Antibody and Safety Study of 6 Doses of NicVAX in Smokers

Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers

Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.

Inclusion Criteria:

• Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
• Written informed consent
• Negative urine pregnancy test, and willing to use birth control during the study, if applicable

Exclusion Criteria:

• Prior exposure to nicotine vaccine
• Clinically significant allergic reactions, especially to components of the vaccine
• Serious or unstable clinical disease within the past 6 months
• Use of any smoking cessation therapy within 30 days preceding 1st dose
• Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
• Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
• Use of another IND drug or device within 30 days preceding 1st dose
• Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months