NCT00218413

Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Smoking Cessation
• Tobacco Use Cessation

Interventions

Type	Name	Description
BIOLOGICAL	NicVAX	100 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
BIOLOGICAL	NicVAX	200 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
BIOLOGICAL	NicVAX	200 μg, Formulation B, on Days 0, 21, 42m 91 \& 182
BIOLOGICAL	NicVAX	300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
BIOLOGICAL	NicVAX	400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-09-22
• Last updated: 2017-01-12

Locations

1 site across 1 country: Netherlands