The University of Nebraska Medical Center is one of about 20 centers around the country that will involve 1,000 people in the last test phase of NicVax, a nicotine vaccine made by Nabi Biopharmaceuticals. If the study is successful, the company will seek approval from the Food and Drug Administration to market the vaccine.
The UNMC study will involve 40 to 50 men and women at least 19 years old. It will require study participants to make a number of visits to UNMC over about a year.
In previous studies, the vaccine, given by injection in various intervals, has been found to be twice as effective when compared to the placebo quit rate of 5 to 15 percent.
NicVax is one of several nicotine vaccines being tested.
“The vaccine may be another useful tool in smoking cessation,” said Stephen Rennard, M.D., Larson Professor of Medicine, UNMC Pulmonary and Critical Care Section, and principal investigator of the UNMC study.
“The availability of a different strategy is very important,” he said. “It’s a different way to treat nicotine addiction, which has a powerful hold on the brain.”
He said the vaccine works in part by reducing the pleasurable effects of smoking and reduces or eliminates many of the withdrawal symptoms, such as irritability, insomnia, difficulty concentrating, weight gain and depression.
UNMC has been involved in previous phases of the NicVax study. This study phase will make refinements in the dosage and timing of the administration of the vaccine. It also has been involved in national studies that have helped commercialize smoking cessation products such as the nicotine patch, nicotine gum, Zyban and Chantix.
The study is funded in part by the U.S. National Institutes of Health.
Dr. Rennard has in the past served as an advisor for Nabi Biopharmaceuticals.
For more information about the study, contact Mary Carlson at (402) 559-6726 or mlcarlso@unmc.edu, or Deb Sumnick, (402) 559-3025 or dsumnick@unmc.edu.