Smoking BehaviorPhase 2NCT00995033
Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
A Phase 2 study testing NicVAX vaccine and Varenicline in people with Smoking Behavior and Smoking Lapse Behavior, run by Maastricht University Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Behavior, Smoking Lapse Behavior, Smoking Relapse Behavior
- What is being tested?
- NicVAX vaccine and Varenicline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 558 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2009to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokes at least 10 cigarettes per day
- Good general health
- Negative pregnancy test prior to study entry
Who cannot join
- 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
Show all 9Show fewer
- Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease
- Previous intolerance to varenicline
- Inability to fulfill all visits for approximately 54 weeks
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Slotervaart Hospital/ Smoking Cessation Clinic
Amsterdam, North Holland, 1006 BK
Maastricht University Medical Center
Maastricht, Limburg, 6200 MD
About this study
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
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.
- Being tested
- NicVAX vaccine, Placebo, Varenicline
- Keywords
- Smoking cessation, Smoking lapse behavior, Smoking Relapse behavior, Varenicline, Nicotine conjugate vaccine, Medication effect on smoking lapse behavior
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicVAX vaccineBiological
NicVAX vaccine given 6 times over 6 months
PlaceboBiological
Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months
VareniclineDrug
Also called Champix, Chantix
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 group | Role | What they receive |
|---|---|---|
| NicVAX conjugate vaccine | Experimental | Not described Receives: Biological: NicVAX vaccine; Drug: Varenicline |
| Placebo | Placebo comparator | Biological Receives: Biological: Placebo; Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term abstinence
Measured: one year
Secondary outcomes (4)
Safety, immunogenicity
Measured: continuous assessment throughout the one year study duration
Abstinence
Measured: continuous assessment throughout the one year study duration
Lapse and relapse rate
Measured: continuous assessment throughout the one year study duration
Withdrawal symptoms
Measured: continuous assessment throughout the one year study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking BehaviorStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Nabi Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Onno van Schayck, Professor Dr, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995033
- Sponsor's protocol ID
- MEC 08-5-066
- Other IDs
- ZonMw 40-00812-98-07-004, ZonMw 61200014, Nabi-4508
- Status last verified
- Feb 2013
- First submitted
- 6 Oct 2009
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37142273Hoogsteder 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.
PubMed 24894625Hoogsteder 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.
PubMed 23216646
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00995033
- Acronym / sponsor ID
- MEC 08-5-066
- Keywords
- Smoking cessation, Smoking lapse behavior, Smoking Relapse behavior, Varenicline, Nicotine conjugate vaccine, Medication effect on smoking lapse behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Nabi Biopharmaceuticals
- Study start
- Oct 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NicVAX conjugate vaccine | Experimental | Biological: NicVAX vaccine, Drug: Varenicline |
| Placebo | Placebo comparator | Biological: Placebo, Drug: VareniclineBiological |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Smokes at least 10 cigarettes per day
- Good general health
- Negative pregnancy test prior to study entry
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicVAX vaccineNicVAX vaccine given 6 times over 6 months | Biological | NicVAX conjugate vaccine |
| PlaceboPhosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months | Biological | Placebo |
| VareniclineAlso: Champix, ChantixDays 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) | Drug | NicVAX conjugate vaccine, Placebo |
Primary outcome
Long term abstinence
Time frame: one year
4 secondary outcomes
Safety, immunogenicity
Time frame: continuous assessment throughout the one year study duration
Abstinence
Time frame: continuous assessment throughout the one year study duration
Lapse and relapse rate
Time frame: continuous assessment throughout the one year study duration
Withdrawal symptoms
Time frame: continuous assessment throughout the one year study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Derived from this study: PubMed 37142273Livingstone-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.
- Derived from this study: PubMed 24894625Hoogsteder 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.
- Derived from this study: PubMed 23216646Hoogsteder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onno van Schayck, Professor Dr principal investigator
Maastricht University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NicVAX vaccine and Varenicline in people with Smoking Behavior and Smoking Lapse Behavior, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term abstinence (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995033, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.