- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00836199
NicVAX/Placebo as an Aid for Smoking Cessation
May 8, 2012 updated by: Nabi Biopharmaceuticals
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States
- NicVAX Investigator
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California
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Los Angeles, California, United States
- NicVAX Investigator
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Newport Beach, California, United States
- NicVAX Investigator
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San Diego, California, United States
- NicVAX Investigator
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Colorado
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Denver, Colorado, United States
- NicVAX Investigator
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Connecticut
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Farmington, Connecticut, United States
- NicVAX Investigator
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Florida
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Miami, Florida, United States
- NicVAX Investigator
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St. Petersburg, Florida, United States
- NicVAX Investigator
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Idaho
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Boise, Idaho, United States
- NicVAX Investigator
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Kentucky
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Lexington, Kentucky, United States
- NicVAX Investigator
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Maryland
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Baltimore, Maryland, United States
- NicVAX Investigator
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College Park, Maryland, United States
- NicVAX Investigator
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Massachusetts
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Boston, Massachusetts, United States
- NicVAX Investigator
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Minnesota
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Minneapolis, Minnesota, United States
- NicVAX Investigator
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Nebraska
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Omaha, Nebraska, United States
- NicVAX Investigator
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New York
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Rochester, New York, United States
- NicVAX Investigator
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North Carolina
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Raleigh, North Carolina, United States
- NicVAX Investigator
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Oregon
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Portland, Oregon, United States
- NicVAX Investigator
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Utah
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Draper, Utah, United States
- NicVAX Investigator
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Virginia
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Norfolk, Virginia, United States
- NicVAX Investigator
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Washington
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Seattle, Washington, United States
- NicVAX Investigator
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Wisconsin
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Madison, Wisconsin, United States
- NicVAX Investigator
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
- Smokers who are in good general health.
Exclusion Criteria:
- Prior exposure to NicVAX or any other nicotine vaccine.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo vaccine
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Placebo vaccine given 6 times over 6 months
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Experimental: NicVAX vaccine
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NicVAX vaccine given 6 times over 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate abstinence rates at multiple intervals
Time Frame: multiple time points
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multiple time points
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Evaluate safety and immunogenicity
Time Frame: mulitple time points
|
mulitple time points
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Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.
Time Frame: multiple time points
|
multiple time points
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 3, 2009
First Submitted That Met QC Criteria
February 3, 2009
First Posted (Estimate)
February 4, 2009
Study Record Updates
Last Update Posted (Estimate)
May 9, 2012
Last Update Submitted That Met QC Criteria
May 8, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nabi-4514
- NIH grant # 1 RC2 DA028837-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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