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

Détails

Ressource 1Télécharger: BIB_8F009AABF3A7.P001.pdf (249.04 [Ko])
Etat: Serval
Version: de l'auteur
ID Serval
serval:BIB_8F009AABF3A7
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
A vaccine against nicotine for smoking cessation: a randomized controlled trial.
Périodique
PloS One
Auteur(s)
Cornuz Jacques, Zwahlen Susanne, Jungi Walter Felix, Osterwalder Joseph, Klingler Karl, van Melle Guy, Bangala Yolande, Guessous Idris, Mueller Philipp, Willers Joerg, Maurer Patrik, Bachmann Martin F., Cerny Thomas
ISSN
1932-6203[electronic]
Statut éditorial
Publié
Date de publication
2008
Peer-reviewed
Oui
Volume
3
Numéro
6
Pages
2547
Langue
anglais
Notes
Publication Status: epublish
Résumé
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.
Mots-clé
Adult, Antibody Formation, Double-Blind Method, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Nicotine/immunology, Placebos, Smoking Cessation/methods, Vaccines/administration & dosage, Vaccines/immunology
Pubmed
Web of science
Open Access
Oui
Création de la notice
22/01/2009 14:34
Dernière modification de la notice
08/05/2019 21:54
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