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| | | ![]() Nicotine Vaccine Shows Promise in Smokers Wanting to Quit: Presented at AHA By Emma Hitt, PhD ORLANDO, FL -- November 8, 2007 -- Smokers who want to quit may benefit from a nicotine vaccine that can produce high nicotine-specific antibody titers and correlated with smoking abstinence in a phase 2 trial. Stephen I. Rennard, MD, Professor of Medicine, University of Nebraska Medical Center, Omaha, Nebraska, presented the study findings here at the American Heart Association (AHA) 2007 Scientific Sessions. This randomized, double-blind, placebo-controlled, clinical trial included 301 healthy individuals (52% female, 48% male) who smoked >=15 cigarettes per day. Expired CO2 levels (<=8 ppm) were used to confirm self-assessed reports of smoking abstinence during weeks 19 to 26 following vaccination. The study subjects receiving the vaccine were grouped by measured antibody levels into low- and high-titer groups. The highest 30th percentile of titer-producing individuals comprised the high-titer group. The high-titer group had significantly more subjects reporting smoking abstinence in the designated study period than the placebo group (24.6% vs 13%). In addition, the subjects who did not develop high titers were statistically similar in abstinence level compared with the placebo group. "It is unlikely than any treatment will remove any kind of craving. The best to hope for is that the intensity will be reduced -- hopefully a lot," said Dr. Rennard. "It is also hard to separate the physical from the psychological with regard to addicting drugs." "Not everyone will want shots, though some may prefer them. Nonetheless, it is important to have a battery of options to help smokers quit," he added. According to Dr. Rennard, several other nicotine vaccines are in development. These data are presented 6 months postvaccination and this trial will continue for 6 more months. The next step will be a phase 3 trial of this antibody, so this type of vaccine may not be available for at least 2 years.
[Presentation title: A Randomized Placebo-Controlled Trial of a Conjugate Nicotine Vaccine (NicVAX®) in Smokers Who Want to Quit: 12 Month Results. Abstract 3712]
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