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Bharat Biotech begins phase-I clinical trials of Chikungunya vaccine
Bharat Biotech on Monday announced that the Phase-I clinical trials of the indigenously developed Chikungunya (CHIKV) vaccine is in progress. The vaccine pioneer in the country is evaluating the vaccine’s safety, tolerability and immunogenicity. The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen, according to a release.
Hyderabad: Bharat Biotech on Monday announced that the Phase-I clinical trials of the indigenously developed Chikungunya (CHIKV) vaccine is in progress. The vaccine pioneer in the country is evaluating the vaccine’s safety, tolerability and immunogenicity. The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen, according to a release.
Bharat Biotech developed the CHIKV 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. 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.
Dr Krishna Ella, CMD of Bharat Biotech, said: “Chikungunya is one among the modern day most dreaded virus. We’re developing an efficient vaccine to prevent it and it’ll save people from risk for infection. Our pre-clinical studies were promising and we hope that the first–in –human clinical trials successfully meet with the clinical endpoints.”
The candidate vaccine under development cross neutralized CHIKV isolates of the Asian genotype isolated in 1963 and isolates from the successive Indian epidemics caused by the East Central South African (ECSA) genotype since 2006. While CHIKV exists as three genotypes, there is only a single serotype of the virus. The candidate vaccine developed by Bharat Biotech effectively cross neutralized both the Asian and ECSA CHIKV genotypes.
“If phase-I clinical testing is successful, Bharat Biotech will advance the vaccine into Phase II/III clinical development. 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,” adds Dr Ella.
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, South Africa and is in National Phase in several other countries.
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 including Aedes aegypti and Aedes albopictus.
By Business Bureau
