Hyderabad, Feb. 13: Acambis plc, a UK-based biotechnology company, said on Tuesday that it has commenced a paediatric clinical trial in India of ChimeriVax-JE, its investigational single-dose vaccine against Japanese Encephalitis (JE).

JE 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 ChimeriVax-JE will have been tested in children, who are at the greatest risk from JE in endemic regions.

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, an Acambis release said.

"The paediatric trial of ChimeriVax-JE is a multi-centre randomised, double-blind, controlled study and will be conducted in healthy children and infannts. 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," the release said.

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.

Once approved, ChimeriVax-JE will be marketed and distributed in India and neighbouring countries by Acambis' partner, the Hyderabad-based Bharat Biotech International Ltd. Bharat Biotech will also be responsible for end-stage fill/finish processing of ChimeriVax-JE at its facilities in India.

Dr Krishna M. Ella, CMD of Bharat Biotech International Ltd., 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."