HYDERABAD: Indian vaccines manufacturer Bharat Biotech has on Monday announced that the phase-1 first-in-human clinical trials of its indigenously developed Chikungunya vaccine are underway in the country to evaluate its safety, tolerability and immunogenicity.
In a statement, the company said “the placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen.”
The Hyderabad headquartered biotechnology firm claims to have developed the vaccine using an isolate of the virus from Indian epidemic. The company said the inactivated virus vaccine developed by the in-house R&D was found to be safe and immunogenic in pre-clinical animal testing.
India’s drug regulator, Drug Controller General of India (DCGI), has approved the candidate vaccine for phase-1 clinical trials after successful completion of the product development and pre-clinical testing, the company said.
“Chikungunya is one among the modern day most dreaded virus, and developing an efficient vaccine to prevent it means a lot to people at risk for the infection,” says Bharat Biotech’s chairman and managing director Dr Krishna Ella. “Our pre-clinical studies were promising and we hope that the first-in-human clinical trials successfully meets with the clinical endpoints.”
Bharat Biotech plans to advance the vaccine into phase-II and phase-III clinical development if phase-1 clinical testing was successful.
The biotechnology firm said the bone-breaking mosquito borne viral fever that caused the major 2006 epidemic possibly entered India from the Indian Ocean islands and that it was the first company to have isolated and characterised the epidemic strain.
Chikungunya, a viral disease that was transmitted to humans by infected mosquitos, was identified in over 60 countries, according to the World Health Organisation (WHO).