Safety and immunogenicity of a nicotine conjugate vaccine in current smokers

Dorothy K. Hatsukami, Stephen Rennard, Douglas Jorenby, Michael Fiore, Joseph Koopmeiners, Arjen De Vos, Gary Horwith, Paul R. Pentel

Research output: Contribution to journalArticle

155 Citations (Scopus)

Abstract

Immunotherapy is a novel potential treatment for nicotine addiction. The aim of this study was to assess the safety and immunogenicity of a nicotine conjugate vaccine, NicVAX, and its effects on smoking behavior. Smokers (N = 68) were recruited for a noncessation treatment study and assigned to 1 of 3 doses of the nicotine vaccine (50, 100, or 200 μg) or placebo. They were injected on days 0, 28, 56, and 182 and monitored for a period of 38 weeks. Results showed that the nicotine vaccine was safe and well tolerated. Vaccine immunogenicity was dose-related (P < .001), with the highest dose eliciting antibody concentrations within the anticipated range of efficacy. There was no evidence of compensatory smoking or precipitation of nicotine withdrawal with the nicotine vaccine. The 30-day abstinence rate was significantly different across the 4 doses (P = .02), with the highest rate of abstinence occurring with 200 μg. The nicotine vaccine appears to be a promising medication for tobacco dependence.

Original languageEnglish (US)
Pages (from-to)456-467
Number of pages12
JournalClinical Pharmacology and Therapeutics
Volume78
Issue number5
DOIs
StatePublished - Nov 2005

Fingerprint

Conjugate Vaccines
Nicotine
Safety
Vaccines
Smoking
Tobacco Use Disorder
Immunotherapy
Placebos
Antibodies
Therapeutics

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Hatsukami, D. K., Rennard, S., Jorenby, D., Fiore, M., Koopmeiners, J., De Vos, A., ... Pentel, P. R. (2005). Safety and immunogenicity of a nicotine conjugate vaccine in current smokers. Clinical Pharmacology and Therapeutics, 78(5), 456-467. https://doi.org/10.1016/j.clpt.2005.08.007

Safety and immunogenicity of a nicotine conjugate vaccine in current smokers. / Hatsukami, Dorothy K.; Rennard, Stephen; Jorenby, Douglas; Fiore, Michael; Koopmeiners, Joseph; De Vos, Arjen; Horwith, Gary; Pentel, Paul R.

In: Clinical Pharmacology and Therapeutics, Vol. 78, No. 5, 11.2005, p. 456-467.

Research output: Contribution to journalArticle

Hatsukami, DK, Rennard, S, Jorenby, D, Fiore, M, Koopmeiners, J, De Vos, A, Horwith, G & Pentel, PR 2005, 'Safety and immunogenicity of a nicotine conjugate vaccine in current smokers', Clinical Pharmacology and Therapeutics, vol. 78, no. 5, pp. 456-467. https://doi.org/10.1016/j.clpt.2005.08.007
Hatsukami DK, Rennard S, Jorenby D, Fiore M, Koopmeiners J, De Vos A et al. Safety and immunogenicity of a nicotine conjugate vaccine in current smokers. Clinical Pharmacology and Therapeutics. 2005 Nov;78(5):456-467. https://doi.org/10.1016/j.clpt.2005.08.007
Hatsukami, Dorothy K. ; Rennard, Stephen ; Jorenby, Douglas ; Fiore, Michael ; Koopmeiners, Joseph ; De Vos, Arjen ; Horwith, Gary ; Pentel, Paul R. / Safety and immunogenicity of a nicotine conjugate vaccine in current smokers. In: Clinical Pharmacology and Therapeutics. 2005 ; Vol. 78, No. 5. pp. 456-467.
@article{43140ad8dc1c455fb5630e1284ab6dec,
title = "Safety and immunogenicity of a nicotine conjugate vaccine in current smokers",
abstract = "Immunotherapy is a novel potential treatment for nicotine addiction. The aim of this study was to assess the safety and immunogenicity of a nicotine conjugate vaccine, NicVAX, and its effects on smoking behavior. Smokers (N = 68) were recruited for a noncessation treatment study and assigned to 1 of 3 doses of the nicotine vaccine (50, 100, or 200 μg) or placebo. They were injected on days 0, 28, 56, and 182 and monitored for a period of 38 weeks. Results showed that the nicotine vaccine was safe and well tolerated. Vaccine immunogenicity was dose-related (P < .001), with the highest dose eliciting antibody concentrations within the anticipated range of efficacy. There was no evidence of compensatory smoking or precipitation of nicotine withdrawal with the nicotine vaccine. The 30-day abstinence rate was significantly different across the 4 doses (P = .02), with the highest rate of abstinence occurring with 200 μg. The nicotine vaccine appears to be a promising medication for tobacco dependence.",
author = "Hatsukami, {Dorothy K.} and Stephen Rennard and Douglas Jorenby and Michael Fiore and Joseph Koopmeiners and {De Vos}, Arjen and Gary Horwith and Pentel, {Paul R.}",
year = "2005",
month = "11",
doi = "10.1016/j.clpt.2005.08.007",
language = "English (US)",
volume = "78",
pages = "456--467",
journal = "Clinical Pharmacology and Therapeutics",
issn = "0009-9236",
publisher = "Nature Publishing Group",
number = "5",

