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OpenTrials
Completed

NCT Number: NCT00995033

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

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.

Completed

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Key information

Conditions

Smoking Behavior Behavior Health Behavior Smoking Smoking Cessation Smoking Lapse Behavior Smoking Relapse Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NicVAX Vaccine

Biological

NicVAX vaccine given 6 times over 6 months

Placebo

Biological

Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months

Varenicline

Drug

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

Primary outcomes

  1. Long term abstinence

    Time frame: one year

Secondary outcomes

  1. Safety, immunogenicity

    Time frame: continuous assessment throughout the one year study duration

  2. Abstinence

    Time frame: continuous assessment throughout the one year study duration

  3. Lapse and relapse rate

    Time frame: continuous assessment throughout the one year study duration

  4. Withdrawal symptoms

    Time frame: continuous assessment throughout the one year study duration

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Nabi Biopharmaceuticals
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2009
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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