Smoking Cessation Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | August 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Current smoker - Good general health, including mental health - Alveolar carbon monoxide level greater than or equal to 10 ppm Exclusion Criteria: - Prior exposure to NicVAX - Known allergy to any of the components of NicVAX - Use of any smoking cessation aide - Pregnant or breastfeeding |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | University of Maastricht | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Nabi Biopharmaceuticals | National Institute on Drug Abuse (NIDA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-nicotine Antibody concentrations | 19 time points from Day 0 to 365 | No | |
Secondary | Smoking cessation | periods of 2 weeks, 4 weeks, or 12 weeks duration | No | |
Secondary | Fagerstrom Test for Nicotine Dependence | 7 time points from Day 0 to 365 | No | |
Secondary | Safety: vaccine reactogenicity | 7 days after each dose | Yes | |
Secondary | Safety: adverse events | Day 0-365 | Yes |
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