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
  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:


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 April 17, 2014