Oncology immunotherapies company HDT Bio Corp announced on Tuesday that it dosed the first healthy volunteer under its US Phase 1 clinical trial of its next generation COVID-19 RNA vaccine, HDT-301, funded by National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).
The company stated that the clinical trials in 60 healthy volunteers will evaluate the safety and efficacy (including antibody and cellular responses) of its RNA vaccine at dose levels much lower than currently approved RNA vaccines. The other metrics of focus will include magnitude and longevity of antibody and T-cell responses to the injections.
Under the company trial, the vaccinated subjects will receive either one or two injections, while the unvaccinated subjects will receive two injections. Dose levels under investigation are 1, 5, and 25 μg (microgram).
According to the company, the HDT-301 vaccine targets the Beta variant of SARS-CoV-2 and has a demonstrated ability to provide broad protection against multiple variants of the virus that causes COVID-19 and unique cellular immunity compared to existing mRNA vaccines.
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