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OpenTrials
Completed

NCT Number: NCT00218413

Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.

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Key information

Conditions

Smoking Cessation Behavior Behavior, Addictive Compulsive Behavior Health Behavior Impulsive Behavior Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Maastricht

Maastricht, 6229 HA, Netherlands

About this study

Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current smoker
  • Good general health, including mental health
  • Alveolar carbon monoxide level greater than or equal to 10 ppm

Exclusion criteria

  • Prior exposure to NicVAX
  • Known allergy to any of the components of NicVAX
  • Use of any smoking cessation aide
  • Pregnant or breastfeeding

Treatment and study plan

NicVAX

Biological

100 μg, Formulation A, on Days 0, 21, 42, 91 & 182

Other names: 3'-aminomethylnicotine-rEPA conjugate vaccine

Primary outcomes

  1. Anti-nicotine Antibody concentrations

    Time frame: 19 time points from Day 0 to 365

Secondary outcomes

  1. Smoking cessation

    Time frame: periods of 2 weeks, 4 weeks, or 12 weeks duration

  2. Fagerstrom Test for Nicotine Dependence

    Time frame: 7 time points from Day 0 to 365

  3. Safety: vaccine reactogenicity

    Time frame: 7 days after each dose

  4. Safety: adverse events

    Time frame: Day 0-365

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jan 12, 2017

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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