Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
NCT ID: NCT00995033
Last Updated: 2013-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
558 participants
INTERVENTIONAL
2009-10-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NicVAX conjugate vaccine
NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
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)
Placebo
Biological
Placebo
Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months
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)
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good general health
* Negative pregnancy test prior to study entry
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Nabi Biopharmaceuticals
INDUSTRY
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Onno van Schayck, Professor Dr
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Slotervaart Hospital/ Smoking Cessation Clinic
Amsterdam, North Holland, Netherlands
Countries
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References
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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.
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.
Other Identifiers
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ZonMw 40-00812-98-07-004
Identifier Type: -
Identifier Source: secondary_id
ZonMw 61200014
Identifier Type: -
Identifier Source: secondary_id
Nabi-4508
Identifier Type: -
Identifier Source: secondary_id
MEC 08-5-066
Identifier Type: -
Identifier Source: org_study_id
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