Japanese company Shionogi has commenced Phase I/II clinical trial of a prophylactic Covid-19 vaccine candidate and administered the first dose.
The recombinant protein vaccine contains a purified target antigen protein, which is produced using genetic information from the SARS-CoV-2 virus.
Since April, Shionogi has been working on the discovery and development of the recombinant protein vaccine (code No. S-268019), using its subsidiary UMN Pharma’s Baculovirus Expression Vector System technology.
The randomised, double-blind and placebo-controlled study will test multiple doses of the antigen protein and adjuvant in combination.
It has enrolled over 200 Japanese adult participants.
The safety, tolerability and immunogenicity of two doses of the vaccine, given three weeks apart, will be evaluated to determine the optimal dose.
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Flash reports from the trial are anticipated to be obtained from the February end next year.
Based on these results and the global pandemic situation, the company will hold discussions with the Japanese Ministry of Health, Labor and Welfare, Pharmaceuticals and Medical Devices Agency (PMDA) and other organisations on further clinical studies.
In a separate development, Medigen Vaccine Biologics has sought permission from Taiwan’s Food and Drug Administration (FDA) to initiate Phase II clinical trials of its Covid-19 vaccine.
Focus Taiwan quoted Medigen as saying that all subjects in its Phase I trial had received the two doses of the vaccine, allowing researchers to obtain results on its safety and ability to elicit an immune response.
The company intends to test the vaccine’s efficacy on 3,700 volunteers.
Medigen’s recombinant protein vaccine, MVC-COV1901 is developed jointly with the US National Institutes of Health (NIH)
Medigen is the third firm in Taiwan to seek approval for testing the efficacy of its product on a larger scale, following Adimmune and United Biomedical.
The company received funding worth NT$472.19m ($16.78m) from Taiwan’s government to develop the vaccine.