Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)

Phase 2

Completed

• Conditions: Smoking Behavior; Smoking Lapse Behavior; Smoking Relapse Behavior
• Interventions: Biological: NicVAX vaccine; Biological: Placebo; Drug: Varenicline

• Registration Number: NCT00995033
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-12
• Study First Posted: 2009-10-14
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-18
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

Inclusion Criteria

• Smokes at least 10 cigarettes per day
• Good general health
• Negative pregnancy test prior to study entry

Exclusion Criteria

• Prior exposure to NicVAX or any other nicotine vaccine
• Known allergic reaction to alum or any of the components of the vaccine
• Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response
• 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
• Previous intolerance to varenicline
• Inability to fulfill all visits for approximately 54 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NicVAX conjugate vaccine	NicVAX vaccine	-
NicVAX conjugate vaccine	Varenicline	-
Placebo	Placebo	Biological
Placebo	Varenicline	Biological

Primary Outcome Measures

Name	Time	Method
Long term abstinence	one year

Secondary Outcome Measures

Name	Time	Method
Safety, immunogenicity	continuous assessment throughout the one year study duration
Abstinence	continuous assessment throughout the one year study duration
Lapse and relapse rate	continuous assessment throughout the one year study duration
Withdrawal symptoms	continuous assessment throughout the one year study duration

Trial Locations

Locations (2)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands

Slotervaart Hospital/ Smoking Cessation Clinic; 🇳🇱 Amsterdam, Noord-Holland, Netherlands