Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
University of Maastricht
Maastricht, Netherlands
Anti-nicotine Antibody concentrations
Time frame: 19 time points from Day 0 to 365
Smoking cessation
Time frame: periods of 2 weeks, 4 weeks, or 12 weeks duration
Fagerstrom Test for Nicotine Dependence
Time frame: 7 time points from Day 0 to 365
Safety: vaccine reactogenicity
Time frame: 7 days after each dose
Safety: adverse events
Time frame: Day 0-365
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300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182