Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Smoking Cessation, Tobacco Use Cessation

Intervention / Treatment
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* Biological: NicVAX
* Biological: NicVAX
* Biological: NicVAX
* Biological: NicVAX
* Biological: NicVAX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: NicVAX<br>* 100 μg, Formulation A, on Days 0, 21, 42, 91 & 182<br>* Other names: 3'-aminomethylnicotine-rEPA conjugate vaccine;|
| Experimental: 2<br> | Biological: NicVAX<br>* 200 μg, Formulation A, on Days 0, 21, 42, 91 & 182<br>* Other names: 3'-aminomethylnicotine-rEPA conjugate vaccine;|
| Experimental: 3<br> | Biological: NicVAX<br>* 200 μg, Formulation B, on Days 0, 21, 42m 91 & 182<br>* Other names: 3'-aminomethylnicotine-rEPA conjugate vaccine;|
| Experimental: 4<br> | Biological: NicVAX<br>* 300 μg, Formulation B, on Days 0, 21, 42, 91 & 182<br>* Other names: 3'-aminomethylnicotine-rEPA conjugate vaccine;|
| Experimental: 5<br> | Biological: NicVAX<br>* 400 μg, Formulation B, on Days 0, 21, 42, 91 & 182<br>* Other names: 3'-aminomethylnicotine-rEPA conjugate vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-nicotine Antibody concentrations |  | 19 time points from Day 0 to 365 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Immunogenicity, Randomized Controlled Trial, Addiction