[Edaily Reporter NA EUN-KYUNG ] EuBiologics Co., Ltd.(206650)announced on the 27th that it has received the Clinical Study Report (CSR) for the Phase 1 clinical trial of “EuRSV,” a respiratory syncytial virus (RSV) vaccine it is developing in-house, and has confirmed its safety and immunogenicity.

This clinical trial was conducted in South Korea with 100 healthy adults aged 19 to 80 using a randomized, observer-blind, placebo-controlled design. The study evaluated low- and high-dose formulations of the RSV-1 (including QS-21) and RSV-2 (excluding QS-21) vaccine candidates. Participants received two doses administered four weeks apart, followed by a safety and immunogenicity follow-up period of up to 52 weeks.

The clinical results showed no reports of serious adverse drug reactions (SADRs), adverse events of special interest (AESIs), or immediate adverse events related to the vaccine. Most adverse reactions were mild to moderate in severity, including pain and tenderness at the injection site, fatigue, headache, and muscle pain.

Immunogenicity assessments showed increases in RSV-specific IgG antibodies and RSV-A and RSV-B neutralizing antibodies, and cellular immune responses (IFN-γ, TNF-α) were also confirmed.

This results report also highlighted differences in the immunological characteristics of the two candidate substances. The high-dose RSV-2 formulation exhibited the highest neutralizing antibody response, while RSV-1 demonstrated a relatively strong cellular immune response, confirming the distinct characteristics of each platform.

Based on these results, EuBiologics Co., Ltd. plans to select the optimal candidate and dosage and proceed with a Phase 2 clinical trial.

An official from EuBiologics Co., Ltd. stated, “Through this Phase 1 clinical trial, we have confirmed the safety and immunogenicity of EuRSV,” adding, “We will pursue entry into the global RSV vaccine market based on our next-generation liposome vaccine platform.”