A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers

The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.

Inclusion Criteria:

• Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.

Exclusion Criteria:

• Prior exposure to NicVAX or any other nicotine vaccine.
• History of clinically significant allergic reactions.
• Use of systemic steroids.
• Cancer or cancer treatment within 5 years.
• HIV infection.
• History of drug or alcohol abuse or dependence.
• Required treatment for depression within the past 12 months.
• Body mass index ≥ 30 [calculated as weight (kg)/height2 (m)].
• Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
• Inability to fulfill all visits for approximately 30 weeks.