AnGes, Inc. announced the results of a series of clinical trials conducted since 2020 on the novel coronavirus (COVID-19) DNA vaccine as follows. In each of the clinical trials, the safety of the vaccine was confirmed. As for the efficacy, although cellular immune response was confirmed to some extent, humoral immune response, a primary endpoint, observed was not as much as expected. AnGes will hereafter focus on a clinical trial of a high-concentration (high-conc.) vaccine, which already started in August 2021, as an effort to further improve efficacy. Phase 1/2 Clinical Trial of COVID-19 DNA Vaccine (1) Overview. Study design: An open-label, non-controlled study to evaluate the safety and immunogenicity of the intramuscular DNA vaccine injection in healthy adult volunteers. Target enrollment: 30 participants. Administration: Intramuscular injection. Results: No safety issues were observed. Although induction of humoral immune response was observed in some subjects as efficacy, it was not as much as expected. AnGes decided to proceed further development with an improved vaccine. Phase 1/2 clinical trial of COVID-19 DNA vaccine (2) Overview. Study design: An open-label, non-controlled study to evaluate the safety and immunogenicity of the intramuscular DNA vaccine injection in healthy adult volunteers. Target enrollment: 30 participants. Administration: Intramuscular injection. Results: There were no safety issues. The company confirmed cellular immune response to some extent as efficacy. Although induction of humoral immune response was observed in some subjects, AnGes judged it is necessary to confirm this in a larger-scale trial. Phase 2/3 Clinical Trial of COVID-19 DNA Vaccine Overview. Study design: A randomized, double-blind, placebo-controlled study to evaluate the safety and immunogenicity of the intramuscular DNA vaccine injection in healthy adult volunteers. Target enrollment: 500 participants. Administration: Intramuscular injection Results: There were no safety issues. The company confirmed cellular immune response to some extent as efficacy. Although induction of humoral immune response was observed in some subjects, it was not as much as expected, leading AnGes to address further improvement in efficacy. Phase 1/2 Clinical Trial of COVID-19 High-Conc. DNA Vaccine. Study design: A randomized, open-label study to evaluate the safety and immunogenicity of the high-conc. DNA vaccine in healthy adult volunteers. Target enrollment: 400 participants.