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.
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U2 - 10.1016/j.clpt.2005.08.007
DO - 10.1016/j.clpt.2005.08.007
M3 - Article
C2 - 16321612
AN - SCOPUS:28144465243
SN - 0009-9236
VL - 78
SP - 456
EP - 467
JO - Clinical pharmacology and therapeutics
JF - Clinical pharmacology and therapeutics
IS - 5
ER -
