Smoking CessationPhase 3NCT00836199
NicVAX/Placebo as an Aid for Smoking Cessation
A Phase 3 study testing NicVAX vaccine in people with Smoking Cessation and Smoking, run by Nabi Biopharmaceuticals at 22 sites in United States.
Trial summary
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Smoking, Tobacco Cessation
- What is being tested?
- NicVAX vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 22 sitesUnited States
- Study dates
- Oct 2009to Jul 2011
- Phase
- Phase 3
- 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
- Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
- Smokers who are in good general health.
Who cannot join
- Prior exposure to NicVAX or any other nicotine vaccine.
- Use of systemic steroids.
- Cancer or cancer treatment in 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.
- Inability to fulfill all visits for approximately 52 weeks.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
NicVAX Investigator
Baltimore, Maryland
NicVAX Investigator
Boise, Idaho
NicVAX Investigator
Boston, Massachusetts
NicVAX Investigator
College Park, Maryland
NicVAX Investigator
Denver, Colorado
NicVAX Investigator
Draper, Utah
NicVAX Investigator
Farmington, Connecticut
NicVAX Investigator
Lexington, Kentucky
NicVAX Investigator
Los Angeles, California
NicVAX Investigator
Madison, Wisconsin
NicVAX Investigator
Miami, Florida
NicVAX Investigator
Minneapolis, Minnesota
NicVAX Investigator
Newport Beach, California
NicVAX Investigator
Norfolk, Virginia
NicVAX Investigator
Omaha, Nebraska
NicVAX Investigator
Portland, Oregon
NicVAX Investigator
Raleigh, North Carolina
NicVAX Investigator
Rochester, New York
NicVAX Investigator
San Diego, California
NicVAX Investigator
Seattle, Washington
NicVAX Investigator
St. Petersburg, Florida
NicVAX Investigator
Tucson, Arizona
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
- Conditions
- Smoking Cessation, Smoking, Tobacco Cessation
- Being tested
- NicVAX vaccine, Placebo vaccine
- Keywords
- smoking cessation, NicVAX, smoking vaccine, smoking abstinence, smoking, tobacco cessation
- Medical subject headings
- Smoking Cessation, Smoking, Tobacco Use 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
Placebo vaccineBiological
Placebo vaccine given 6 times over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo vaccine | Placebo comparator | Not described Receives: Biological: Placebo vaccine |
| NicVAX vaccine | Experimental | Not described Receives: Biological: NicVAX vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Measured: one year
Secondary outcomes (3)
Evaluate abstinence rates at multiple intervals
Measured: multiple time points
Evaluate safety and immunogenicity
Measured: mulitple time points
Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.
Measured: multiple time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836199
- Sponsor's protocol ID
- Nabi-4514
- Other IDs
- NIH grant # 1 RC2 DA028837-01
- Status last verified
- May 2012
- First submitted
- 3 Feb 2009
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343.
PubMed 22229310
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
- ClinicalTrials.gov ID
- NCT00836199
- Acronym / sponsor ID
- Nabi-4514
- Conditions
- Smoking Cessation, Smoking, Tobacco Cessation
- Keywords
- smoking cessation, NicVAX, smoking vaccine, smoking abstinence, smoking, tobacco cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Feb 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 NicVAX as an aid to smoking cessation for long term abstinence.
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 |
|---|---|---|
| Placebo vaccine | Placebo comparator | Biological: Placebo vaccine |
| NicVAX vaccine | Experimental | Biological: NicVAX vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
- Smokers who are in good general health.
Key exclusion criteria (7 listed)
- Prior exposure to NicVAX or any other nicotine vaccine.
- Use of systemic steroids.
- Cancer or cancer treatment in last 5 years.
- HIV infection.
- History of drug or alcohol abuse or dependence within 12 months.
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 vaccine |
| Placebo vaccinePlacebo vaccine given 6 times over 6 months | Biological | Placebo vaccine |
Primary outcome
Evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Time frame: one year
3 secondary outcomes
Evaluate abstinence rates at multiple intervals
Time frame: multiple time points
Evaluate safety and immunogenicity
Time frame: mulitple time points
Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.
Time frame: multiple time points
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 9 May 2012.
- Derived from this study: PubMed 22229310Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343.
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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.
Medical Monitor study director
Nabi Biopharmaceuticals
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NicVAX vaccine in people with Smoking Cessation and Smoking, run by Nabi Biopharmaceuticals at 22 sites in United States.
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 2 inclusion and 7 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 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluate NicVAX as an aid to smoking cessation for 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 NCT00836199, which also lists 1 linked publication.
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 9 May 2012.