Cellid Receives Approval for Phase 1 and 2 Clinical Trials of COVID-19 Omicron-Specific Vaccine

[Asia Economy Reporter Hyunseok Yoo] Cellid announced on the 4th that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 1 and 2 trial plans of the COVID-19 vaccine ‘AdCLD-CoV19-1 OMI’.

‘AdCLD-CoV19-1 OMI’, a COVID-19 vaccine developed using Cellid’s proprietary platform technology, is a vaccine specialized for the globally spreading Omicron variant. It is being developed for booster dose use. Through animal experiments, Cellid observed a significant increase in Omicron-specific neutralizing antibody titers following booster administration of ‘AdCLD-CoV19-1 OMI’. The company plans to rapidly conduct the phase 1 and 2 clinical trials to once again demonstrate the excellent preclinical trial results.

The phase 1 and 2 clinical trials of ‘AdCLD-CoV19-1 OMI’ will be conducted on adults aged 19 and older who have completed the primary vaccination series of all authorized COVID-19 vaccines, and for whom at least 16 weeks but less than 48 weeks have passed since the last vaccination or release from isolation due to COVID-19 diagnosis. In phase 1, safety will be evaluated by administering a booster dose of ‘AdCLD-CoV19-1 OMI’ to 20 participants, followed by phase 2, where safety and immunogenicity of the booster dose will be assessed in 300 participants.

The clinical trial samples of the Omicron-specific vaccine ‘AdCLD-CoV19-1 OMI’ will be produced at the Seongnam GMP Center. Unlike previous COVID-19 vaccine clinical samples that Cellid outsourced for production, the company plans to prioritize production of the ‘AdCLD-CoV19-1 OMI’ clinical samples at its own GMP facility.