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

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

doi:10.1371/journal.pone.0002547

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

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

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Cornuz, Jacques, Zwahlen, Susanne, Jungi, Walter Felix, Osterwalder, Joseph, Klingler, Karl, van Melle, Guy, Bangala, Yolande, Guessous, Idris +5 more·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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Early phase 1/2 clinical trials in humans have demonstrated drug safety, effective immunogenicity, and promising increases in abstinence rates, especially among individuals with higher levels of anti-nicotine IgGs.
“Early phase 1/2 clinical trials in humans have demonstrated drug safety, effective immunogenicity, and promising increases in abstinence rates, especially among individuals with higher levels of anti-nicotine IgGs [253–256].”
From Mechanistic insights into nicotine withdrawal (2011) · cites this paper as [253]

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Immunogenicity and Smoking Cessation Outcomes for a Novel Nicotine Immunotherapeutic
Oncken, C. A. (2011) · OpenCommons - UConn (University of Connecticut)
Abstract 3712: A Randomized Placebo-Controlled Trial of a Conjugate Nicotine Vaccine (NicVAX®) in Smokers Who Want to Quit: 12 Month Results
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Vaccination against nicotine: an emerging therapy for tobacco dependence
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Safety and immunogenicity of a nicotine conjugate vaccine in current smokers
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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: Cornuz, Jacques
Osterwalder, Joseph
Guessous, Idris
Müller, Philipp
Bachmann, Martin F.
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: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (unspecified)
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 › Physiology › Smoking Behavior and Cessation
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › 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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