Researchers have found nicotine vaccine (NicVAX®) can help people quit smoking and produce antibodies against nicotine. The possibility of the novel treatment offers tremendous potential for people who haven’t been able to quit.
Cigarette smoking triples the risk of dying from heart disease among middle-aged men and women.
The 12-month study tested the safety, effectiveness and dosing in 301 study participants in nine centers around the country who were at least 19 years old and smoked at least 15 cigarettes a day. The randomized, double-blinded, placebo-controlled phase II clinical trial tested two dose levels of NicVAX,® — 200µg and 400µg and timing of the vaccinations.
NicVAX® is made by Nabi Biopharmaceuticals. The study, which was funded by Nabi Biopharmaceuticals and by the U.S. National Institutes of Health, also determined an appropriate vaccine dosage.
For those receiving the highest antibody dosage (400µg), 24.6 percent achieved an 8-week period of continuous abstinence from smoking between the 19th and 26th week study period, compared to 13 percent for those who received placebo.
Stephen Rennard, M.D., Larson Professor of Medicine, University of Nebraska Medical Center UNMC Pulmonary and Critical Care Section, who presented study results at the conference, said there was a significant relationship between anti-nicotine antibody levels and continuous abstinence from smoking. NicVAX was well-tolerated and showed no differences in adverse events or in local/systemic reactions between placebo and each active vaccine group.
NicVAX® works by preventing nicotine from entering the brain, which in turn may reduce the pleasurable effects of smoking.
Like vaccines that prevent disease, the nicotine vaccine generates antibodies in the body that attach to nicotine molecules, making them larger and more difficult to get into the brain. It is thought that this will allow the vaccine to block the pleasurable effects of smoking.
He said there’s a lot of interest in nicotine vaccines to quit smoking.
“The vaccine is really very different than all of the other drugs. Theoretically, all the other drugs are designed to work in the person’s brain to affect the nicotine addiction process. They can do that and they can help. The vaccine targets the addicting drug and it seems more appealing to attack the enemy.”
Jill Rolf smoked for 50 years. She tried quitting eight to 10 times either by going cold turkey or by using the nicotine patch. But neither worked.
In 2006, she enrolled in the NicVAX study. She hasn’t smoked since Sept. 24, 2006.
Though Rolf had quit smoking before, she said it wasn’t hard to quit this time. She has not had an overwhelming desire to take up smoking again. She remembers only twice where she thought about it — driving through a big cities on a vacation.
"I figured it was about time to quit for my health," Rolf said. She’s also glad she quit because her husband, who smoked for 40 years then quit, was diagnosed June 2007 with emphysema. He now has to use oxygen.
It is not known yet whether Rolf received the nicotine vaccine or not because the study has not been "unblinded" yet – revealing who received the NicVAX.
UNMC is the only public health science center in the state. Its educational programs are responsible for training more health professionals practicing in Nebraska than any other institution. Through their commitment to education, research, patient care and outreach, UNMC and its hospital partner, The Nebraska Medical Center, have established themselves as one of the country’s leading centers in cancer, transplantation biology, bioterrorism preparedness, neurodegenerative diseases, cardiovascular diseases, genetics, biomedical technology and ophthalmology. UNMC’s research funding from external sources now exceeds $80 million annually and has resulted in the creation of more than 2,400 highly skilled jobs in the state. UNMC’s physician practice group, UNMC Physicians, includes more than 460 physicians in 50 specialties and subspecialties who practice primarily in The Nebraska Medical Center. For more information, go to UNMC’s Web site at www.unmc.edu.