IDEAS home Printed from https://ideas.repec.org/a/plo/pone00/0002547.html
   My bibliography  Save this article

A Vaccine against Nicotine for Smoking Cessation: A Randomized Controlled Trial

Author

Listed:
  • Jacques Cornuz
  • Susanne Zwahlen
  • Walter Felix Jungi
  • Joseph Osterwalder
  • Karl Klingler
  • Guy van Melle
  • Yolande Bangala
  • Idris Guessous
  • Philipp Müller
  • Jörg Willers
  • Patrik Maurer
  • Martin F Bachmann
  • Thomas Cerny

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-Qβ (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-Qβ 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

Suggested Citation

  • Jacques Cornuz & Susanne Zwahlen & Walter Felix Jungi & Joseph Osterwalder & Karl Klingler & Guy van Melle & Yolande Bangala & Idris Guessous & Philipp Müller & Jörg Willers & Patrik Maurer & Martin F, 2008. "A Vaccine against Nicotine for Smoking Cessation: A Randomized Controlled Trial," PLOS ONE, Public Library of Science, vol. 3(6), pages 1-10, June.
    • Handle: RePEc:plo:pone00:0002547
    DOI: 10.1371/journal.pone.0002547
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0002547
    Download Restriction: no
    File URL: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0002547&type=printable
    Download Restriction: no
    File URL: https://libkey.io/10.1371/journal.pone.0002547?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pone00:0002547. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: plosone (email available below). General contact details of provider: https://journals.plos.org/plosone/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.