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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Behavior; Smoking Lapse Behavior; Smoking Relapse Behavior
• Intervention / Treatment: Biological: NicVAX vaccine; Drug: Varenicline; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Maastricht University Medical Center
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1006 BK
      • Slotervaart Hospital/ Smoking Cessation Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NicVAX conjugate vaccine	Biological: NicVAX vaccine; NicVAX vaccine given 6 times over 6 months; Drug: Varenicline; Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening); Other Names: Champix; Chantix
Placebo Comparator: Placebo; Biological	Drug: Varenicline; Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening); Other Names: Champix; Chantix; Biological: Placebo; Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long term abstinence	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Nabi Biopharmaceuticals
• Investigators: Principal Investigator: Onno van Schayck, Professor Dr, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: October 12, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 18, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Smoking cessation; Varenicline; Smoking lapse behavior; Smoking Relapse behavior; Nicotine conjugate vaccine; Medication effect on smoking lapse behavior
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: MEC 08-5-066; ZonMw 40-00812-98-07-004; ZonMw 61200014; Nabi-4508