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January 18, 2022

HDT Bio dose first subjects in Phase I Covid-19 vaccine trial

The trial will enrol 90 subjects to assess the safety, tolerability, and immunogenicity of three dose levels of the vaccine.

HDT Bio dosed the first subjects in a Phase I trial of its Covid-19 vaccine, HDT-301, in Brazil. 

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Using HDT Bio’s lipid nanoparticle ribonucleic acid (RNA)-delivery technology, the vaccine aims to provide easier production and deployment without requiring ultra-low freezers. Furthermore, it needs a lower dose versus existing RNA Covid-19 vaccines.

In September last year, the companies obtained authorisation from Brazil’s National Health Surveillance Agency (Anvisa) to carry out the Phase I trials of HDT-301.

Named ‘Vaccine RNA MCTI-CIMATEC-HDT’, the double-blind, placebo-controlled, dose-ranging trial will be carried out by Senai Cimatec.

It will enrol 90 healthy adult subjects to evaluate HDT-301’s safety, tolerability, and immunogenicity at 1µg, 5µg and 25µg dose levels.

The primary endpoints are tolerability and safety analysed based on the occurrence of adverse events for each dose for 12 months following inoculation. 

The company will also conduct scheduled interim analyses to analyse the immunogenicity of the vaccine.

HDT Bio CEO Steve Reed said: “This clinical trial in Brazil is the second international study to get underway in our efforts to help partners in historically underserved nations fight this pandemic by transferring our unique technology to provide them local control over development, manufacturing and distribution of a Covid-19 RNA vaccine. 

“The first was in India with our partner Gennova Biopharmaceuticals which has moved the vaccine into Phase II and Phase III trials.”

In addition, the company has other collaborations in place for the vaccine, including in China and South Korea. 

The vaccine of HDT Bio will also be analysed in a Phase I trial in the US.

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