Celid announced on the 27th that it had applied for a Phase 1/2 clinical trial plan (IND) of AdCLD-CoV19-1 OMI, a COVID-19 preventive vaccine, to the Ministry of Food and Drug Safety.
Previously, on the 12th, Celid was a multicenter to confirm the safety and immunogenicity of the COVID-19 preventive vaccine AdCLD-CoV19-1 OMI booster dose for adult volunteers 19 years of age or older who completed vaccination against SARS-CoV-2. , a double-blind, randomized, placebo-controlled Phase 1/2 clinical trial plan (IND) was submitted, but it was changed and re-submitted on the 27th.
AdCLD-CoV19-1 OMI is a vaccine in which the SARS-CoV-2 Omicron variant spike protein gene is inserted into a replication-defective adenovirus type 5/35 vector.
The title of the clinical trial for which this IND was submitted is a multicenter, double-blind, randomized, placebo-controlled trial to confirm the safety and immunogenicity of the COVID-19 preventive vaccine AdCLD-CoV19-1 OMI booster dose in adult volunteers 19 years of age or older. This is a phase 1/2 clinical trial.
In other words, it was limited to adult volunteers over the age of 19 who had completed vaccination against SARS-CoV-2, but the target was greatly expanded to adult volunteers.
In addition, the size of the clinical trial subjects was reduced from 20 patients in phase 1 and 360 patients in phase 2 to 20 patients in phase 1 and 300 patients in phase 2.
The target disease (indication) is the prevention of COVID-19 by the SARS-CoV-2 Omicron variant, and clinical trials are scheduled to be conducted at multiple institutions, including Korea University Guro Hospital.
Cellid said, “AdCLD-CoV19-1 OMI penetrates into antigen-presenting cells of the human body and produces a large amount of S protein antigen of the COVID-19 micron mutant virus, thereby activating T cells and B cells, and long-term memory immunity against the antigen. Because it is induced, it is expected to have a preventive effect against the omicron-mutated virus.”
He continued, “We will proceed with this clinical trial to confirm the safety and evaluate the immunogenicity after additional vaccination of the in-house developed vaccine.” “15 months from the date of approval of the IRB It will take about approx.)
As for the reduction in the size of the clinical trial subjects and the expansion of the target group compared to the original plan, he explained, “This is to conduct a rapid and realistic clinical trial in an endemic situation such as an increase in the number of infected people due to the spread of Omicron mutant infection.”
On the other hand, he added that the probability of receiving final approval for a clinical trial drug is around 10%, and there is a possibility that unexpected results may occur during the clinical trial process, or the commercialization plan may be changed or abandoned.