NCT00995033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

2.9 years

First QC Date

October 6, 2009

Last Update Submit

February 18, 2013

Conditions

Smoking BehaviorSmoking Lapse BehaviorSmoking Relapse Behavior

Keywords

Smoking cessationSmoking lapse behaviorSmoking Relapse behaviorVareniclineNicotine conjugate vaccineMedication effect on smoking lapse behavior

Outcome Measures

Primary Outcomes (1)

  • Long term abstinence

    one year

Secondary Outcomes (4)

  • 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

Study Arms (2)

NicVAX conjugate vaccine

EXPERIMENTAL
Biological: NicVAX vaccineDrug: Varenicline

Placebo

PLACEBO COMPARATOR

Biological

Biological: PlaceboDrug: Varenicline

Interventions

NicVAX vaccineBIOLOGICAL

NicVAX vaccine given 6 times over 6 months

NicVAX conjugate vaccine
PlaceboBIOLOGICAL

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

Placebo
VareniclineDRUG

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)

Also known as: Champix, Chantix
NicVAX conjugate vaccinePlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokes at least 10 cigarettes per day
  • Good general health
  • Negative pregnancy test prior to study entry

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Location

Slotervaart Hospital/ Smoking Cessation Clinic

Amsterdam, North Holland, 1006 BK, Netherlands

Location

Related Publications (3)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

  • 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.

    PMID: 24894625DERIVED

  • 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.

    PMID: 23216646DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Onno van Schayck, Professor Dr

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

NL(2)