Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals - Full Text View

Sponsors and Collaborators:	Nabi Biopharmaceuticals National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218413

Purpose

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.

Condition	Intervention	Phase
Smoking Cessation Tobacco Use Cessation	Biological: NicVAX	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Anti-nicotine Antibody concentrations [ Time Frame: 19 time points from Day 0 to 365 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Smoking cessation [ Time Frame: periods of 2 weeks, 4 weeks, or 12 weeks duration ] [ Designated as safety issue: No ]
Fagerstrom Test for Nicotine Dependence [ Time Frame: 7 time points from Day 0 to 365 ] [ Designated as safety issue: No ]
Safety: vaccine reactogenicity [ Time Frame: 7 days after each dose ] [ Designated as safety issue: Yes ]
Safety: adverse events [ Time Frame: Day 0-365 ] [ Designated as safety issue: Yes ]

Enrollment:	51
Study Start Date:	October 2004
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: NicVAX 100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
2: Experimental	Biological: NicVAX 200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
3: Experimental	Biological: NicVAX 200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
4: Experimental	Biological: NicVAX 300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
5: Experimental	Biological: NicVAX 400 μg, Formulation B, on Days 0, 21, 42, 91 & 182

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218413

Locations

Netherlands
University of Maastricht
Maastricht, Netherlands, 6229 HA

Sponsors and Collaborators

Nabi Biopharmaceuticals

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Gary Horwith	Nabi Biopharmaceuticals
Principal Investigator:	Arjen De Vos, MD, PhD	Nabi Biopharmaceuticals

More Information

Responsible Party:	Nabi Biopharmaceuticals ( Arjen DeVos/ Senior Director, Medical Affairs and Clinical Research )
Study ID Numbers:	NIDA-17894-2, Nabi-4505, R01-17894-2, DPMC
Study First Received:	September 16, 2005
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00218413
Health Authority:	Netherlands: Independent Ethics Committee; United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Vaccine
Immunogenicity
Randomized Controlled Trial
Addiction

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Behavior, Addictive
Nicotine

ClinicalTrials.gov processed this record on January 15, 2009