Acambis starts trial of JE drug

Acambis Plc, a UK-based leading biotechnology company targeting infectious diseases, has commenced a paediatric clinical trial in India of ChimeriVax-JE, its investigational single-dose vaccine against Japanese encephalitis (JE), in collaboration with Hyderabad-based Bharat Biotech International Limited (BBIL).

The paediatric trial of the vaccine is a multi-centre randomised, double-blind, controlled study and will be conducted in healthy children and infants. The trial aims to evaluate the safety and immunogenicity of one dose of ChimeriVax-JE compared with 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.

JE is a virus transmitted to humans by mosquitoes and is stated to be 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.

"ChimeriVax-JE has already been tested in approximately 2,400 adult volunteers and we are excited to begin our first paediatric trial in India, a country with JE-endemic regions in great need of a safe, single-dose, affordable vaccine to prevent this dreadful disease," Acambis' chief executive officer Gordon Cameron said.

Once approved, ChimeriVax-JE will be marketed and distributed in India and neighbouring countries by Acambis' partner, Bharat Biotech International Limited (Bharat Biotech). One of India's leading biotechnology companies, Bharat Biotech will also be responsible for end-stage fill/finish processing of ChimeriVax-JE at its facilities in India.

"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," chairman and managing director of BBIL Krishna M Ella said.