Biologic therapeutics company Akston Biosciences Corporation revealed on Saturday that it has dosed the first of 100 subjects under its open-label bridging study of its protein subunit COVID-19 vaccine candidate AKS-452 in India.
Upon approval by India's Drug's Controller General of India (DCGI), Ministry of Health and Family Welfare, the company's open-label bridging study is being conducted by the Supe Heart & Diabetes Hospital and Research Centre in Nashik, India along with four other sites in the state of Maharashtra. The CRO Veeda Clinical Research Ltd is managing the study.
The company added that the AKS-452 is shelf stable for at least six months at room temperatures (up to 25° Celsius or 77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit). The AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely and widely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.
This open-label bridging study will be conducted with 100 healthy volunteers, age 18 and older. The first participants were dosed under the supervision of principal investigator Pravin Dinkar Supe MD, founder of the Supe Heart & Diabetes Hospital and Research Centre. A double-blind Phase II/III study will follow with 1,500 healthy volunteers, age 18 and older, across 12 clinical sites in five states across India.
Under both the studies, healthy volunteers will receive two 90 µg doses 28 days apart. Of the 1,500 participants in the Phase II/III study, 1,150 will receive the two-dose regimen, while the remaining 350 will receive two placebo doses. The first dose will include AKS-452 and an adjuvant, which primes the body's immune response, with the second dose consisting only of AKS-452, concluded the company.
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