The disease burden study and site preparations are progressing to commence the phase-III clinical trials of the first rotaviral diarrhoea vaccine (116E) in the country, being manufactured by Hyderabad-based Bharat Biotech International in collaboration with a host of agencies including the Department of Biotechnology (DBT).

The investigators are doing the disease burden study and the site preparations are going on at three places -- the Society of Applied Studies (SAS), New Delhi, CMC, Vellore and KEM Hospital, Pune. The Phase-III trials would start soon. Around 7000 children are likely to be enrolled for the study. But the launch of the vaccine may still take a couple of years more to make sure the maximum safety and efficacy. The subjects will be monitored regularly for two years before concluding the trials, sources at the DBT said.

Phase-II human clinical trials have been successfully completed. The vaccine induced immune response was reported in 90 per cent of the recipients. The SAS has conducted a clinical trial with financial support from DBT, NIH, and Programme for Appropriate Technology in Health (PATH) to evaluate the safety and immunogenicity of a live attenuated rotavirus vaccine (116E).

Rotavirus induced diarrhoea causes more than five lakh deaths worldwide every year and almost another 20 lakh more fall seriously ill. This is a phenomenon that is prevalent in developing countries like India and the sub-Saharan African region, according to the available data.

The Indian Rotavirus Vaccine Development Project (RVDP) is run by a host of institutions like DBT, SAS, PATH, Centers for Disease Control, Atlanta, Georgia, National Institutes of Health, the Indian Institute of Science, Bangalore, India, and Stanford University, Palo Alto California.