Bharat Biotech’s chikungunya vaccine enters phase 1 clinical trials

05-06-2017
HT

Hyderabad-based Bharat Biotech that is known for producing affordable and effective vaccines, including that for influenza A H1N1, swine flu, in the recent past, announced today it has entered human clinical trials for its chikungunya vaccine.

Chikungunya is a mosquito-borne viral infection that causes excruciating bone and joint pain.

The indigenously developed chikungunya vaccine—CHIKV— has entered the Phase 1, first in human clinical trials of vaccine, to evaluate the vaccine’s safety, tolerability and immunogenicity.

There are four phases in all and it could take years before the vaccine finally is ready for use.

The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen.

The vaccine has been developed using an isolate of the virus from Indian epidemic.

The inactivated virus vaccine developed by the in-house research and development (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 Drug Controller General of India for Phase 1 clinical trials in 2016.

“Chikungunya is one among the modern day most dreaded virus, and developing an efficient vaccine to prevent it means a lot to people at risk for the infection. 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, Bharat Biotech.

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.

The company 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.

If phase 1 clinical testing is successful, Bharat Biotech plans to 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.

According to World Health Organisation, the disease has been identified in over 60 countries. It is a viral disease that is transmitted to humans by infected mosquitoes, including Aedes aegypti and Aedes albopictus.

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