The long wait for an effectual vaccine to combat deadly H1N1 flu in India could be over in the coming months if the intra-nasal spray produced by Serum Institute of India (SII) gets tested in a successful manner on human being next week.

After getting nod from Drug Controller General of India (DCGI), SII, which has already forwarded a report on toxicity and tolerance of the vaccine in animal experiments, is now in the process of discovering 50 "completely healthy" adults to carry out 'phase- I' human clinical experimentations in Delhi, Pune and Ahmedabad.

The statement was made by Dr. Rajiv Dhere, director, Serum Institute of India (SII).

Dr. Prasad Kulkarni, in charge of the Human clinical tests of the vaccine said, "Phase one of the human clinical trials of the vaccine will be conducted by a designated CRO [Clinical Research Organisation] in Ahmedabad. We cannot disclose the name of the CRO. The trials will be conducted on 50 healthy adult volunteers. Phase one will check for the safety of the vaccine."

Dr. Kulkarni also said that SSI anticipated the early facts of the human experiments to be available by the coming month (Feb 2009).

"Once we have confidence in the safety of the vaccine, phase two would start. It would be conducted in multiple centres unlike phase one that is to be conducted in Ahmedabad alone. The data of phase two should be available by March-end or early April," he added.

After that, the vaccine would go for commercial production.

In India, the vaccine for swine influenza is being made by Panacea Biotech Limited (New Delhi) and Bharat Pharmaceuticals (Mumbai) and the SSI in Pune.

The SSI was part of a global teleconferencing held by WHO Director-General Margaret Chan in order to discuss developing a preventive H1N1 vaccine hours after the malady was announced a worldwide epidemic.