Bharat Biotech on Monday said the Phase I human clinical trials of the indigenously developed Chikungunya (CHIKV) vaccine is underway in India to evaluate its safety, tolerability and immunogenicity.

The placebo-controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen, the Hyderabad-based company said in a statement.CHIKV vaccine has been developed using an isolate of the virus from the Indian epidemic. The inactivated virus vaccine was found to be safe and immunogenic in pre-clinical animal testing.After successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the Drug Controller General of India for Phase I clinical trials in 2016. 

"Our pre-clinical studies were promising and we hope that the first-in-human clinical trials successfully meets with the clinical endpoints," said Krishna Ella, Chairman and Managing Director of Bharat Biotech.The bone-breaking mosquito-borne viral fever that caused the major 2006 epidemic possibly entered India from the Indian Ocean islands, and Bharat Biotech was the first company to have isolated and characterised the epidemic strain, the statement said.According to the World Health Organisation, Chikungunya has been identified in over 60 countries. It is a viral disease (genus Alphavirus) which is transmitted to humans by infected mosquitoes including Aedes aegypti and Aedes albopictus.