Department of Biotechnology (DBT) has launched a new initiative called 'vaccine grand challenge programme' to accelerate the development of candidate vaccines for which leads are available and to take them through clinical studies and commercialization.
The new programme has been approved after a number of candidate vaccines for rotavirus, cholera, typhoid, rabies, anthrax, malaria, dengue, TB and Japanese encephalitis have been developed under the ongoing National Jai Vigyan Mission. According DBT sources, proposals have been invited from scientists and research bodies to facilitate accelerated development and validation of specific new or improved version of existing vaccines.
Under the 'new generation vaccines programme' of the Jai Vigyan Mission, two candidates vaccines (116E and 1321) have been developed for rotaviral diarrohea. The first one has completed phase-11 trials. The phase-111 trial will begin by the end of this year, as sites have been already prepared, sources said.
An oral, live, recombinant, non-residual cholera candidate vaccine has been developed using novel methods of strain isolation and genetic manipulations. And it was clinically tested and the candidate is being manufactured for large scale trials. "The formulation for the vaccine has been worked out and batch data on stability is being collected for regulatory purposes. The site preparation is also going on parallel," sources said.
The efforts at ICGEB, New Delhi, in collaboration with National Institutes of Health, USA, resulted into two candidate vaccines for malaria. The recombinant candidate antigens have been produced under GLP conditions at a pilot scale. Bharat Biotech International, Hyderabad, has already provided three batches of vaccine to initiate pre-clinical and clinical trials. A filed trial site has been prepared at Malaria Research Centre, Rourkela for trials, sources said.
"While the work on tissue culture based vaccine for Japanese encephalitis, which was transferred to Panacea Biotech, has progressed towards establishing tools and techniques for phase-1 trials, a new approach using Aadeno-based vectors as a backbone for JE DNA vaccine has shown encouraging results. The department is in touch with many companies for partnership for further development," an official said.