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

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

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.

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