Genexine Confirms Safety and Immunogenicity in Phase 1 Clinical Trial of COVID-19 Vaccine

MedRxiv Announces Phase 1 Clinical Trial Results of 'GX-19N'

[Asia Economy Reporter Kim Ji-hee] Genexine announced the Phase 1 clinical trial results of the COVID-19 vaccine candidate 'GX-19N' on the medical preprint site medrxiv on the 2nd. Genexine conducted the Phase 1 trial by administering 3 mg of GX-19N twice at 4-week intervals to 21 healthy adults aged 19 to 55.

This paper particularly emphasized the vaccine's safety. After administering 3 mg of GX-19N, adverse drug reactions occurred in 10 participants, but all were mild at Grade 1 level, and the systemic adverse reaction rate was below 10% in all categories. No participants showed severe adverse reactions or discontinued the trial due to side effects. Side effects did not increase after the second dose.

In terms of immunogenicity, spike and RBD protein-binding antibodies increased more than fourfold in about 81% of participants. Neutralizing antibodies also showed a significant increase compared to before administration. Additionally, at least 18 out of 20 clinical participants exhibited T cell immune responses to spike protein and nucleocapsid protein equal to or greater than those of recovered patients.

Genexine also investigated whether nucleocapsid-specific T cells induced after GX-19N vaccination respond to variants from the UK (B.1.1.7), South Africa (N.1.351), and Brazil (P.1). The investigation found that the amino acid sequences identified in COVID-19 variants were identical to the amino acid sequences recognized by T cells found in the GX-19N vaccinated group. Accordingly, Genexine expects that the nucleocapsid-specific T cell response induced by GX-19N could act against future emerging COVID-19 variants.

Sung Young-chul, CEO of Genexine, stated, "The biggest feature of GX-19N is the addition of the nucleocapsid antigen, which has very high sequence conservation." He added, "Having reconfirmed the safety and broad, strong T cell response of GX-19N through this trial, we will rapidly proceed with global Phase 2 and 3 clinical trials based on these results."

This content was produced with the assistance of AI translation services.