Bharat Biotech & Partners develop an indegenous rotavirus vaccine

17-Feb-2006

The Indian Rotavirus Vaccine Development Project (RVDP) announced encouraging results from a recent Phase I clinical trial of two live, natural reassortant, candidate rotavirus vaccines, 116E and I321, conducted in New Delhi, India. The RVDP consisting of the Department of Biotechnology (Govt. of India), Bharat Biotech International Limited, Hyderabad India, Society for Advanced Studies, New Delhi India, Centers for Disease Control, Atlanta GA, National Institutes of Health, the Indian Institute of Science Bangalore, India and Stanford University, Palo Alto CA have worked together for the past several years. Rotavirus is the leading cause of severe diarrhea in children worldwide and accounts for approximately 400,000 hospitalizations and 160,000 deaths in India alone.

The two candidate vaccines represent the products of two independent research teams from RVDP who have worked in parallel for more than a decade under the auspices of the Indo-US Vaccine Action Program (VAP) and have combined their efforts through the RVDP. The phase-I clinical trial in India has been carried out by Society for Applied Studies, New Delhi. The RVDP receives financial support primarily from the Gates Foundation, through the Program for Appropriate Technology in Health (PATH), Seattle, with additional support from the Indo-US VAP, the Department of Biotechnology, and Govt. of India.

Following the encouraging results of this phase I trial using pilot lots of the candidate rotavirus vaccines manufactured at the National Institutes of Health, USA, the RVDP is planning clinical trials with cGMP vaccine lots produced by Bharat Biotech, using the same strains, 116E and I321. Bharat Biotech International Limited Hyderabad is a leading manufacturer of vaccines and biotherapeutics in India. Bharat Biotech has successfully developed the 116E and I321 human rotavirus strains as vaccine candidates. The 116E and I321 vaccine candidates have undergone extensive characterization and quality control testing at Bharat Biotech and at external agencies with the global standards. These trials are planned to begin in Q2 of 2006.

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