The novel combination vaccine for rabies, developed by the Bangalore-based Indian Institute of Science and Indian Immunologicals Ltd, has been cleared by DCGI for conducting animal trials on dogs and cattle.

Although the research was for the development of rabies vaccine for both veterinary and human use, the clearance from DCGI is only for conducting trials for the veterinary version. The DCGI granted permission after being satisfied with the pre-clinical toxicity studies on animals conducted at the National Institute of Nutrition, Hyderabad.

The trial for the world's first combination vaccine containing DNA vaccine which contains a low of dose of cell culture vaccine is being carried out at all the Veterinary Institutions in the country and the final data is expected in the next three months. The combination vaccine will cost much less than the existing ones in the market.

While the conventional rabies vaccine manufacture involves large-scale culture of rabies virus in vertebrate cells, purification and inactivation of virus, which makes it expensive requiring cold storage facilities. Such a proposition is unviable in the rural parts of the country where the rabies is on the rise. But the novel rabies vaccine has managed to emerge as a cheaper option saving on cost and storage as it can be stored at room temperature, Prof. PN Rangarajan, assistant professor, department of biochemistry, Indian Institute of Science told Pharmabiz.com

The novel rabies vaccine contains two components: DNA encoding rabies virus surface glycoprotein (DNA vaccine) and a small quantity of inactivated rabies virus. It will sold under the brand name 'Dinarab' by Indian Immunologicals, informed Prof. Rangarajan.

Since cost of production of DNA is lower than that of virus and the vaccine contains only low amounts inactivated virus, we envisage that this vaccine will be less expensive than the conventional cell culture rabies vaccine. Further, the presence of DNA is likely to increase the stability and shelf life of the vaccine, he stated

The research project for the DNA rabies was an industry-institute initiative, which spanned over a period of two years funded by Indian Immunologicals. There was an additional funding to the tune of Rs. 70 lakh sanctioned by the Department of Biotechnology, government of India under the Prime Minister Jai Vignan Vaccine Mission Programme for the pre-clinical toxicology studies which is expected to be continued until the final trial on animals are completed.

Another noteworthy achievement of the rabies vaccine is that it has received a PCT Patent from South Africa and the European Patent Committee has asked for a few amendments to be made in the patent application filed last year.