Cellid applies for Phase 3 clinical trials in S.Korea for COVID-19 vaccine

The company submits clinical trial plan for Omicron variant-specific vaccine to the Ministry of Food and Drug Safety

Cellid applies for Phase 3 clinical trials in S.Korea for COVID-19 vaccine
Min Su Han 1
2023-05-23 17:54:09 hms@hankyung.com
Bio & Pharma

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.

Write to Min Su Han at hms@hankyung.com
#Cellid #Omicron variant-specific vaccine #AdCLD-CoV19-1 OMI #Omicron-specific neutralizing antibody titers #multi-valent vaccine

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