNA COVID-19 Vaccine Containing the Coding Regions of the Spike and Nucleocapsid Proteins Preliminary Results from an Open-Label Phase 1 Trial in Healthy Adults Aged 19-55 Years. Pre-print downloaded Jun 2 from https://doi.org/10.1101/2021.05.26.21257700