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The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Vaccine | Placebo Comparator |
| |
| NicVAX Vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicVAX Vaccine | Biological | NicVAX vaccine given 6 times over 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation). | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation). | One year | |
| Evaluate safety based on adverse events. | One year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Nabi Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NicVAX Investigator | Encino | California | United States | |||
| NicVAX Investigator |
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| Placebo Vaccine |
| Biological |
Placebo vaccine given 6 times over 6 months |
|
| Evaluate immunology based on serum antibody concentration. |
| One year |
| Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report). | One year |
| Los Alamitos |
| California |
| United States |
| NicVAX Investigator | Denver | Colorado | United States |
| NicVAX Investigator | New Haven | Connecticut | United States |
| NicVAX Investigator | Brooksville | Florida | United States |
| NicVAX Investigator | Orlando | Florida | United States |
| NicVAX Investigator | Pembroke Pines | Florida | United States |
| NicVAX Investigator | Tampa | Florida | United States |
| NicVAX Investigator | Indianapolis | Indiana | United States |
| NicVAX Investigator | Wichita | Kansas | United States |
| NicVAX Investigator | Metairie | Louisiana | United States |
| NicVAX Investigator | Annapolis | Maryland | United States |
| NicVAX Investigator | Milford | Massachusetts | United States |
| NicVAX Investigator | East Lansing | Michigan | United States |
| NicVAX Investigator | Rochester | Minnesota | United States |
| NicVAX Investigator | Jackson | Mississippi | United States |
| NicVAX Investigator | Omaha | Nebraska | United States |
| NicVAX Investigator | Buffalo | New York | United States |
| NicVAX Investigator | Cincinnati | Ohio | United States |
| NicVAX Investigator | Mt. Pleasant | South Carolina | United States |
| NicVAX Investigator | Knoxville | Tennessee | United States |
| NicVAX Investigator | Nashville | Tennessee | United States |
| NicVAX Investigator | Houston | Texas | United States |
| NicVAX Investigator | Salt Lake City | Utah | United States |
| NicVAX Investigator | Charleston | West Virginia | United States |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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