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| ID | Type | Description | Link |
|---|---|---|---|
| Nabi-4505 | |||
| R01-17894-2 | |||
| DPMC |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Experimental |
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| 3 | Experimental |
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| 4 | Experimental |
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| 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicVAX | Biological | 100 μg, Formulation A, on Days 0, 21, 42, 91 & 182 |
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| Measure | Description | Time Frame |
|---|---|---|
| Anti-nicotine Antibody concentrations | 19 time points from Day 0 to 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation | periods of 2 weeks, 4 weeks, or 12 weeks duration | |
| Fagerstrom Test for Nicotine Dependence | 7 time points from Day 0 to 365 | |
| Safety: vaccine reactogenicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Horwith | Nabi Biopharmaceuticals | Principal Investigator |
| Arjen De Vos, MD, PhD | Nabi Biopharmaceuticals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maastricht | Maastricht | 6229 HA | Netherlands |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| ID | Term |
|---|---|
| C557119 | NicVAX |
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| NicVAX | Biological | 200 μg, Formulation A, on Days 0, 21, 42, 91 & 182 |
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| NicVAX | Biological | 200 μg, Formulation B, on Days 0, 21, 42m 91 & 182 |
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| NicVAX | Biological | 300 μg, Formulation B, on Days 0, 21, 42, 91 & 182 |
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| NicVAX | Biological | 400 μg, Formulation B, on Days 0, 21, 42, 91 & 182 |
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| 7 days after each dose |
| Safety: adverse events | Day 0-365 |