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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00995033

Enrollment

558

Registered

2009-10-14

Start date

2009-10-31

Completion date

2012-09-30

Last updated

2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BIOLOGICALNicVAX vaccine

NicVAX vaccine given 6 times over 6 months

BIOLOGICALPlacebo

Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months

DRUGVarenicline

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Long term abstinence	one year

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026