Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

Phase 2

Completed

• Conditions: Tobacco Use Cessation; Smoking Cessation
• Interventions: Biological: NicVAX

• Registration Number: NCT00218413
• Lead Sponsor: Nabi Biopharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2008-11
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	NicVAX	-
2	NicVAX	-
4	NicVAX	-
3	NicVAX	-
5	NicVAX	-

Primary Outcome Measures

Name	Time	Method
Anti-nicotine Antibody concentrations	19 time points from Day 0 to 365

Secondary Outcome Measures

Name	Time	Method
Smoking cessation	periods of 2 weeks, 4 weeks, or 12 weeks duration
Fagerstrom Test for Nicotine Dependence	7 time points from Day 0 to 365
Safety: vaccine reactogenicity	7 days after each dose
Safety: adverse events	Day 0-365

Trial Locations

Locations (1)

University of Maastricht; 🇳🇱 Maastricht, Netherlands