Evidence map›Paper›PMID 21270788›Full record

Trial reportClinical pharmacology and therapeutics2011

Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic.

D K Hatsukami, D E Jorenby, D Gonzales, N A Rigotti, E D Glover, C A Oncken, D P Tashkin, V I Reus, R C Akhavain, R E F Fahim and 4 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 102 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Nicotine vaccines for smoking cessation.The Cochrane database of systematic reviews · 2012
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. NICBrain sciences · 2025
    Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Smoking cessation and vaccination.European respiratory review : an official journal of the European Respiratory Society · 2023
    Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article

42 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

14 authors.

D K HatsukamiDepartment of Psychiatry, University of Minnesota Tobacco Use Programs, Minneapolis, Minnesota, USA. hatsu001@umn.edu
D E Jorenby
D Gonzales
N A Rigotti
E D Glover
C A Oncken
D P Tashkin
V I Reus
R C Akhavain
R E F Fahim
P D Kessler
M Niknian
M W Kalnik
S I Rennard

Funding

Efficacy of a Nicotine Vaccine for Smoking CessationR01DA017894 · NIDA · NABI BIOPHARMACEUTICALS · PI HOHENBOKEN, MATTHEW · 2005 to 2007
$4.0M
NIDA NIH HHS 1R01DA017894-01A1NIDA NIH HHS R01 DA017894
6 · The paper itself

Abstract

NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response. This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-µg doses administered four or five times over a period of 6 months, as compared with placebo. 3'AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26. The five-injection, 400-µg dose regimen elicited the greatest Ab response and resulted in significantly higher abstinence rates than placebo. This study demonstrates, as proof of concept, that 3'AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.

Indexed as

AdultAntibodiesArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedNicotineSmoking CessationTobacco Use DisorderTreatment OutcomeVaccinesVaccines, ConjugateAntibodiesNicotineNicVAXVaccinesVaccines, Conjugate

Identifiers

PMID21270788
PMCPMC4106715

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.