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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01102114
First received: March 17, 2010
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation). [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Evaluate safety based on adverse events. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Evaluate immunology based on serum antibody concentration. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report). [ Time Frame: One year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102114

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

No publications provided

Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01102114     History of Changes
Other Study ID Numbers: Nabi-4515
Study First Received: March 17, 2010
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:
Smoking Cessation
NicVAX
Smoking Vaccine
 Smoking Abstinence
Smoking
Tobacco Cessation

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013