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Friday November 2 5:27 PM ET

New Anthrax Vaccine From India Ready for Trials

Slideshows AP Photo Tracking Anthrax

By Subhadra Menon, PhD

NEW DELHI (Reuters Health) - A new, experimental human anthrax vaccine developed in India is ready and waiting for clinical trials, according to Dr. Rakesh Bhatnagar, chairman of the Center for Biotechnology (CBT) at the Jawaharlal Nehru University in New Delhi. The research behind this recombinant technology vaccine will be presented in December at the Annual Meeting of the American Society for Cell Biology in Washington, DC.

This type of vaccine has not been available until now, Bhatnagar told Reuters Health, although it has not yet been tested in humans. Questions have been raised over the safety of current anthrax vaccines, he noted.

``This work is very important for India, not just in the current world scenario, but also because anthrax has always been a common problem in the country,'' said Dr. V. K. Vinayak, advisor at the Department of Biotechnology (DBT), Government of India.

``The vaccine that is developed is not intended for the general public, and is only meant for special groups, such as the forces,'' Vinayak told Reuters Health.

The CBT team genetically engineered Escherichia coli (E. coli) bacteria to produce harmless, mutant forms of the three key proteins (the lethal factor, the edema factor and the protective antigen) found in Bacillus anthracis, the bacterium that causes anthrax.

Bhatnagar and his team are now ready to hand the technology over to industry to produce large quantities of the vaccine for use in human trials. Those trials would determine if the vaccine is safe and effective in humans.

The researchers developed the vaccine with a total grant of roughly $250,000 from India's DBT over the last 7 years. In studies, the investigators found the mutated proteins were good candidates for an anthrax vaccine. The mutation does not affect their molecular shapes, which meant they retained their original ability to generate specific protective antibodies.

``We have so optimized this technology that 30% of the protein that is expressed from the recombined E. coli genome is the protective antigen of anthrax, whereas its expression has been negligible in the past,'' Bhatnagar said.

Having applied for an Indian patent, Bhatnagar is now negotiating the transfer of his vaccine technology with industry and hopes that if there are no glitches, his anthrax vaccine should be in the market in a year or a little over.

``Mass immunisation with a safe and effective anthrax vaccine could thwart attempts of terrorists to use anthrax as a biological warfare agent,'' according to The American Society for Cell Biology.

``In 1994-1995 we decided to initiate a programme on recombinant vaccine development for anthrax and under this the technology developed by Dr. Rakesh Bhatnagar and his team is excellent. There is no other group (in India) working on vaccine development in anthrax,'' Vinayak said.

``Research into infectious diseases has always been a priority area for us in India, and we at DBT have always given special emphasis to the same,'' Vinayak added.

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