Jinwon Life Sciences Completes Enrollment of Clinical Trial Participants for COVID-19 DNA Vaccine Booster Shot

[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 8th that the registration of all 69 participants for the Phase 1 clinical trial of the COVID-19 DNA vaccine GLS-5310 booster shot currently underway in the United States has been completed.

This clinical trial is a double-blind, placebo-controlled study evaluating the safety, tolerability, and immunogenicity of GLS-5310 administered intradermally (ID) using the self-developed suction-type injector Gene-Derm, or a combination of intradermal (ID) and intranasal (IN) administration, in individuals who have completed the primary series of existing COVID-19 vaccines.

A GeneOne Life Science official stated, "In a separate study with one year of follow-up, we found that GLS-5310 continuously induces antibody and T cell responses," and added, "When GLS-5310 was administered intradermally using the self-developed simple suction pressure injector Gene-Derm, it induced T cell responses up to 15 to 30 times higher than all other vaccines, including mRNA vaccines and adenovirus vaccines."

Furthermore, they said, "Six to eight months after GLS-5310 administration, mRNA vaccine inoculation showed a stronger immune response compared to the effects of homologous and heterologous COVID-19 booster vaccines previously reported," and added, "In studies related to booster vaccines, the immune response following the booster was similar regardless of the sequence of the primary vaccine type and the booster vaccine type."

Park Younggeun, CEO of GeneOne Life Science, said, "The fact that the immune response of GLS-5310, characterized by very high T cell responses, lasted for one year means that GLS-5310 is optimal for use as a COVID-19 booster vaccine," and added, "We plan to begin an interim analysis one month after the completion of dosing for the booster shot clinical trial participants."

He continued, "GLS-5310 is produced by VGXI, a subsidiary located in Texas, USA, and the suction-type intradermal injector Gene-Derm used for vaccine administration is a next-generation DNA vaccine delivery medical device proven to have advantages such as ease of administration, cost competitiveness, and minimal injection site damage, as well as efficacy."

Meanwhile, GeneOne Life Science previously reported that in COVID-19 challenge infection models using hamsters and genetically modified mice, GLS-5310 not only prevented infection by the wild-type and Beta variant of the COVID-19 virus but also demonstrated preventive effects without high levels of neutralizing antibodies against highly vaccine-resistant Beta and Omicron variants, thereby proving the broad immunogenicity of GLS-5310 when administered intradermally and intranasally.