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The purpose of the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected.
This study will follow subjects that participated in the NicVAX phase III studies for a second year. These predecessor studies, Nabi-4514 (NCT#00836199) and Nabi-4515 (NCT#01102114) evaluate the efficacy and safety of 6 vaccinations of NicVAX or placebo as an aid to smoking cessation. The two phase III studies are one year in duration, and subjects who complete these studies are eligible to enroll in Nabi-4522. As the phase III studies are ongoing, subject assignment to NicVAX or placebo will remain masked. No intervention will be administered in Nabi-4522. Subjects will be followed for immunogenicity (anti-nicotine antibody level)and for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NicVAX | NicVAX vaccine |
| |
| Placebo vaccine | Placebo vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicVAX vaccine | Biological | Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Levels | Analyze blood samples to determine nicotine antibody levels. | 24 months after the initial injection |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by serious adverse events | Evaluate serious adverse events | 18 months after the initial injection |
| Safety as measured by serious adverse events | Evaluate serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be invited into this study following their participation in Nabi-4514 or Nabi-4515.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Nabi Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NicVAX Investigator | Newport Beach | California | United States | |||
| NicVAX Investigator |
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serum samples
| Placebo | Biological | Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522. |
|
| 24 months after the initial injection |
| Antibody Levels | Analyze blood samples to determine nicotine antibody levels | 18 months after the initial injection |
| San Diego |
| California |
| United States |
| NicVAX Investigator | Miami | Florida | United States |
| NicVAX Investigator | Boise | Idaho | United States |
| NicVAX Investigator | Lexington | Kentucky | United States |
| NicVAX Investigator | College Park | Maryland | United States |
| NicVAX Investigator | Boston | Massachusetts | United States |
| NicVAX Investigator | Rochester | New York | United States |
| NicVAX Investigator | Raleigh | North Carolina | United States |
| NicVAX Investigator | Portland | Oregon | United States |
| NicVAX Investigator | Norfolk | Virginia | United States |
| NicVAX Investigator | Seattle | Washington | United States |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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