Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
Phase 2
Completed
- Conditions
- Smoking BehaviorSmoking Lapse BehaviorSmoking Relapse Behavior
- Interventions
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie NicVAX's nicotine receptor modulation when co-administered with varenicline (Champix)?
How effective is NicVAX plus varenicline compared to standard-of-care therapies like NRT or bupropion for smoking cessation?
Which biomarkers correlate with sustained abstinence in NicVAX and varenicline combination therapy for nicotine dependence?
What adverse events are associated with NicVAX and varenicline co-administration, and how are they managed in clinical practice?
What are the competitive nicotine vaccine candidates in development, and how do their mechanisms differ from NicVAX in combination with varenicline?
Trial Locations
- Locations (2)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands
Slotervaart Hospital/ Smoking Cessation Clinic
🇳🇱Amsterdam, Noord-Holland, Netherlands
Maastricht University Medical Center🇳🇱Maastricht, Limburg, Netherlands