Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic

D. K. Hatsukami, D. E. Jorenby, D. Gonzales, N. A. Rigotti, E. D. Glover, C. A. Oncken, D. P. Tashkin, V. I. Reus, R. C. Akhavain, R. E.F. Fahim, P. D. Kessler, M. Niknian, M. W. Kalnik, Stephen Israel Rennard

Research output: Contribution to journalArticle

114 Citations (Scopus)

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-νg 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.

Original languageEnglish (US)
Pages (from-to)392-399
Number of pages8
JournalClinical Pharmacology and Therapeutics
Volume89
Issue number3
DOIs
StatePublished - Mar 1 2011

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Smoking Cessation
Nicotine
Placebos
Antibody Formation
Tobacco Use Disorder
Controlled Clinical Trials
Multicenter Studies
Area Under Curve
Vaccines
Smoking
Odds Ratio
Confidence Intervals
Injections
Antibodies
Serum
Therapeutics

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Hatsukami, D. K., Jorenby, D. E., Gonzales, D., Rigotti, N. A., Glover, E. D., Oncken, C. A., ... Rennard, S. I. (2011). Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clinical Pharmacology and Therapeutics, 89(3), 392-399. https://doi.org/10.1038/clpt.2010.317

Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. / Hatsukami, D. K.; Jorenby, D. E.; Gonzales, D.; Rigotti, N. A.; Glover, E. D.; Oncken, C. A.; Tashkin, D. P.; Reus, V. I.; Akhavain, R. C.; Fahim, R. E.F.; Kessler, P. D.; Niknian, M.; Kalnik, M. W.; Rennard, Stephen Israel.

In: Clinical Pharmacology and Therapeutics, Vol. 89, No. 3, 01.03.2011, p. 392-399.

Research output: Contribution to journalArticle

Hatsukami, DK, Jorenby, DE, Gonzales, D, Rigotti, NA, Glover, ED, Oncken, CA, Tashkin, DP, Reus, VI, Akhavain, RC, Fahim, REF, Kessler, PD, Niknian, M, Kalnik, MW & Rennard, SI 2011, 'Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic', Clinical Pharmacology and Therapeutics, vol. 89, no. 3, pp. 392-399. https://doi.org/10.1038/clpt.2010.317
Hatsukami DK, Jorenby DE, Gonzales D, Rigotti NA, Glover ED, Oncken CA et al. Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clinical Pharmacology and Therapeutics. 2011 Mar 1;89(3):392-399. https://doi.org/10.1038/clpt.2010.317
Hatsukami, D. K. ; Jorenby, D. E. ; Gonzales, D. ; Rigotti, N. A. ; Glover, E. D. ; Oncken, C. A. ; Tashkin, D. P. ; Reus, V. I. ; Akhavain, R. C. ; Fahim, R. E.F. ; Kessler, P. D. ; Niknian, M. ; Kalnik, M. W. ; Rennard, Stephen Israel. / Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. In: Clinical Pharmacology and Therapeutics. 2011 ; Vol. 89, No. 3. pp. 392-399.
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