Promising Vaccine for Smokers
By Darrell Hulisz, RPh, PharmD
Tobacco smoking accounts for approximately 400,000 premature deaths annually in the United States and is often cited as the number one cause of preventable premature death (Escobar-Chavez, 2011). Novel approaches to assist patients with nicotine dependence are being studied, in particular, a vaccine aimed at evoking an immunologic response against nicotine. Several pharmaceutical companies are developing vaccines and conducting clinical trials for use in smoking cessation.
The vaccine’s mechanism is based on stimulating production of nicotine antibodies to sequester circulating nicotine, preventing its passage into the brain which normally perpetuates the reward and addiction cycle. The vaccine is made by linking nicotine or a similar molecule, to a known immunogenic protein, thus causing the immune system to see the combined agent as foreign. The body reacts by stimulating the production of specific antibodies against nicotine.
Cytos developed a nicotine vaccine known as NIB002. The company partnered with Novartis AG and was granted an IND (Investigational New Drug) for a Phase II clinical trial. Nabi, Inc. developed a vaccine known as NicVAX. However, two Phase III trials failed to meet their primary study efficacy endpoints. In these early trials, the vaccine produced nearly 100% nicotine antibody response and adverse reactions were reportedly mild (Hatsukami, 2011). Some patients have had flu-like symptoms or injection-site reactions.
Unfortunately, sustained smoking cessation rates over 3-6 months were similar to outcomes with a placebo. But, despite various setbacks and neutral results, other companies, such as Celtic Pharma, continue to move forward in developing an effective nicotine vaccine. Researchers predict it may be more than a year before any new preliminary clinical trial data becomes available (Leader, 2010).
Escobar-Chavez JJ, Dominguez-Delgado CL, Rodriguez-Cruz IM. Targeting nicotine addiction: the possibility of a therapeutic vaccine. Drug Design, Development and Therapy 2011:5 211-224.
Hatsukami DK, Jorenby DE, Gonzales D, et al. Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clin Pharmacol Ther 2011 Mar;89(3):392-9.
Leader AE, Lerman C, Cappella JN. Nicotine vaccines: will smokers take a shot at quitting? Nicotine Tob Res 2010 Apr;12(4):390-7.
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Darrell Hulisz, RPh, PharmD currently practices as a clinical pharmacist with University Hospitals of Cleveland, Family Medicine Residency Program, where he works in consultation with family physicians, both on inpatient and outpatient services.