The University of Wisconsin Center for Tobacco Research and Intervention will continue its research through a new clinical trial of a vaccine to help people successfully quit smoking.
The vaccine, NicVAX, prevents the pleasure sensation a person receives from smoking, helping to break addiction, said Doug Jorenby, a professor of medicine and director of clinical services for UW-CTRI.
He said unlike patches or gums that introduce the body to chemicals, NicVAX “teaches” your immune system to quit.
“The vaccine allows you to use your immune system to get off cigarettes, rather than something outside the body,” Jorenby said.
Usually, when a person inhales smoke from a cigarette, the nicotine enters the bloodstream unnoticed by the immune system, passes through a blood-brain barrier—a filter which keeps large proteins out of the brain—and attaches to receptors in the brain and triggers the release of dopamine.
Dopamine gives pleasure reinforcement and the person becomes addicted, said Greg Fries, manager of investor relations at Nabi Biopharmaceuticals, the maker of NicVAX. The vaccine works by stopping nicotine from getting through the blood-brain barrier. NicVAX connects nicotine to a larger protein the immune system can recognize and antibodies are made.
The next time a person smokes, antibodies latch on to the nicotine, making it too large to pass through the blood-brain barrier and reach receptors in the brain so the smoker doesn’t receive positive reinforcement, Fries said.
“While [other treatments] may help you quit or reduce the amount of tobacco, it doesn’t get rid of addiction,” Fries said. “With NicVAX, it helps people quit smoking and stay quit for longer. This is the advantage.”
Over the course of six months, UW-CTRI, a research center devoted to helping people quit smoking, will administer the shot to about 60 individuals as part of a 1,000 participant nationwide trial.
Progress will then be monitored for an additional six months to determine the vaccine’s effectiveness in helping people quit for up to a year, Jorenby said.
He added UW-CTRI will begin giving individuals shots in two weeks as the third and last phase of the study before the FDA approves or denies the drug’s release to the public.
To aid the development of NicVAX, Nabi Biopharmaceuticals was granted a fast track status from the FDA.
“The FDA is excited about this line of work as a way to help people quit smoking because smoking is such a problem in the U.S.,” Jorenby said.
Prior to this phase, UW-CTRI also participated in a NicVAX study experimenting with the schedule of injections and amount of doses.
Of 300 people given the shot, the study found 16 percent were still non-smokers at the end of a year compared to the 6 percent who received a placebo, Jorenby said.
While NicVAX can help with the physical addiction when quitting smoking, people need to have their own drive, Fries said.
“Someone has to be willing and wanting to quit smoking; NicVAX helps with physical addiction, but people also need to modify old habits and behaviors,” he said.
