Twenty-two institutions across the country are participating in a Phase III clinical trial to determine whether a new investigational "nicotine vaccine" is safe, effective and capable of stimulating an immune response. Approximately 1,000 male and female smokers aged 18 to 65 will take part in the 12-month study NicVAX, a vaccine developed by Nabi Biopharmaceuticals.
Nicotine molecules are so small that they can pass through the body's brain/blood barrier without triggering a reaction from the immune system. However, NicVAX stimulates the immune system to produce antibodies that bind to or capture nicotine
molecules in the bloodstream, making them too large to cross the blood-brain barrier. As a result, many of the expected rewards from smoking are blocked, making it easier for the smoker to become and remain abstinent.
“Smokers continue to smoke even when they know it’s harmful because of these ‘brain effects,’” explained David Gonzales, Ph.D., principal investigator and clinical investigator in medicine at the Oregon Health and Science University, one of the 22 test centers. “While a smoking cessation medication such as varenicline prevents nicotine from binding to receptors once it is in the brain, NicVAX is designed to block nicotine before it enters the brain.”
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