Cellid announced the completion of recruitment and dosing for all subjects in its Phase 3 clinical trial of AdCLD-CoV19-1 OMI, a COVID-19 vaccine specifically targeting the Omicron variant. The trial, conducted across Korea, the Philippines, and Vietnam, involved 4,000 adults aged 19 and older who had completed their last COVID-19 vaccine dose or were at least 16 weeks removed from COVID-19 isolation.
Trial Design and Objectives
The Phase 3 trial is designed to evaluate the safety and immunogenicity of the AdCLD-CoV19-1 OMI vaccine. Cellid plans to analyze the data four weeks after all subjects have been dosed. Based on these results, an interim analysis will be conducted, potentially leading to a conditional marketing authorization application. The company also intends to develop new variant-specific vaccines based on recommendations from the WHO and national health authorities, aiming for national supply through an Emergency Use Authorization (EUA).
Prior Clinical Data
Earlier this month, Cellid finalized the Phase 1/2 top-line results report for its Omicron vaccine. The Phase 2 results indicated that neutralizing antibodies remained stable 52 weeks post-administration, demonstrating long-term immunity and a favorable safety profile with no serious adverse events.
Management Perspective
Cellid CEO Kang Chang-yuil expressed optimism about the trial's progress. "We are very pleased to have completed the dosing of 4,000 subjects in phase 3 and look forward to conducting the interim analysis based on the week four data," Kang said. "We expect positive results in this study as we have seen the vaccine's long-term immune effectiveness and safety in phase 1."
Kang also emphasized the ongoing threat of COVID-19 to high-risk populations and the importance of vaccination. He added, "We are committed to successfully launching our proprietary vaccine and securing vaccine sovereignty. Furthermore, we will continue to research and develop to become a global bio company to respond to future pandemics."
