Mumbai: A clinical study of the second generation Covid-19 vaccine candidate based in the US has begun in India.
In an open bridging label study of ‘AKS-452’, Candidates for the Covid-19 sub-unit vaccine, the first 100 subjects have been doses.
AKS-452 is stable on the shelf of at least six months at room temperature (up to 25 ° Celsius) and maintains its potential for one month at 37 ° Celsius, said liberation.
General Indian drug controllers have agreed to an open bridging label study conducted by Supe Heart and Diabetes Hospital and Research Center in Nashik, along with four other sites in Maharashtra.
Veeda-based clinical research based on Ahmedabad manages research, he added.
AKS-452 is a sub-unit protein vaccine, and does not contain MRNA technology, virus vector or the weakening SARS-COV virus.
The first participant dose under the supervision of Pravin’s main investigation of Dinkar Supe, the founder of the Nashik Hospital.
Double Blind II / III Studies will follow with 1,500 healthy volunteers, 18 years and above, in 12 clinical sites in five states throughout India.
“Very promising results from previous Phase II experiments in the Netherlands guarantee moving forward with open bridging label studies and clinical testing phase II / III here in India to help accelerate temperature resistant vaccines that can be easily produced, transported and stored in countries which is less efficient in Africa and Asia, “said Dr.
Supe.
“These countries do not have infrastructure to transport and store vaccines that are approved today requires ultra-cold conditions.” “As a second generation vaccine, AKS-452 has the potential to maintain the health of the population around the world against Covid-19 more easily.
Using the proprietary platform` FC Fusion Protein ‘, AKS-452 is designed to be well tolerated for primary vaccination and improve when immunity Decreases, “said Todd Zion, President and CEO of Biosciences Akston.
Vaccines have been designed to use standard antibody making techniques, low-cost, so that a single production line will be able to produce more than one billion doses per year, the release said.