Cellid Begins Phase 3 Clinical Trial Dosing for COVID-19 Omicron Vaccine

Vaccine development specialist Cellid announced on the 27th that it has started administering the ‘AdCLD-COVID19-1 OMI,’ a COVID-19 Omicron variant-specific vaccine currently under development, to Phase 3 clinical trial participants at Korea University Ansan Hospital and Dong-A University Hospital.

A researcher is conducting research related to the development of a COVID-19 vaccine at the Cellid Cell Gene Therapy GMP Center in Seongnam-si, Gyeonggi Province.
[Image source=Yonhap News]

This Phase 3 clinical trial is being conducted on 4,000 healthy domestic and international adult volunteers aged 19 and older, who have completed their last COVID-19 vaccination or have been released from COVID-19 isolation for at least 16 weeks. Pfizer’s ‘Comirnaty 2 weeks’ is being used as the control drug to evaluate the safety and immunogenicity of the COVID-19 vaccine under development.

The clinical trial is being conducted at 13 domestic clinical sites, starting with Korea University Ansan Hospital and Dong-A University Hospital, followed by Korea University Guro Hospital, Gangnam Severance Hospital, Gachon University Gil Medical Center, Chonnam National University Hospital, and others.

Cellid also plans to conduct clinical trials in the Philippines and Vietnam to advance global commercialization. The Phase 3 clinical trial application (IND) has been submitted to the Philippine Food and Drug Administration, and procedures for IND application are underway in Vietnam as well.

According to the interim analysis results of the Phase 2 clinical trial announced in July, neutralizing antibodies in subjects without a history of COVID-19 infection increased tenfold at 4 weeks after vaccination compared to before vaccination.

A Cellid representative stated, “Based on the interim results of the Phase 2 clinical trial of the Omicron-specific vaccine conducted so far, we expect to demonstrate superior safety and efficacy in comparative evaluations with global pharmaceutical company vaccines.”