A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation
A Second 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
1 other identifier
interventional
1,000
1 country
25
Brief Summary
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2010
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
April 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMay 9, 2012
May 1, 2012
1.7 years
March 17, 2010
May 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation).
One year
Secondary Outcomes (4)
Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation).
One year
Evaluate safety based on adverse events.
One year
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
Study Arms (2)
Placebo Vaccine
PLACEBO COMPARATORNicVAX Vaccine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior exposure to NicVAX or any other nicotine vaccine.
- Use of systemic steroids.
- Cancer or cancer treatment in the 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
NicVAX Investigator
Encino, California, United States
NicVAX Investigator
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Nabi Biopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2010
First Posted
April 12, 2010
Study Start
March 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
May 9, 2012
Record last verified: 2012-05