Vaccine maker Adimmune Corp (國光生技) last week applied to the Food and Drug Administration (FDA) to run phase I human clinical trials of one of its COVID-19 vaccine candidates, the company said on Monday.
Last month, in the first stage of animal testing, one antigen prototype — four were designed to fight the virus based on the company’s recombinant protein technology — was found to inhibit growth of the novel coronavirus, the company said.
Although the candidate has yet to undergo full animal testing, Adimmune applied to use it in human trials under the FDA’s fast-track program for emergency use authorizations, which is intended to speed up the development of a treatment for COVID-19, it said.
The first stage of animal testing aimed to find out if mice injected with the antigen could generate antibodies strong enough to curb viral replication, while the second stage of testing aims to determine if the antigen would endanger the mice, Adimmune spokesman Pan Fei (潘飛) told the Taipei Times by telephone.
“The second stage will take six months and we just began the testing last month, so it would be too late if we waited for the outcome before moving on to human trials,” Pan added.
Adimmune hopes to start phase I human clinical trials by August, Pan said, adding that about 100 healthy volunteers are to be injected with the vaccine to see if the antigen is safe.
The protocol has not been finalized and must be approved by the FDA, he said.
The company had discussions with the regulator before submitting the application, but does not know how long the regulator’s review might take, Pan added.
If the phase I trials go smoothly, Adimmune plans to apply to run phase II human clinical trials by the end of this year, Pan said.
“We need to test the vaccine candidate’s effectiveness in double-blind phase II clinical trials. We would inject the antigen into volunteers and see if they can be infected in an environment exposed to the novel coronavirus,” he added.
However, as the outbreak is easing in Taiwan, phase II trials might need to be conducted in other countries, Pan said, adding that the firm would discuss the matter with foreign regulators.
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