Study protocol for a randomized, open-label, non-controlled Phase I/II Study to assess safety and immunogenicity of twice or three times dosing of intramuscular COVID-19 DNA vaccine in healthy adults

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There is currently an outbreak of respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and many vaccines have been rapidly developed using different technologies. We have challenged to develop DNA vaccines for SARS-CoV-2. After the basic and preclinical experiments, AnGes, Inc. conducted a randomized, open-label, non-controlled Phase I/II Study to assess safety and immunogenicity of intramuscular DNA vaccine (AG0302-COVID19) in Osaka University Hospital. Thirty healthy volunteers, male or female, aged 20–65, will be randomized to one of the following three groups, 1) 2.0 mg of AG0302-COVID19 twice at 2-week intervals, 2) 2.0 mg of AG0302-COVID19 twice at 4-week intervals, 3) 2.0 mg of AG0302-COVID19 three times at 2-week intervals. This study will assess the safety and immunogenicity of AG0302-COVID19. The primary endpoint about the safety and tolerability has been assessed by the incidence of treatment emergent adverse events from week 1 through week 9, and frequency and severity of each adverse event, including solicited local and systemic adverse events through 8 weeks after the first vaccination. The immunogenicity has been also assessed by the change in geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike glycoprotein specific antibody. This study has been registered at the ClinicalTrials.gov.as NCT04527081.