Efficacy and Safety of NicVAX® Co-administered With Varen... | NCT00995033

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

NCT00995033

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 20, 2013Estimated

Enrollment

558Actual

Phase

Phase 2

Conditions

Smoking Behavior
Smoking Lapse Behavior
Smoking Relapse Behavior

Interventions

NicVAX vaccine
Placebo
Varenicline

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 6, 2009

First Submission Date that Met QC Criteria

Oct 12, 2009

First Posted Date

Oct 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2013

Last Update Posted Date

Feb 20, 2013Estimated

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER
Nabi Biopharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

558Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NicVAX conjugate vaccine	Experimental		Biological: NicVAX vaccine Drug: Varenicline
Placebo	Placebo Comparator	Biological	Biological: Placebo Drug: Varenicline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NicVAX vaccine	Biological	NicVAX vaccine given 6 times over 6 months	NicVAX conjugate vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term abstinence		one year

Secondary Outcomes

Measure	Description	Time Frame
Safety, immunogenicity		continuous assessment throughout the one year study duration
Abstinence		continuous assessment throughout the one year study duration

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Onno van Schayck, Professor Dr	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center		Maastricht	Limburg	6200 MD	Netherlands
Slotervaart Hospital/ Smoking Cessation Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37142273	Derived	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.
24894625	Derived	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.

ID	Type	Description	Link
ZonMw 40-00812-98-07-004
ZonMw 61200014
Nabi-4508

ID	Term
D001519	Behavior
D015438	Health Behavior

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds