Department of Biotechnology (DBT) has started scouting for industrial partner to licence and commercialise a live, oral cholera vaccine (IOCV) strain, with a view to make an affordable vaccine available in domestic and overseas markets.
The recombinant oral vaccine is based on VA1.3 strain on V cholerae and has been developed through a multi-centric approach. The vaccine was tested for its safety in phase – I clinical trials and was found to be safe. The extended phase-I/phase-IIa clinical trial recently completed by SAS, Kolkata and SGPGIMS, Lucknow has shown good immunological response, sources said.
So far, about 100 volunteers in the age of 20-30 years have been inducted in the phase-IIa trials. Data from volunteers showed eight-fold rise in 42 per cent of the cases; two-fold rise in 33 per cent and no rise in 25 per cent. In addition, preparation around Kolkata for phase-III clinical trial has been initiated in terms of determining the base-line antibody levels in local population. Concurrently, IMTECH, Chandigarh is making attempts to scale up of VA1.3 strain of Vibrio cholerae in LB medium. After several attempts using a semi-synthetic medium, a healthy growth of V.cholerae VA1.3, has been obtained. The cells were found to be both physiologically and genetically stable.
DBT supported the development of a live cholera vaccine using recombinant technology that is administered orally. The vaccine is safe, non-residual and significantly immunogenic.
The vaccine strain has been patented in USA and India and all necessary regulatory approvals required for recombinant products as per EPA, 1986 obtained. It is now being produced in a GMP facility for a large scale phase-III trial, sources said.
The intent of DBT is guided by the fact that the Strategic Advisory Group of Experts (SAGE) of WHO in October 2009 has advocated cholera control as a priority in areas with endemic cholera since outbreaks can disrupt health systems. Vaccination in such areas should be targeted at high-risk areas and population groups. Recombinant IOCV is a one-dose vaccine, ensuring lower drop-out rate from the vaccination schedule, DBT said while inviting expression of interest from pharma firms.