India starts trial of US firm’s second-generation Covid vaccine | India News – Times of India

MUMBAI: A clinical study of the US-based Akston Biosciences’ second generation Covid-19 vaccine candidate has kicked off in India.
In an open-label bridging study of `AKS-452’, the protein sub-unit Covid-19 vaccine candidate, the first 100 subjects have been dosed.
The AKS-452 is shelf-stable for at least six months in room temperatures (up to 25° Celsius) and maintains its potency for one month at 37° Celsius, says a release.
India’s Drug Controller General has approved the open-label bridging study being conducted by Supe Heart and Diabetes Hospital and Research Centre in Nashik, along with four other sites in Maharashtra. Ahmedabad-based Veeda Clinical Research is managing the study, it adds.
The AKS-452 is a protein sub-unit vaccine, and does not contain mRNA technology, viral vectors or a weakened SARS-CoV-2 virus.
The first participants were dosed under the supervision of principal investigator Pravin Dinkar Supe, founder of the Nashik hospital. A double-blind Phase II/III study will follow with 1,500 healthy volunteers, aged 18 and above, across 12 clinical sites in five states across India.
“The highly promising results from a previous Phase II trial in the Netherlands warrant moving forward with an open-label bridging study and the Phase II/III clinical trial here in India to help speed a low-cost, temperature-resistant vaccine that can be easily manufactured, transported and stored in economically deprived countries in Africa and Asia,” said Dr Supe.
“These countries lack the infrastructure to transport and store the currently approved vaccines that require ultra-cold conditions.”
“As a second-generation vaccine, AKS-452 has the potential to safeguard the health of populations worldwide against the Covid-19 more easily. Using our proprietary `Fc fusion protein’ platform, AKS-452 is designed to be well tolerated for primary vaccination and boosting when immunity wanes,” said Todd Zion, president and CEO of Akston Biosciences.
The vaccine has been engineered to use standard, low-cost, antibody manufacturing techniques such that a single production line would be capable of producing over one billion doses per year, the release said.

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