Smoking CessationPhase 2NCT00218413
Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals
A Phase 2 study testing NicVAX in people with Smoking Cessation and Tobacco Use Cessation, run by Nabi Biopharmaceuticals at 1 site in Netherlands.
Trial summary
Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Tobacco Use Cessation
- What is being tested?
- NicVAX
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2004to Aug 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smoker
- Good general health, including mental health
- Alveolar carbon monoxide level greater than or equal to 10 ppm
Who cannot join
- Prior exposure to NicVAX
- Known allergy to any of the components of NicVAX
- Use of any smoking cessation aide
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers
Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.
Read the detailed description
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.
- Conditions
- Smoking Cessation, Tobacco Use Cessation
- Being tested
- NicVAX
- Keywords
- Vaccine, Immunogenicity, Randomized Controlled Trial, Addiction
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicVAXBiological
Also called 3'-aminomethylnicotine-rEPA conjugate vaccine
100 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
NicVAXBiological
Also called 3'-aminomethylnicotine-rEPA conjugate vaccine
200 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
NicVAXBiological
Also called 3'-aminomethylnicotine-rEPA conjugate vaccine
200 μg, Formulation B, on Days 0, 21, 42m 91 \& 182
NicVAXBiological
Also called 3'-aminomethylnicotine-rEPA conjugate vaccine
300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
NicVAXBiological
Also called 3'-aminomethylnicotine-rEPA conjugate vaccine
400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: NicVAX |
| 2 | Experimental | Not described Receives: Biological: NicVAX |
| 3 | Experimental | Not described Receives: Biological: NicVAX |
| 4 | Experimental | Not described Receives: Biological: NicVAX |
| 5 | Experimental | Not described Receives: Biological: NicVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-nicotine Antibody concentrations
Measured: 19 time points from Day 0 to 365
Secondary outcomes (4)
Smoking cessation
Measured: periods of 2 weeks, 4 weeks, or 12 weeks duration
Fagerstrom Test for Nicotine Dependence
Measured: 7 time points from Day 0 to 365
Safety: vaccine reactogenicity
Measured: 7 days after each dose
Safety: adverse events
Measured: Day 0-365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Gary Horwith, Principal investigator, Nabi BiopharmaceuticalsArjen De Vos, MD, PhD, Principal investigator, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218413
- Sponsor's protocol ID
- NIDA-17894-2
- Other IDs
- Nabi-4505, R01-17894-2, DPMC
- Status last verified
- Nov 2008
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers
- ClinicalTrials.gov ID
- NCT00218413
- Acronym / sponsor ID
- NIDA-17894-2
- Conditions
- Smoking Cessation, Tobacco Use Cessation
- Keywords
- Vaccine, Immunogenicity, Randomized Controlled Trial, Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 22 Sep 2005 (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.
Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.
Detailed description
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: NicVAX |
| 2 | Experimental | Biological: NicVAX |
| 3 | Experimental | Biological: NicVAX |
| 4 | Experimental | Biological: NicVAX |
| 5 | Experimental | Biological: NicVAX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current smoker
- Good general health, including mental health
- Alveolar carbon monoxide level greater than or equal to 10 ppm
Key exclusion criteria (4 listed)
- Prior exposure to NicVAX
- Known allergy to any of the components of NicVAX
- Use of any smoking cessation aide
- Pregnant or breastfeeding
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 |
|---|---|---|
| NicVAXAlso: 3'-aminomethylnicotine-rEPA conjugate vaccine100 μg, Formulation A, on Days 0, 21, 42, 91 \& 182 | Biological | 1 |
| NicVAXAlso: 3'-aminomethylnicotine-rEPA conjugate vaccine200 μg, Formulation A, on Days 0, 21, 42, 91 \& 182 | Biological | 2 |
| NicVAXAlso: 3'-aminomethylnicotine-rEPA conjugate vaccine200 μg, Formulation B, on Days 0, 21, 42m 91 \& 182 | Biological | 3 |
| NicVAXAlso: 3'-aminomethylnicotine-rEPA conjugate vaccine300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182 | Biological | 4 |
| NicVAXAlso: 3'-aminomethylnicotine-rEPA conjugate vaccine400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182 | Biological | 5 |
Primary outcome
Anti-nicotine Antibody concentrations
Time frame: 19 time points from Day 0 to 365
4 secondary outcomes
Smoking cessation
Time frame: periods of 2 weeks, 4 weeks, or 12 weeks duration
Fagerstrom Test for Nicotine Dependence
Time frame: 7 time points from Day 0 to 365
Safety: vaccine reactogenicity
Time frame: 7 days after each dose
Safety: adverse events
Time frame: Day 0-365
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 12 Jan 2017.
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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.
Gary Horwith principal investigator
Nabi Biopharmaceuticals
Arjen De Vos, MD, PhD principal investigator
Nabi Biopharmaceuticals
1 site 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 in people with Smoking Cessation and Tobacco Use Cessation, run by Nabi Biopharmaceuticals at 1 site 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 4 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Anti-nicotine Antibody concentrations (time frame: 19 time points from Day 0 to 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2017.