Hyderabad: Bharat Biotech said 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.
According to a press release issued by the vaccine maker, the “placebo-controlled” study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen.
The company developed CHIKV vaccine using an isolate of the virus from Indian epidemic and the candidate vaccine was approved by the Drug Controller General of India for phase 1 clinical trials in 2016, it said.
Bharat Biotech Chairman and Managing Director Krishna Ella said chikungunya is one of the most dreaded viruses in modern times, 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,” Ella said.
Bharat Biotech filed a globally pioneering patent in 2007 for CHIKV drawing priority from 2006, and followed up with a second patent in 2011. Patents have been granted in USA, Europe, China, Indonesia and South Africa, the release said.
If phase 1 clinical testing is successful, Bharat Biotech plans to advance the vaccine into phase II and III clinical development.
According to WHO, chikungunya has been identified in over 60 countries. It is a viral disease (genus Alphavirus) which is transmitted to humans by infected mosquitoes.