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Reference: Cornuz, J, Zwahlen, S, Jungi, WF et al., (2008). A vaccine against nicotine for smoking cessation: a randomized controlled trial. PloS one, 3 (6), e2547.Citable link to this page:


A vaccine against nicotine for smoking cessation: a randomized controlled trial.

Abstract: BACKGROUND: Tobacco dependence is the leading cause of preventable death and disabilities worldwide and nicotine is the main substance responsible for the addiction to tobacco. A vaccine against nicotine was tested in a 6-month randomized, double blind phase II smoking cessation study in 341 smokers with a subsequent 6-month follow-up period. METHODOLOGY/PRINCIPAL FINDINGS: 229 subjects were randomized to receive five intramuscular injections of the nicotine vaccine and 112 to receive placebo at monthly intervals. All subjects received individual behavioral smoking cessation counseling. The vaccine was safe, generally well tolerated and highly immunogenic, inducing a 100% antibody responder rate after the first injection. Point prevalence of abstinence at month 2 showed a statistically significant difference between subjects treated with Nicotine-Qbeta (47.2%) and placebo (35.1%) (P = 0.036), but continuous abstinence between months 2 and 6 was not significantly different. However, in subgroup analysis of the per-protocol population, the third of subjects with highest antibody levels showed higher continuous abstinence from month 2 until month 6 (56.6%) than placebo treated participants (31.3%) (OR 2.9; P = 0.004) while medium and low antibody levels did not increase abstinence rates. After 12 month, the difference in continuous abstinence rate between subjects on placebo and those with high antibody response was maintained (difference 20.2%, P = 0.012). CONCLUSIONS: Whereas Nicotine-Qbeta did not significantly increase continuous abstinence rates in the intention-to-treat population, subgroup analyses of the per-protocol population suggest that such a vaccination against nicotine can significantly increase continuous abstinence rates in smokers when sufficiently high antibody levels are achieved. Immunotherapy might open a new avenue to the treatment of nicotine addiction. TRIAL REGISTRATION: Swiss Medical Registry 2003DR2327; ClinicalTrials.gov NCT00369616.

Peer Review status:Peer reviewedPublication status:PublishedVersion:Publisher's version Funder: Cytos Biotechnology AG   Notes:Copyright © 2008 Cornuz et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Bibliographic Details

Publisher: Public Library of Science

Publisher Website: http://www.plos.org/

Journal: PloS onesee more from them

Publication Website: http://www.plosone.org/

Issue Date: 2008


Urn: uuid:af560151-54a0-45b2-b5e6-f27504bdc266

Source identifier: 422410

Eissn: 1932-6203

Doi: https://doi.org/10.1371/journal.pone.0002547

Issn: 1932-6203 Item Description

Type: Journal article;

Language: eng

Version: Publisher's versionKeywords: Humans Nicotine Placebos Injections, Intramuscular Vaccines Double-Blind Method Smoking Cessation Adult Antibody Formation Middle Aged Female Male Tiny URL: pubs:422410


Author: Cornuz, J - - - Zwahlen, S - - - Jungi, WF - - - Osterwalder, J - - - Klingler, K - - - van Melle, G - - - Bangala, Y - - - Guess

Source: https://ora.ox.ac.uk/objects/uuid:af560151-54a0-45b2-b5e6-f27504bdc266


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