Phase I Clinical Trials of CHIKV Vaccine Underway In India : Bharat BiotechJune 06, 2017 11:02
Phase I Clinical Trials of CHIKV Vaccine Underway In India : Bharat Biotech:- Indian vaccines manufacturer, Bharat Biotech announced yesterday that the phase 1 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 would involve around 60 healthy volunteers. The study would test the increasing doses of the vaccine in prime-boost regimen.
The company said in a statement that, using an isolate of the virus from Indian epidemic and the candidate vaccine, the CHIKV vaccine has been developed. Furthermore, it was approved by the Drug Controller General of India (DCGI) for phase 1 clinical trials in the previous year.
Bharat Biotech Chairman and Managing Director Krishna Ella said, in modern times, one of the most dreaded viruses is the Chikungunya virus. And developing an efficient vaccine to prevent it means a lot, for people at risk of the infection.
“Our pre-clinical studies were promising and we hope that the first in-human clinical trials successfully meet with the clinical end points,” said Ella.
A globally pioneering patent was filed in 2007 for CHIKV drawing priority from 2006. The second patent for the CHIKV was drawn in 2011. The release said, in USA, Europe, China, Indonesia and South Africa, the patents have been granted.
If the clinical testing of the phase 1 is successful, the company plans to advance the vaccine into phase II and phase III clinical development.
In over 60 countries, Chikungunya has been identified. It is a viral disease (genus Alphavirus) which is transmitted to humans by infected mosquitoes, says World Health Organization (WHO).