After successfully developing rotavirus vaccine indigenously for the first time in the country, the Department of Biotechnology (DBT) is aggressively pushing itself to replicate the success in the case of dengue and malaria vaccines also.
While malaria vaccine is going through phase I clinical trials, the efforts to develop a vaccine for dengue is into the advanced stages of pre-clinical studies. “We are having a review meeting on June 28 to assess the progress and we will be able to give more details after the meeting,” a senior official of the Department said.
In a major fillip to the Indian attempts to develop affordable vaccines, DBT in collaboration with Bharat Biotech last month announced the successful completion of the phase III trials of a rotavirus vaccine – Rotavac. The vaccine against critical rotavirus, one of the major causes of deaths among the children in the country, will soon be available in the domestic and overseas markets at below one dollar per shot.
The International Centre for Genetic Engineering & Biotechnology (ICGEB), Delhi is leading the programme for developing the malaria recombinant vaccine. ICGEB has focused on developing recombinant sub-unit blood stage vaccine molecules (Plasmodium falciparum and P.vivax).
“The recombinant proteins recognized more than 90 per cent of the malaria endemic sera. Immunogenecity studies in mice and rabbits producing high antibody titres indicate high immunogenic nature of recombinant protein. A GLP facility has been set up. The production of these molecules under GMP facility at Bharat Biotech, Hyderabad is underway. Hyper endemic and low endemic areas of Sundergarh district of Orissa have been selected as the field sites for trials. The high incidence study areas constitute a set of 8 villages in the forest area where Anopheles fluviatilis is the major vector. The low incidence study area consists of five villages in the plain area and A. culifacies has been found to be major vector,” sources said.
Another promising project is development of a sub-unit-based vaccine for dengue, which till now has no vaccine or antiviral drug. Most importantly, all the four serotypes of dengue viruses (DENV-1, -2, -3 and -4) that cause dengue are being taken care of in the project. In consultation with the Indo-US Vaccine Action Programme, the scientists have created DENV-2 EDIII HBsAg virus-like particles (VLPs) and are evaluating these physically and functionally.