Cellid applies for Phase 3 clinical trials in S.Korea for COVID-19 vaccine
Min Su Han
May 23, 2023 (Gmt+09:00)
South Korean bio-venture Cellid Co. announced on Tuesday that it has applied for the clinical Phase 3 trial of the COVID-19 Omicron variant-specific vaccine, "AdCLD-CoV19-1 OMI," to the Ministry of Food and Drug Safety.
The Phase 3 trial will involve a target group of 4,000 adults aged 19 or older who have completed the primary COVID-19 vaccination or have been released from quarantine after a minimum of 16 weeks since COVID-19 infection. The trial will evaluate the immunogenicity and safety of additional doses of AdCLD-CoV19-1 OMI using a multinational, observer-blinded, randomized and active-controlled design.
The comparator vaccine will be Pfizer's "Comirnaty bivalent." The comparator vaccine is expected to be secured through government cooperation.
Cellid reported that in earlier Phase 1 and 2 trials, they observed a significant increase in Omicron-specific neutralizing antibody titers following the administration of AdCLD-CoV19-1 OMI.
Cellid also stated that they are accelerating the development of a long-lasting and globally applicable universal COVID-19 multi-valent vaccine. "Even during the COVID-19 endemic, there are severe cases and deaths caused by COVID-19 variants. The demand for COVID-19 variant-specific vaccines will continue worldwide," a company official said.