Antibody and Safety Study of 6 Doses of NicVAX in Smokers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Smoking

Intervention / Treatment
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* Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)


Participation Criteria
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Eligibility Criteria
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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

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NicVAX<br> | Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)<br>* 1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)<br>* Other names: NicVAX;|
| Experimental: NicVAX Lot 2<br>2nd cohort receives a different lot of vaccine from the 1st cohort | Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)<br>* 1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)<br>* Other names: NicVAX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-nicotine antibody concentration |  | 12 time points between screening and week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine reactogenicity |  | for 7 days after each dose | 
| Adverse events |  | for 30 weeks after 1st dose (4 wk after last dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine, Vaccine, Immunogenicity, Tobacco, Habits