Bharat Biotech International Limited (BBIL), a leading hepatitis B vaccine manufacturer in India is in the process of readying the first ever indigenous rotaviral diarrhoea vaccine for clinical evaluation within months from now.

The company has agreed to make available the test lots for Phase I and Phase II (toxicity and safety) studies latest by March 31, 2003. The trials will mark the completion of a decade long R&D activities involving several international and national institutes that took place in several parts of the world.

Rotavirus is a major causative agent of childhood diarrhoea resulting in acute infantile gastroenteritis. Rotaviral diarrhoea is one of the common killer diseases in tropical regions of the world and claims about 150,000 to 200,000 infant lives per year in India alone. At present there is no effective vaccine against the disease in the world.

According to highly placed BBIL sources, the company has been given the responsibility to accomplish the task of producing the vaccine by Program for Appropriate Technology in Health (PATH), an international NGO supporting the cause of children vaccination all over the world. The Children's Vaccination Programme (CVP) of PATH is funded by US based Bill & Melinda Gates Foundation. The foundation has earmarked$6.4 million for the whole programme, it is learnt.

BBIL's role in the programme will be to handover the vaccine for Phase III clinical trials to All India Institute of Medical Sciences (AIIMS), New Delhi, within the prescribed date. AIIMS will undertake the trials in five centers spread across the country. Once the vaccine has undergone successful trials, BBIL would be asked to commercialize the product. The company is known to have chipped in enough energy and resources already into the project and is readying to complete the job well ahead of the deadline. Though it is a 5-year project, BBIL hopes to market the vaccine by 2005.

Interestingly it is for the first time natural Indian strains are being used for the production of rotavirus vaccine in the world. This virus strain was identified during an epidemiology study conducted in Indian Institute of Sciences (IIs), Bangalore. The scientists ascertained that the virus strain I321 was infecting only newborn children, specifically infants aged below three months. Detailed characterization of the virus also revealed that I321 was a naturally evolved reassortant between a bovine rotavirus and a human rotavirus.

Earlier, research on the vaccine was carried out in India as part of Indo-US Vaccine Action Programme for the 14 years. It also had the patronage of the Department of Biotechnology, which helped sustain the research efforts made by the scientists.

The current project using the natural virus strain was initiated by Dr Rogel I Glass, chief of Viral & Gastroenteritis section of Centers for Disease Control and Prevention, Atlanta. The Stanford University, USA and CDC, Atlanta are also actively participating in the programme. They will be evaluating and monitoring the clinical trial protocols and data from time to time.'