RVDP is a collaborative effort with support and guidance from the Department of Biotechnology, Program for Appropriated Technology in Health (PATH), US Centres for Disease Control and Prevention (CDC), Stanford University, US National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Society for Applied Studies, India's National Institute of Immunology, Indo-US Vaccine Action Program, All India Institute of Medical Sciences and the Hyderabad-based Bharat Biotech International Ltd (BBIL).
According to BBIL, the 116E vaccine candidate has undergone extensive characterisation and quality control testing at its facilities and also at external agencies abroad. The phase III clinical trials for the vaccine are planned to start in 2009.
Rotavirus infections are stated to be the single largest cause of severe diarrheal disease among infants and children worldwide and cause more than 500,000 deaths each year, with 90 per cent of these deaths occurring in the world's poorest countries. Rotavirus diarrhea causes more than 120,000 deaths in India alone.
The phase I/II trial was conducted on healthy non-malnourished infants 8-20 weeks of age with safety and immunogenicity as the primary and secondary objectives. The study was conducted by the Society for Applied Studies in New Delhi. A total of 369 infants were enrolled for the study. The early clinical results were encouraging and warrant further development of ORV 116E as a new rotavirus vaccine for young infants in developing world settings, BBIL said.
