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Cited by 282Smoking Behavior and CessationMonoclonal and Polyclonal Antibodies ResearchSubstance Abuse Treatment and Outcomes

The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.

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

Open access
Cornuz, Jacques, Zwahlen, Susanne, Jungi, Walter Felix, Osterwalder, Joseph, Klingler, Karl, van Melle, Guy, Bangala, Yolande, Guessous, Idris, Müller, Philipp, Willers, Jörg, Maurer, Patrik, Bachmann, Martin F., Cerny, Thomas·2008·PLoS ONE
DOI 10.1371/journal.pone.0002547PMC PMC2432028
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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.

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Figures

Figure 1 Flow Chart of Study Subjects.
Figure 1 Flow Chart of Study Subjects.CC BY · PubMed Central
Figure 2 Geometric mean nicotine-specific IgG titers (±95% CI) (Active, N = 227; placebo, N = 108).
Figure 2 Geometric mean nicotine-specific IgG titers (±95% CI) (Active, N = 227; placebo, N = 108).CC BY · PubMed Central
Figure 3 Nicotine-specific geometric mean IgG titers (±95 confidence interval) in the per protocol population (N = 229).
Figure 3 Nicotine-specific geometric mean IgG titers (±95 confidence interval) in the per protocol population (N = 229).CC BY · PubMed Central
Figure 4 Point prevalence of smoking abstinence per antibody responder group.
Figure 4 Point prevalence of smoking abstinence per antibody responder group.CC BY · PubMed Central
Figure 5 Mean daily number of cigarettes smoked by non-abstainers per antibody responder group at the respective visit.
Figure 5 Mean daily number of cigarettes smoked by non-abstainers per antibody responder group at the respective visit.CC BY · PubMed Central

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Metadata

Authors
Cornuz, J., Zwahlen, S., Jungi, W. F., Osterwalder, J., Klingler, K., van Melle, G., Bangala, Y., Guessous, I., Müller, P., Willers, J., Maurer, P., Bachmann, M. F., & Cerny, T.
Affiliations
  • Centre Hospitalier Universitaire Vaudois (CH)
  • Kantonsspital St. Gallen (CH)
Corresponding author
Cornuz, Jacques
ORCID
Venue
PLoS ONE
Publisher
Public Library of Science (PLoS)
Published
2008-06-25
Volume
3
Issue
6
Pages
e2547
ISSN
1932-6203 (ISSN-L)
DOI
10.1371/journal.pone.0002547
PMC
PMC2432028
OpenAlex
W2069871552
Cited by
281
References
28
Citations by year
2026: 9 · 2025: 7 · 2024: 5 · 2023: 10 · 2022: 9 · 2021: 11 · 2020: 15 · 2019: 11 · 2018: 13 · 2017: 21 · 2016: 18 · 2015: 25 · 2014: 14 · 2013: 27 · 2012: 19
FWCI
15.16
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS ONE (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Figshare (submittedVersion, cc-by)
  • IRIS (submittedVersion)
  • RePEc: Research Papers in Economics (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • SERVAL (Université de Lausanne) (submittedVersion, other-oa)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
  • Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Keywords
nicotine vaccine, smoking cessation, nicotine dependence, tobacco dependence, antibody response, immunotherapy, continuous abstinence, behavioral counseling, vaccine safety
MeSH terms
Adult, Antibody Formation, Double-Blind Method, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Nicotine, Placebos, Vaccines, Smoking Cessation

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