Massachusetts-based Akston Biosciences on Saturday began mid- to late-stage clinical trials for its COVID-19 vaccine, the company reported. Businesshala, One of many second-generation shots that race for market share as companies race to develop novel jabs and meet growing demand for cheaper, more accessible shots.
Akston said that in a study designed to test its COVID-19 vaccine, AKS-452, a protein-based shot, first participants were exposed to room temperature (25 degrees centigrade or 77 degrees Celsius) for at least six months. Fahrenheit) was kept constant.
The India-based study—a mid-to-late Phase 2/3 trial—will evaluate how effective and safe two doses of the shot are (the first includes an adjuvant, a common vaccine component that enhances the immune response). Given 28 days apart.
Axton will first test the vaccine in 100 healthy volunteers – a small “part of”bridgingTrial to generate data for the local population — and begin a comprehensive study on about 1,500 healthy adults — in January.
Of these, some 1,150 will receive the two-dose vaccine, while the remaining 350 will receive two placebo doses.