Clinical trial NCT00995033: Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
Official title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Behavior
Smoking Lapse Behavior
Smoking Relapse Behavior
Keywords: Smoking cessation
Smoking lapse behavior
Smoking Relapse behavior
Varenicline
Nicotine conjugate vaccine
Medication effect on smoking lapse behavior
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Nabi Biopharmaceuticals
First posted: 2009-10-14
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Long term abstinence
timeFrame: one year
Secondary outcomes:
measure: Safety, immunogenicity
timeFrame: continuous assessment throughout the one year study duration
measure: Abstinence
timeFrame: continuous assessment throughout the one year study duration
measure: Lapse and relapse rate
timeFrame: continuous assessment throughout the one year study duration
measure: Withdrawal symptoms
timeFrame: continuous assessment throughout the one year study duration
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Amsterdam
country: Netherlands
facility: Slotervaart Hospital/ Smoking Cessation Clinic
state: Noord-Holland
Study officials:
affiliation: Maastricht University Medical Center
name: Onno van Schayck, Professor Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoogsteder PH, Kotz D, van Spiegel PI, Viechtbauer W, van Schayck OC. Efficacy of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) co-administered with varenicline and counselling for smoking cessation: a randomized placebo-controlled trial. Addiction. 2014 Aug;109(8):1252-9. doi: 10.1111/add.12573. Epub 2014 Jun 3.
citation: Hoogsteder PH, Kotz D, van Spiegel PI, Viechtbauer W, Brauer R, Kessler PD, Kalnik MW, Fahim RE, van Schayck OC. The efficacy and safety of a nicotine conjugate vaccine (NicVAX(R)) or placebo co-administered with varenicline (Champix(R)) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial. BMC Public Health. 2012 Dec 6;12:1052. doi: 10.1186/1471-2458-12-1052.