H1N1 vaccine: animal trials over,humans next

The animal trials for the much-awaited H1N1 vaccine have been completed by the Pune-based Serum Institute of India (SII). The Institute is hopeful of beginning human clinical trials by December 15....

The animal trials for the much-awaited H1N1 vaccine have been completed by the Pune-based Serum Institute of India (SII). The Institute is hopeful of beginning human clinical trials by December 15.

The firm,which sent a report on the attenuated intranasal spray tests on animals to the Drug Controller General of India (DCGI) on Tuesday,is eyeing a March deadline to bring out the vaccine.

We have successfully completed the animal trials as per our schedule and have send our reports to the DCGI. We are hopeful that they would give us clearances for the human trials by December 15, said Dr Rajeev Dhere,director of the vaccine production unit at SII in Pune.

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The SII conducted the trials on mice and rats for 45 days. It was an extensive study which addressed acute toxicity as well as sub-acute toxicity and the vaccine has cleared it on both fronts. There is nothing abnormal and it is absolutely safe, Dhere said.

SII is proposing multi-centric trials on humans that would include setting up centres in Delhi,Ahmedabad,Chennai and Bangalore apart from Pune. A minimum of 10 sites,to be manned by clinical representatives,have been proposed.

The SII was looking to come out with the vaccine at the earliest in view of the rising number of cases in Pune. It began work on the vaccine in July. SII is also working on the injectible vaccine for H1N1 and the results are expected to come out in the next three weeks.

Two multinational drug makers GlaxoSmithKline Plc(GSK) and Baxter International Inc have got clinical trial approvals while among the Indian vaccine makers,Zydus Cadila has submitted the protocol to the DCGI for approval.