Jinwon Life Sciences Publishes Phase 1 Clinical Trial Results of 'COVID-19 DNA Vaccine' in International Journal

[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 4th that it published the Phase 1 clinical trial results on the safety and immunogenicity of the COVID-19 DNA vaccine GLS-5310 using its self-developed suction intradermal injector GeneDerm in the International Journal of Infectious Diseases, the official journal of the International Society for Infectious Diseases (ISID).

The Phase 1 study was designed with three groups of 15 participants each according to dose and dosing interval. Group 1a received 0.6mg of GLS-5310 at weeks 0 and 8, group 1b received 1.2mg at weeks 0 and 8, and group 1c received 1.2mg at weeks 0 and 12, followed by 48 weeks of follow-up observation.

The company stated, "The Phase 1 results showed excellent tolerability of GLS-5310 with no serious vaccine-related adverse events, and it induced high levels of antibody and T-cell responses that lasted for one year. The antibody seroconversion rate was 95.5% at 4 weeks post-vaccination and was sustained for 48 weeks."

They added, "The T-cell response induced by GLS-5310 via intradermal injection using GeneDerm was approximately 15 to 20 times greater than that of all other vaccines, including mRNA and adenovirus vaccines. This is the first clinical case applying the self-developed suction device GeneDerm to a DNA vaccine."

Preclinical studies showed that administering GLS-5310 with GeneDerm elicited superior immune responses in animals compared to DNA vaccines delivered by other devices, without causing trauma to skin tissue. The company said, "GeneDerm is a next-generation medical device for DNA vaccine administration that has demonstrated superior efficacy compared to other delivery devices."

Park Younggeun, CEO of GeneOne Life Science, emphasized, "These clinical results demonstrate the development potential of the differentiated COVID-19 DNA vaccine GLS-5310 in the COVID endemic era and the clinical applicability of GeneDerm for DNA vaccine delivery. In a situation where sustained vaccine efficacy is important, the stable immune response and efficacy shown by GLS-5310 over one year have very significant implications as a COVID-19 booster vaccine."