EuBiologics completes Phase 1 trial of RSV vaccine EuRSV, confirming safety and immunogenicity

EuBiologics said Monday it had received the clinical study report for the domestic Phase 1 trial of EuRSV, its respiratory syncytial virus (RSV) preventive vaccine, confirming the drug's safety and immunogenicity.

The trial enrolled 100 healthy adults between the ages of 19 and 80 and was conducted using a randomized, observer-blinded, placebo-controlled design. Researchers evaluated two vaccine candidates — RSV-1 and RSV-2 — across different dose levels, with participants receiving two injections four weeks apart and then monitored for 52 weeks.

EuRSV showed strong safety results, with only mild to moderate transient reactions reported and no serious adverse drug reactions or adverse events of special interest. Immunogenicity assessments showed significant increases in RSV-specific IgG antibodies and neutralizing antibodies against both RSV type A and type B compared with the placebo group, with cellular immune responses effectively induced as well.

The Phase 1 validation of safety and efficacy for a vaccine built on EuBiologics' proprietary premium adjuvant platform technology has particularly strengthened prospects for expanding the platform into a broader pipeline of infectious disease vaccines and for potential global technology licensing deals.

Building on the Phase 1 results, EuBiologics said it will finalize the optimal dose and vaccine candidate before launching a larger Phase 2 trial in the near future.

"Demonstrating EuRSV's safety and immunogenicity through this trial is an important milestone in our push into the global market," a company official said. "We will accelerate the development of competitive vaccines based on our proprietary platform technology."