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NicVAX/Placebo as an Aid for Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836199
First Posted: February 4, 2009
Last Update Posted: May 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
  Purpose
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

Condition Intervention Phase
Smoking Cessation Smoking Tobacco Cessation Biological: NicVAX vaccine Biological: Placebo vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Evaluate NicVAX as an aid to smoking cessation for long term abstinence. [ Time Frame: one year ]

Secondary Outcome Measures:
  • Evaluate abstinence rates at multiple intervals [ Time Frame: multiple time points ]
  • Evaluate safety and immunogenicity [ Time Frame: mulitple time points ]
  • Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence. [ Time Frame: multiple time points ]

Enrollment: 1000
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo vaccine Biological: Placebo vaccine
Placebo vaccine given 6 times over 6 months
Experimental: NicVAX vaccine Biological: NicVAX vaccine
NicVAX vaccine given 6 times over 6 months

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836199


  Hide Study Locations
Locations
United States, Arizona
NicVAX Investigator
Tucson, Arizona, United States
United States, California
NicVAX Investigator
Los Angeles, California, United States
NicVAX Investigator
Newport Beach, California, United States
NicVAX Investigator
San Diego, California, United States
United States, Colorado
NicVAX Investigator
Denver, Colorado, United States
United States, Connecticut
NicVAX Investigator
Farmington, Connecticut, United States
United States, Florida
NicVAX Investigator
Miami, Florida, United States
NicVAX Investigator
St. Petersburg, Florida, United States
United States, Idaho
NicVAX Investigator
Boise, Idaho, United States
United States, Kentucky
NicVAX Investigator
Lexington, Kentucky, United States
United States, Maryland
NicVAX Investigator
Baltimore, Maryland, United States
NicVAX Investigator
College Park, Maryland, United States
United States, Massachusetts
NicVAX Investigator
Boston, Massachusetts, United States
United States, Minnesota
NicVAX Investigator
Minneapolis, Minnesota, United States
United States, Nebraska
NicVAX Investigator
Omaha, Nebraska, United States
United States, New York
NicVAX Investigator
Rochester, New York, United States
United States, North Carolina
NicVAX Investigator
Raleigh, North Carolina, United States
United States, Oregon
NicVAX Investigator
Portland, Oregon, United States
United States, Utah
NicVAX Investigator
Draper, Utah, United States
United States, Virginia
NicVAX Investigator
Norfolk, Virginia, United States
United States, Washington
NicVAX Investigator
Seattle, Washington, United States
United States, Wisconsin
NicVAX Investigator
Madison, Wisconsin, United States
Sponsors and Collaborators
Nabi Biopharmaceuticals
National Institute on Drug Abuse (NIDA)
Investigators
Study Director: Medical Monitor Nabi Biopharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00836199     History of Changes
Other Study ID Numbers: Nabi-4514
NIH grant # 1 RC2 DA028837-01
First Submitted: February 3, 2009
First Posted: February 4, 2009
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Nabi Biopharmaceuticals:
smoking cessation
NicVAX
smoking vaccine
smoking abstinence
smoking
tobacco cessation

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs