Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2009-10-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo vaccine
Placebo vaccine
Placebo vaccine given 6 times over 6 months
NicVAX vaccine
NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
Interventions
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NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
Placebo vaccine
Placebo vaccine given 6 times over 6 months
Eligibility Criteria
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Inclusion Criteria
* Smokers who are in good general health.
Exclusion Criteria
* Use of systemic steroids.
* Cancer or cancer treatment in 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.
* Inability to fulfill all visits for approximately 52 weeks.
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Nabi Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Nabi Biopharmaceuticals
Locations
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NicVAX Investigator
Tucson, Arizona, United States
NicVAX Investigator
Los Angeles, California, United States
NicVAX Investigator
Newport Beach, California, United States
NicVAX Investigator
San Diego, California, United States
NicVAX Investigator
Denver, Colorado, United States
NicVAX Investigator
Farmington, Connecticut, United States
NicVAX Investigator
Miami, Florida, United States
NicVAX Investigator
St. Petersburg, Florida, United States
NicVAX Investigator
Boise, Idaho, United States
NicVAX Investigator
Lexington, Kentucky, United States
NicVAX Investigator
Baltimore, Maryland, United States
NicVAX Investigator
College Park, Maryland, United States
NicVAX Investigator
Boston, Massachusetts, United States
NicVAX Investigator
Minneapolis, Minnesota, United States
NicVAX Investigator
Omaha, Nebraska, United States
NicVAX Investigator
Rochester, New York, United States
NicVAX Investigator
Raleigh, North Carolina, United States
NicVAX Investigator
Portland, Oregon, United States
NicVAX Investigator
Draper, Utah, United States
NicVAX Investigator
Norfolk, Virginia, United States
NicVAX Investigator
Seattle, Washington, United States
NicVAX Investigator
Madison, Wisconsin, United States
Countries
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References
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Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343.
Other Identifiers
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NIH grant # 1 RC2 DA028837-01
Identifier Type: -
Identifier Source: secondary_id
Nabi-4514
Identifier Type: -
Identifier Source: org_study_id
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