Hyderabad-based vaccine manufacturer Bharat Biotech has said the first phase of human clinical trials of Chikungunya vaccine
Hyderabad, Jun 7: Hyderabad-based vaccine manufacturer Bharat Biotech has said the first phase of human clinical trials of Chikungunya vaccine are underway to evaluate it’s safety , tolerance and immunogenicity.
The placebo-controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in the prime-boost regimen, the company said in release here today.
Bharat Biotech had developed the vaccine using an isolate of the virus from Indian epidemic.
The inactivated virus vaccine developed by the in-house R&D was found to be safe and immunogenic in pre-clinical animal testing.
If phase one clinical testing is successful, it plans to advance the vaccine into phases two and three clinical development, Bharat Biotech Chairman and Managing Director Krishna Ella said.
‘Our pre-clinical studies were promising and we hope that the first–in–human clinical trials successfully meets with the clinical endpoints,’ he asserted.
After successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the DCG(I) for Phase 1 clinical trials in 2016.
“Chikungunya is one of modern day’s most dreaded virus, and developing an efficient vaccine to prevent it means a lot to people at risk for the infection,” said Krishna Yella.
The company filed a patent in 2007 for CHIKV drawing priority from 2006 and followed up with a second patent in 2011.
Patents have been granted in the United States, Europe, China, Indonesia, South Africa and several other nations.
The bone-breaking mosquito-borne viral fever that caused a major epidemic in 2006 is believed to have entered the country from the Indian Ocean islands.
Bharat Biotech claims to be the first company to have isolated and characterised the epidemic strain.
In October 2016, the company announced that it completed the pre-clinical studies on one of the two Zika virus vaccine candidates it had developed in-house.