Thursday, August 16, 2007

First Human Trial of Multiple Sclerosis DNA-based Vaccine

Via guardian.co.uk -

The first human trial of a DNA-based vaccine to combat multiple sclerosis has been declared a success by doctors in America after tests on patients revealed signs that their condition had improved. However, the trial is only the first small step in developing an effective treatment against the debilitating degenerative disease, which affects about 85,000 people in the UK.

The vaccine works by dampening down the immune system, which is believed to become overactive in people who develop multiple sclerosis.

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The main purpose of the trial was to test the safety of the vaccine, the first to be tested in humans to treat an autoimmune disease such as MS.

Any side effects were brief and were considered to be mild or moderate, according to a report in the US journal Archives of Neurology.

The doctors went on to test blood from the patients to see how their immune systems had responded to the vaccine. They found that levels of immune cells that specifically attack myelin sheaths had fallen, along with levels of antibodies which are also implicated in the disease.

The doctors recorded eight relapses, though only one occurred in a patient who was receiving the experimental vaccine. After treatment, the patient continued on the trial and experienced no further relapses. All of the other relapses happened five to 29 weeks after the patients received their final dose of vaccine.

The patients were later given magnetic resonance imaging brain scans to examine the damage caused by the disease. As the disease progresses, it produces lesions which can be counted and measured. In the trial, the researchers saw the number of lesions fall by 18% to 64% in patients who were given the DNA vaccine alone. The size of the lesions also dropped, by between 38% and 83%. The statin drug did not seem to improve the vaccine's effectiveness.

The researchers were excited by the results, but cautioned against reading too much into the trial's findings. "We have demonstrated in this first, to our knowledge, in-human trial of a DNA vaccine for autoimmune disease that the approach is safe and well-tolerated. We describe evidence for induction of favourable trends on brain MRI, indicating a reduction in the inflammatory response in the central nervous system," they wrote.

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