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A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01102114
First Posted: April 12, 2010
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.
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 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 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

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 (by subject self-report and carbon monoxide confirmation). [ Time Frame: One year ]

Secondary Outcome Measures:
  • Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation). [ Time Frame: One year ]
  • Evaluate safety based on adverse events. [ Time Frame: One year ]
  • Evaluate immunology based on serum antibody concentration. [ Time Frame: One year ]
  • Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report). [ Time Frame: One year ]

Enrollment: 1000
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: November 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 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.
  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): NCT01102114


  Show 25 Study Locations
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Study Director: Medical Monitor Nabi Biopharmaceuticals
  More Information

Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01102114     History of Changes
Other Study ID Numbers: Nabi-4515
First Submitted: March 17, 2010
First Posted: April 12, 2010
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