Nicotine Conjugate Vaccine as a Novel Approach to Smoking Cessation

Anne R. Ottney, Pharm.D

Disclosures

Pharmacotherapy. 2011;31(7):703-713. 

In This Article

Safety

The 3′-AmNic-rEPA vaccine produces antibodies that are highly specific for nicotine, demonstrating excellent discrimination between nicotine and other receptors, ligands, or neurotransmitters in the body. Antibodies from the vaccine remain in the peripheral circulation, limiting central nervous system adverse effects. Data from clinical trials indicate that the most common adverse effects from the 3′-AmNic-rEPA vaccine are mild localized reactions including ache and tenderness. Systemic reactions such as headache, myalgia, and malaise have been reported in vaccinated subjects. Local reactions were found to resolve 1–2 days after vaccination, and systemic reactions resolved on average in 1.5–3 days.[14] Development of type 3 immune-complex hypersensitivity reactions have not been observed in clinical trials. Findings of herpes zoster in a small percentage of patients from a phase II trial will require further study.

An early trial with the nicotine vaccine demonstrated that over 40% of those receiving the active vaccine experienced weight gain compared with 0% in the placebo group.[19] This was a small trial with only 30 subjects, and the authors cautioned that their findings should be considered preliminary. Weight gain has not been reported as a common adverse effect in other trials with the 3′-AmNic-rEPA vaccine. A trial involving another nicotine vaccine showed a nonsignificant difference in weight gain compared with placebo (10.5% vs 11.6%; odds ratio 0.9, 95% CI 0.4–1.8).[23] Weight gain is a common concern for individuals quitting smoking, and data would indicate that the 3′-AmNic-rEPA vaccine does not have a significant impact on this unwanted adverse effect.

Drug Interactions

To our knowledge, no formal drug interaction studies have been performed with the 3′-AmNic-rEPA vaccine. Individuals taking corticosteroids and immunosuppressive agents were excluded from clinical trials as these agents may interfere with the efficacy of the vaccine. Because the vaccine is administered as an intramuscular injection, minimal effects on the hepatic cytochrome P450 system are expected. Caution should be used when administering intramuscular injections to patients receiving anticoagulation therapy or individuals with thrombocytopenia because of the potential for bleeding.

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