Roswell Park Cancer Institute researchers have begun a clinical trial to examine if a new vaccine can help the body control nicotine cravings.
Roswell Park is among 20 sites nationwide participating in the clinical trials for the NicVAX vaccine. The trial is led by Dr. Martin Mahoney, an associate professor in the departments of health behavior and medicine.
The phase III clinical trial will enroll 50 smokers, between the ages of 18 and 64. Half of the participants will receive four doses of the drug, four weeks apart, while continuing to smoke. The control group will be given a placebo. For all participants, a quit-smoking date will be set for two weeks after the fourth injection, after which the test group will receive two additional "booster doses" to help keep them from starting up again.
In a prepared release, Mahoney explained the vaccine works by interfering with the transmission of neurotransmitters that produce pleasure in the brain and drives various addictions, including nicotine dependence. NicVAX is designed to produce antibodies that serve as a sponge, soaking up the nicotine so there's less of it circulating in the bloodstream.
Other nicotine-based smoking cessation products currently available in the form of gum, lozenges, patches, nasal sprays and inhalers are designed to work in a different way, delivering nicotine in steady doses or at intervals, then gradually reducing the amount over time to wean smokers.
Other institutions selected to participate in the trial include M.D. Anderson and the Mayo Clinic. The phase III clinical trials are the last step on the road to FDA approval.