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

Smoking Behavior Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995033
• Other study ID #: MEC 08-5-066
• Secondary ID: ZonMw 40-00812-9
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2009
• Last updated: February 18, 2013
• Start date: October 2009
• Est. completion date: September 2012

Study information

• Verified date: February 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and SportUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Behavior
• Smoking Lapse Behavior
• Smoking Relapse Behavior

Intervention

Biological:
• NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
• Placebo
Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses 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)

Locations

Country	Name	City	State
Netherlands	Slotervaart Hospital/ Smoking Cessation Clinic	Amsterdam	Noord-Holland
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Nabi Biopharmaceuticals, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term abstinence		one year	No
Secondary	Safety, immunogenicity		continuous assessment throughout the one year study duration	Yes
Secondary	Abstinence		continuous assessment throughout the one year study duration	No
Secondary	Lapse and relapse rate		continuous assessment throughout the one year study duration	No
Secondary	Withdrawal symptoms		continuous assessment throughout the one year study duration	Yes