A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers
Sponsor study identifier
Secondary identifiers
interventional
51
1 country
1
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2006
Actual (reported)Study Completion
August 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 16, 2005
Actual (reported)September 22, 2005
Actual (reported)August 2006
Actual (reported)August 2006
Actual (reported)Anti-nicotine Antibody concentrations
19 time points from Day 0 to 365
Smoking cessation
periods of 2 weeks, 4 weeks, or 12 weeks duration
Fagerstrom Test for Nicotine Dependence
7 time points from Day 0 to 365
Safety: vaccine reactogenicity
7 days after each dose
Safety: adverse events
Day 0-365
100 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
200 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
University of Maastricht
Maastricht, 6229 HA, Netherlands
Gary Horwith
Nabi Biopharmaceuticals
Arjen De Vos, MD, PhD
Nabi Biopharmaceuticals
51 participants (actual enrollment reported by the registry).
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Pilot Study of a New Nicotine Replacement Therapy
200 μg, Formulation B, on Days 0, 21, 42m 91 \& 182
300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2006
Actual (reported)Study Completion
August 2006
Actual (reported)Last Updated
January 12, 2017
Record last verified: 2008-11
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Source: ClinicalTrials.gov.
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