Cellid, a developer of cancer immunotherapy and Covid-19 vaccines, said Tuesday that it has begun dosing subjects in a phase 3 clinical trial of its Covid-19 Omicron-specific vaccine, Adcld-cov19-1 OMI, at Korea University Ansan Hospital in Gyeonggi Province and Dong-A University Hospital in Busan.
The phase 3 trial aims to enroll 4,000 healthy volunteers aged 19 years or older who have completed their last dose of a Covid-19 vaccine or are at least 16 weeks post-quarantine from Covid-19 infection.
The study will evaluate the safety and immunogenicity of Adcld-cov19-1 OMI against Pfizer's Covid-19 vaccine, Comirnaty 2 Injection.
Cellid will administer Adcld-cov19-1 OMI at 13 clinical sites in Korea, including Korea University Ansan Hospital and Dong-A University Hospital.
Additionally, the company will conduct clinical trials in the Philippines and Vietnam to support global commercialization, with an Investigational New Drug (IND) application for the phase 3 Adcld-cov19-1 OMI clinical trial currently undergoing review for approval in these countries.
The results from the phase 2 clinical trials conducted thus far are anticipated to demonstrate safety and efficacy through comparative evaluations with vaccines from global pharmaceutical companies.
A Cellid official expressed confidence in the successful execution of the phase 3 clinical trials.
An analysis of a phase 2 trial of Adcld-cov19-1 OMI, published in July, revealed a notable increase of 10.08-fold in neutralizing antibodies in subjects with no history of Covid-19 infection at four weeks post-vaccination compared to pre-vaccination.