The Hyderabad-based Bharat Biotech has begun a Phase I human clinical trial of the indigenously developed chikungunya vaccine three months ago. The vaccine uses a killed virus.
The Phase I trial will test mainly for safety and the ability of the vaccine to provoke an immune response in the body. The higher the immune response produced in response to the vaccine the better will the vaccine’s ability to prevent an infection. The trial will enrol 60 volunteers, and some will get the vaccine while the rest will get a dummy (placebo). The volunteers will be randomly assigned to receive either the vaccine or a placebo.
“We got promising results during animal trials,” says Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech. “The animal trials were carried out in mice, rats and rabbits.”
“Volunteers will get three doses of the vaccine — day 0 [day of enrolment], 28 and 56 days. Some have already got the second dose. We are yet to recruit all 60 volunteers,” he says.
Bharat Biotech developed the vaccine using the virus from an Indian epidemic. “The candidate vaccine being tested was able to cross neutralize the Asian virus isolated in 1963 and successive Indian epidemics caused by the East Central South African viruses since 2006,” says a release.
Bharat Biotech filed a patent in 2007 for the vaccine drawing priority from 2006, and followed up with a second patent in 2011. Patents have been granted in the U.S., Europe, China, Indonesia, South Africa and is in national phase in several other countries.