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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborators: Nabi Biopharmaceuticals; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Vaccines; Varenicline

Criteria

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