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Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)

This study has been completed.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Nabi Biopharmaceuticals
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00995033
First received: October 6, 2009
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Condition Intervention Phase
Smoking Behavior
Smoking Lapse Behavior
Smoking Relapse Behavior
 Biological: NicVAX vaccine
Biological: Placebo
Drug: Varenicline
 Phase 2

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 Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Long term abstinence [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, immunogenicity [ Time Frame: continuous assessment throughout the one year study duration ] [ Designated as safety issue: Yes ]
  • Abstinence [ Time Frame: continuous assessment throughout the one year study duration ] [ Designated as safety issue: No ]
  • Lapse and relapse rate [ Time Frame: continuous assessment throughout the one year study duration ] [ Designated as safety issue: No ]
  • Withdrawal symptoms [ Time Frame: continuous assessment throughout the one year study duration ] [ Designated as safety issue: Yes ]

Enrollment: 558
Study Start Date: October 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NicVAX conjugate vaccine Biological: NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
Drug: Varenicline
Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)
Other Names:
  • Champix
  • Chantix
Placebo Comparator: Placebo
Biological
 Biological: Placebo
Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months
Drug: Varenicline
Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)
Other Names:
  • Champix
  • Chantix

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smokes at least 10 cigarettes per day
  • Good general health
  • Negative pregnancy test prior to study entry

Exclusion Criteria:

  • Prior exposure to NicVAX or any other nicotine vaccine
  • Known allergic reaction to alum or any of the components of the vaccine
  • Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response
  • 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
  • Previous intolerance to varenicline
  • Inability to fulfill all visits for approximately 54 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995033

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200 MD
Slotervaart Hospital/ Smoking Cessation Clinic
Amsterdam, Noord-Holland, Netherlands, 1006 BK
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Nabi Biopharmaceuticals
Investigators
Principal Investigator: Onno van Schayck, Professor Dr Maastricht University Medical Center
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00995033     History of Changes
Other Study ID Numbers: MEC 08-5-066, ZonMw 40-00812-98-07-004, ZonMw 61200014, Nabi-4508
Study First Received: October 6, 2009
Last Updated: February 18, 2013
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
United States: Food and Drug Administration

Keywords provided by Maastricht University Medical Center:
Smoking cessation
Smoking lapse behavior
Smoking Relapse behavior
 Varenicline
Nicotine conjugate vaccine
Medication effect on smoking lapse behavior

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013