Evidence map›Paper›PMID 18575629›Full record

Trial reportPloS one2008

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

Jacques Cornuz, Susanne Zwahlen, Walter Felix Jungi, Joseph Osterwalder, Karl Klingler, Guy van Melle, Yolande Bangala, Idris Guessous, Philipp Müller, Jörg Willers and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00369616 (Evaluation of Efficacy and Safety of Nicotine-Qbeta), which is not on this map. Cited by 140 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
140citing papers in PubMed, 2 pooled it
12.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00369616 phase2completednot on this map

Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers

TypeinterventionalSponsorCytos Biotechnology AGRan2003 to 2005Enrolled341ConditionsSmokersArmsCYT002-NicQb
3 · Its place in the literature

Who cites it

140 citing papers in PubMed, 2 syntheses or guidelines pooled it, 282 citations in OpenAlex.

  1. Pooled it
  2. Nicotine vaccines for smoking cessation.The Cochrane database of systematic reviews · 2012
    Pooled it
  3. Development of an Interleukin-1β Vaccine in Patients with Type 2 Diabetes.Molecular therapy : the journal of the American Society of Gene Therapy · 2016
    Trial
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  8. NICBrain sciences · 2025
    Article
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  12. Review
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80 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Jacques CornuzDepartment of Internal Medicine, Lausanne University Hospital, Lausanne, Switzerland. Jacques.Cornuz@chuv.ch
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
Kantonsspital St. Gallen · CHUniversity of Lausanne · CHKlinik Hirslanden · CHUniversity Hospital of Lausanne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTobacco 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

findings229 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).

conclusionsWhereas 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 registrationSwiss Medical Registry 2003DR2327; ClinicalTrials.gov NCT00369616.

Indexed as

AdultAntibody FormationDouble-Blind MethodFemaleHumansInjections, IntramuscularMaleMiddle AgedNicotinePlacebosSmoking CessationVaccinesNicotinePlacebosVaccines

Identifiers

PMID18575629
PMCPMC2432028
OpenAlexW2069871552

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.