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Drug Company Seeks Approval for Human Testing of Vaccine against H5N1 Virus

by Medindia Content Team on July 10, 2006 at 5:14 PM
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Drug Company Seeks Approval for Human Testing of Vaccine against H5N1 Virus

British Drug company, PowerMed is seeking approval for conducting the first human trials of experimental vaccine against the deadly strain of avian flu virus H5N1.

The World Health Organisation has reported 97 human cases of avian flu since December 2003, with at least 53 deaths.

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The company has submitted its plans for the trial to the UK Medicines and Healthcare Products Regulatory Agency. The Agency is expected to approve the vaccine for the trial to proceed at a London hospital.

While the government has stockpiled antiviral drugs Tamiflu and Relenza against avian flu the vaccine could help to limit the infection's spread if a pandemic strain emerges. Unlike most other conventional vaccines that use weakened strains or fragments of the harmful virus, this test vaccine uses strands of DNA , making it a faster and more cost effective option.
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During the trial, the volunteers are expected to be vaccinated with a handheld device that will blast harmless, microscopic gold particles coated in the vaccine into the upper arm at supersonic speeds.

Earlier this year tests of a DNA vaccine that was designed to give protection against seasonal flu showed that it offered 100% protection, based on the immune response of volunteers. The DNA vaccine against avian flu has been tested only in animals, so far, where it has proved successful.

According to John Beadle, chief medical officer of the Oxford-based company PowderMed, 'Our tests have shown that it stops the infection entirely, to the point that we can't even measure the virus in the animals afterwards.'

The company's research has suggested that humans would require two doses of the vaccine, a prime and a boost. Half a kilogram of DNA would suffice for two doses of the vaccine for everyone in Britain.

The details of the trial are put up on the government's website, Clinicaltrials.gov where the company has statecd that was seeking 75 volunteers for the trial at Guy's drug research unit in London.

If the trial goes ahead as planned, volunteers will be tested over several months to monitor how long the vaccine remains effective. Preliminary results are expected in January next year.

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