[Edaily Reporter NA EUN-KYUNG ] EuBiologics Co., Ltd.(206650)has confirmed the safety and immunogenicity of its respiratory syncytial virus (RSV) vaccine candidate, “EuRSV,” in a Phase 1 clinical trial in South Korea.

EuBiologics Co., Ltd. announced the results of the domestic Phase 1 clinical trial for EuRSV on the 27th, which involved 100 healthy adults aged 19 to 80. This trial, conducted at Korea University Guro Hospital, was the first-in-human (FIH) clinical trial designed to evaluate the vaccine’s safety and tolerability and to determine the appropriate dosage.

According to the announcement, the adverse events observed following administration of the investigational vaccine were mostly predefined local or systemic reactions, classified as mild (Grade 1) or moderate (Grade 2). No serious adverse drug reactions (SADRs), adverse events of special interest (AESIs), or immediate adverse events were reported, and most adverse events resolved.

Immunogenicity was also confirmed. After the second dose, the test group showed a generally higher immune response compared to the placebo group in terms of anti-RSVF-E2 IgG and RSV-A/RSV-B neutralizing antibodies, and the immune response was found to be maintained up to 52 weeks after the first dose. Levels of IFN-γ and TNF-α, which indicate cellular immune responses, also tended to be higher than in the placebo group, while no marked increase in IL-5 was observed.

However, the company explained that, as this was the first exploratory clinical trial in humans, it did not perform statistical hypothesis testing, and the trial was not designed to verify the difference in efficacy between the treatment and control groups with statistical significance.

EuBiologics Co., Ltd. stated, “Based on the results of this Phase 1 clinical trial, we will establish plans for subsequent clinical trials and continue development.”