The Hindu Business Line : Bharat Bio says clinical trials on rotavirus vaccines encouraging

BHARAT Biotech International Ltd (BBIL), the Hyderabad-based vaccines and biotherapeutics manufacturer, has announced that the Indian Rotavirus Vaccine Development Project (RVDP) has achieved encouraging results from the recent phase-I clinical trials on two candidate rotavirus vaccines conducted in New Delhi.

The RVDP consists of BBIL, the Union Department of Biotechnology, the Society for Advanced Studies, the US-based Centre for Disease Control, the National Institutes of Health, the Indian Institute of Science, Bangalore, and Stanford University.

The two candidate vaccines represent the products of two independent research teams from RVDP, which 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 was 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 Government of India.

In a press release here on Monday, BBIL said in the randomised, double blind trial, 90 healthy infants aged 8-12 weeks were assigned into three groups (30 per group) to receive a single oral dose of either one of the two candidate rotavirus vaccines, strains 116E or I321, or placebo, developed by it.

Following the encouraging results of the phase-I trial using pilot lots of the candidate rotavirus vaccines manufactured at the US-based National Institutes of Health, the RVDP is now planning clinical trials with cGMP vaccine lots produced by Bharat Biotech, using the same strains, 116E and I321.

These trials would begin in second quarter of this year, the release said.

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