The Hindu Business Line : Bharat Bio to do clinical trials for JE vaccine

Advertisement

Hyderabad Feb. 13 Acambis, the UK-based biotechnology company, has announced the launch of clinical trial of its new, single-dose Japanese Encephalitis (JE) vaccine in children in India in collaboration with Bharat Biotech International (BBI).

ChimeriVax-JE has been developed to be more convenient and safer than the current JE vaccines. Children in endemic areas are at risk from JE, which is a virus transmitted to humans by mosquitoes and is the leading cause of childhood encephalitis and viral encephalitis in Asia.

This is the first time that the vaccine would be tested in children.

An estimated three billion people live in JE-endemic regions, which include Thailand, China, Japan, India and parts of Australia. Every year, there are an estimated 30,000 to 50,000 cases of JE, approximately 25-30 per cent of which are fatal, and a high proportion of survivors are left with serious neurological impairment.

The trial aims to evaluate the safety and immunogenicity of one dose of ChimeriVax-JE compared to two doses of inactivated mouse-brain JE vaccine produced in India. In addition, concurrent vaccination of ChimeriVax-JE and measles vaccine will be investigated in the target age group for immunisation, children aged nine months to two years.

The Acambis' Chief Executive Officer, Mr Gordon Cameron, said: "ChimeriVax-JE has already been tested in approximately 2,400 adult volunteers and we are excited to begin our first paediatric trial in India."

Once approved, the vaccine will be marketed and distributed in India and neighbouring countries by Bharat Biotech. The company will also be responsible for end-stage fill/finish processing of ChimeriVax-JE at its facilities in Hyderabad.

Dr Krishna M. Ella, Chairman and Managing Director of Bharat Biotech, said, "The JE epidemic in 2005, which claimed the lives of more than 1,300 children in Northern India and Nepal, showed the devastating effects of JE and the need for vaccination. Under our partnership with Acambis, we aim to make it easier for children in the Indian subcontinent to be protected against this terrible disease by providing them with a safer, affordable JE vaccine that requires only one dose for immunity."

More Stories on : Announcements | New Products & Services | Pharmaceuticals | Health

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page