A number of projects aided by the Department of Biotechnology to develop vaccines for diseases like malaria, dengue and TB at the public sector institutions and in collaboration with the private partners are well on track. Though these projects have made significant progress so far, it will take some more years to come out with tangible results to benefit the people, according to the department sources.

A project on malaria vaccine development is continuing at ICGEB New Delhi, NIMR New Delhi, Ispat General Hospital, Rourkela. The cell bank and technology for production of recombinant PfMSP-1 and PfF2 have been transferred to Bharat Biotech International Ltd (BBIL), Hyderabad for developing master cell bank and master working cell bank and for characterisation.

The BBIL has produced cGMP grade material in three batches for clinical trial and toxicological studies. Trial site has been developed at Sundergh district of Orissa through collection of clinical, entomological and molecular epidemiological indicators for the study. The group conducted longitudinal entomological surveys in two indicator villages. The results suggested that there was a boosting in antibody production against these molecules by natural infections in these individuals, sources said.

Culminating efforts from 1996, an oral live recombinant cholera vaccine (VA1.3) has been developed. Phase-I trials were conducted at the Society of Applied Studies (SAS) Kolkata and SGPGIMS, Lucknow. Out of 24 volunteers, none shed the vaccine strain. A parallel phase-II study at the same two places undertook the extended clinical trial. About 300 volunteers were involved in the tests and data revealed eight-fold rise of vibriocidal titre occurred in 42 per cent volunteers and a two-fold in 33 per cent.

"A strain VA1.4 vaccine is slated for testing on a larger population to check the efficacy in protecting cholera infection. It is being aimed to prepare the clinical grade vaccine at cGMP conditions with a competent industrial partner and conduct trials jointly at NICED, Kolkata, SAS, Kolkata. The trial would estimate efficacy of a single-dose primary regimen in at least one year of age of eastern Kolkata, in preventing culture-proven V cholerae 01 diarrhoea episodes," an official said.

As part of developing a vaccine for dengue, a novel tetravalent chimeric protein by fusing the receptor-binding envelope domain III (EDIII) of the four dengue virus serotypes has been developed at ICGEB. This protein has been expressed in the yeast. It is being transferred to an industrial partner.

In the research to develop a vaccine for Japanese encephalitis, a project on the development of a tissue culture-based vaccine was carried out at NII, New Delhi. The vero cell-derived, inactivated JEV vaccine was successfully transferred to Panacea Biotech. In the case of typhoid, the Vi-conjugate typhoid vaccine development effort is being continued by USV Ltd, Mumbai under SBIRI programme. Currently, emphasis is being given on preparation of GMP grade immunogens, preclinical toxicology and phase 1 human clinical trial with the regulatory approvals.