}

TY - JOUR

T1 - Safety and immunogenicity of a nicotine conjugate vaccine in current smokers

AU - Hatsukami, Dorothy K.

AU - Rennard, Stephen

AU - Jorenby, Douglas

AU - Fiore, Michael

AU - Koopmeiners, Joseph

AU - De Vos, Arjen

AU - Horwith, Gary

AU - Pentel, Paul R.

PY - 2005/11

Y1 - 2005/11

N2 - Immunotherapy is a novel potential treatment for nicotine addiction. The aim of this study was to assess the safety and immunogenicity of a nicotine conjugate vaccine, NicVAX, and its effects on smoking behavior. Smokers (N = 68) were recruited for a noncessation treatment study and assigned to 1 of 3 doses of the nicotine vaccine (50, 100, or 200 μg) or placebo. They were injected on days 0, 28, 56, and 182 and monitored for a period of 38 weeks. Results showed that the nicotine vaccine was safe and well tolerated. Vaccine immunogenicity was dose-related (P < .001), with the highest dose eliciting antibody concentrations within the anticipated range of efficacy. There was no evidence of compensatory smoking or precipitation of nicotine withdrawal with the nicotine vaccine. The 30-day abstinence rate was significantly different across the 4 doses (P = .02), with the highest rate of abstinence occurring with 200 μg. The nicotine vaccine appears to be a promising medication for tobacco dependence.

AB - Immunotherapy is a novel potential treatment for nicotine addiction. The aim of this study was to assess the safety and immunogenicity of a nicotine conjugate vaccine, NicVAX, and its effects on smoking behavior. Smokers (N = 68) were recruited for a noncessation treatment study and assigned to 1 of 3 doses of the nicotine vaccine (50, 100, or 200 μg) or placebo. They were injected on days 0, 28, 56, and 182 and monitored for a period of 38 weeks. Results showed that the nicotine vaccine was safe and well tolerated. Vaccine immunogenicity was dose-related (P < .001), with the highest dose eliciting antibody concentrations within the anticipated range of efficacy. There was no evidence of compensatory smoking or precipitation of nicotine withdrawal with the nicotine vaccine. The 30-day abstinence rate was significantly different across the 4 doses (P = .02), with the highest rate of abstinence occurring with 200 μg. The nicotine vaccine appears to be a promising medication for tobacco dependence.

UR - http://www.scopus.com/inward/record.url?scp=28144465243&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=28144465243&partnerID=8YFLogxK

U2 - 10.1016/j.clpt.2005.08.007

DO - 10.1016/j.clpt.2005.08.007

M3 - Article

C2 - 16321612

AN - SCOPUS:28144465243

VL - 78

SP - 456

EP - 467

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

SN - 0009-9236

IS - 5

ER -