Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.

Official Title
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A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation

Conditions
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Smoking Behavior, Smoking Lapse Behavior, Smoking Relapse Behavior

Intervention / Treatment
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* Biological: NicVAX vaccine
* Biological: Placebo
* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokes at least 10 cigarettes per day Good general health Negative pregnancy test prior to study entry Exclusion Criteria: Prior exposure to NicVAX or any other nicotine vaccine Known allergic reaction to alum or any of the components of the vaccine Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response Cancer or cancer treatment in the last 5 years HIV infection History of drug or alcohol abuse or dependence within 12 months Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease Previous intolerance to varenicline Inability to fulfill all visits for approximately 54 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NicVAX conjugate vaccine<br> | Biological: NicVAX vaccine<br>* NicVAX vaccine given 6 times over 6 months<br>Drug: Varenicline<br>* Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)<br>* Other names: Chantix;|
| Placebo Comparator: Placebo<br>Biological | Biological: Placebo<br>* Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months<br>Drug: Varenicline<br>* Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term abstinence |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, immunogenicity |  | continuous assessment throughout the one year study duration | 
| Abstinence |  | continuous assessment throughout the one year study duration | 
| Lapse and relapse rate |  | continuous assessment throughout the one year study duration | 
| Withdrawal symptoms |  | continuous assessment throughout the one year study duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Smoking lapse behavior, Smoking Relapse behavior, Varenicline, Nicotine conjugate vaccine, Medication effect on smoking lapse behavior