Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic

Clin Pharmacol Ther. 2011 Mar;89(3):392-9. doi: 10.1038/clpt.2010.317. Epub 2011 Jan 26.

Abstract

NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response. This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-µg doses administered four or five times over a period of 6 months, as compared with placebo. 3'AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26. The five-injection, 400-µg dose regimen elicited the greatest Ab response and resulted in significantly higher abstinence rates than placebo. This study demonstrates, as proof of concept, that 3'AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.

Trial registration: ClinicalTrials.gov NCT00318383 NCT00598325.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies / immunology
  • Area Under Curve
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nicotine / immunology*
  • Smoking Cessation / methods*
  • Tobacco Use Disorder / immunology
  • Tobacco Use Disorder / rehabilitation*
  • Treatment Outcome
  • Vaccines / administration & dosage
  • Vaccines / immunology
  • Vaccines / therapeutic use*
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / immunology
  • Vaccines, Conjugate / therapeutic use*

Substances

  • Antibodies
  • NicVAX
  • Vaccines
  • Vaccines, Conjugate
  • Nicotine

Associated data

  • ClinicalTrials.gov/NCT00318383
  • ClinicalTrials.gov/NCT00598325