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Completed

NCT Number: NCT01102114

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

The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Tobacco Use Cessation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NicVAX Investigator, Encino, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

NicVAX Vaccine

Biological

NicVAX vaccine given 6 times over 6 months

Placebo vaccine

Biological

Placebo vaccine given 6 times over 6 months

Primary outcomes

  1. 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 outcomes

  1. Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation).

    Time frame: One year

  2. Evaluate safety based on adverse events.

    Time frame: One year

  3. Evaluate immunology based on serum antibody concentration.

    Time frame: One year

  4. Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report).

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 12, 2010
Registry last updated
May 9, 2012

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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