Akston Biosciences has dosed the first volunteers in a Phase II/III clinical trial of its low cost, shelf-stable, thermostable protein subunit Covid-19 vaccine, AKS-452, in India.
India’s Central Drugs Standard Control Organization (CDSCO) granted approval for the trial, which was initiated by Veeda Clinical Research in the Indian city of Ahmedabad.
The double-blind, placebo-controlled, multicentre trial intends to enrol 1,500 healthy volunteers aged 18 and above, who will be given two 90µg doses of the vaccine at a gap of 28 days or placebo.
The two-dose regimen comprises a first dose including AKS-452 plus adjuvant that boosts the immune response of the body and the second dose with only AKS-452.
Assessing the safety, tolerability and humoral immunogenicity profile of the vaccine at day 56 following a two-dose series in a combined bridging and a Phase II/III trial is the primary objective.
Dosing is expected to conclude by 15 April and interim data is anticipated to be available in June this year.
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On obtaining the trial results, Akston plans to submit these data for seeking Emergency Use Authorization (EUA).
Akston currently has an AKS-452 licencing, manufacturing and marketing agreement in place with Biolexis, a Strides Group subsidiary.
As per the deal, Biolexis will produce and market the vaccine under the brand name AmbiVax-C in India and more than 130 countries.
Akston Biosciences president and CEO Todd Zion said: “This clinical trial represents an important step in the development of protein-based Covid-19 vaccines.
“We are working closely with Strides Group, which will manufacture AKS-452 at scale so that it can be quickly rolled out after receiving an EUA.”
The latest development comes after the company announced plans to start a Phase II trial of AKS-452 as a booster in the Netherlands.