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. 

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.