Smoking CessationNCT01304810
A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation
An observational study of Smoking Cessation and Nicotine Dependence, run by Nabi Biopharmaceuticals at 12 sites in United States.
Trial summary
The purpose of the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Nicotine Dependence
- 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
- 300 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2011to Aug 2011
- Phase
- Observational
- 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
Study population: Subjects will be invited into this study following their participation in Nabi-4514 or Nabi-4515.
Who may be able to join
- Subjects who agree and sign consent to participate in this follow-up study.
- Subjects randomized and completed month 12 of the Nabi-4514 or Nabi-4515 study.
- Subjects who have received a total of 6 injections in Nabi-4514 or Nabi-4515.
Who cannot join
- Anticipated inability to follow the study protocol through-out the study period.
- Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder compliance or failure to sign informed consent.
- Subjects who intend to receive, or who are receiving an Investigational New Drug/Device during the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
NicVAX Investigator
Boise, Idaho
NicVAX Investigator
Boston, Massachusetts
NicVAX Investigator
College Park, Maryland
NicVAX Investigator
Lexington, Kentucky
NicVAX Investigator
Miami, Florida
NicVAX Investigator
Newport Beach, California
NicVAX Investigator
Norfolk, Virginia
NicVAX Investigator
Portland, Oregon
NicVAX Investigator
Raleigh, North Carolina
NicVAX Investigator
Rochester, New York
NicVAX Investigator
San Diego, California
NicVAX Investigator
Seattle, Washington
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX™ as an Aid to Smoking Cessation
The purpose of the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected.
Read the detailed description
This study will follow subjects that participated in the NicVAX phase III studies for a second year. These predecessor studies, Nabi-4514 (NCT#00836199) and Nabi-4515 (NCT#01102114) evaluate the efficacy and safety of 6 vaccinations of NicVAX or placebo as an aid to smoking cessation. The two phase III studies are one year in duration, and subjects who complete these studies are eligible to enroll in Nabi-4522. As the phase III studies are ongoing, subject assignment to NicVAX or placebo will remain masked. No intervention will be administered in Nabi-4522. Subjects will be followed for immunogenicity (anti-nicotine antibody level)and for safety.
- Conditions
- Smoking Cessation, Nicotine Dependence
- Being tested
- NicVAX vaccine, Placebo
- Keywords
- NicVAX, Smoking cessation
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicVAX vaccineBiological
Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
PlaceboBiological
Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
| Study group | Role | What they receive |
|---|---|---|
| NicVAX | NicVAX vaccine Receives: Biological: NicVAX vaccine | |
| Placebo vaccine | Placebo vaccine Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Levels
Analyze blood samples to determine nicotine antibody levels.
Measured: 24 months after the initial injection
Secondary outcomes (3)
Safety as measured by serious adverse events
Evaluate serious adverse events
Measured: 18 months after the initial injection
Safety as measured by serious adverse events
Evaluate serious adverse events
Measured: 24 months after the initial injection
Antibody Levels
Analyze blood samples to determine nicotine antibody levels
Measured: 18 months after the initial injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304810
- Sponsor's protocol ID
- Nabi-4522
- Status last verified
- May 2012
- First submitted
- 9 Feb 2011
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX™ as an Aid to Smoking Cessation
- ClinicalTrials.gov ID
- NCT01304810
- Acronym / sponsor ID
- Nabi-4522
- Conditions
- Smoking Cessation, Nicotine Dependence
- Keywords
- NicVAX, Smoking cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Feb 2011 (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 the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected.
Detailed description
This study will follow subjects that participated in the NicVAX phase III studies for a second year. These predecessor studies, Nabi-4514 (NCT#00836199) and Nabi-4515 (NCT#01102114) evaluate the efficacy and safety of 6 vaccinations of NicVAX or placebo as an aid to smoking cessation. The two phase III studies are one year in duration, and subjects who complete these studies are eligible to enroll in Nabi-4522. As the phase III studies are ongoing, subject assignment to NicVAX or placebo will remain masked. No intervention will be administered in Nabi-4522. Subjects will be followed for immunogenicity (anti-nicotine antibody level)and for safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NicVAX | – | Biological: NicVAX vaccineNicVAX vaccine |
| Placebo vaccine | – | Biological: PlaceboPlacebo vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be invited into this study following their participation in Nabi-4514 or Nabi-4515.
Key inclusion criteria (3 listed)
- Subjects who agree and sign consent to participate in this follow-up study.
- Subjects randomized and completed month 12 of the Nabi-4514 or Nabi-4515 study.
- Subjects who have received a total of 6 injections in Nabi-4514 or Nabi-4515.
Key exclusion criteria (3 listed)
- Anticipated inability to follow the study protocol through-out the study period.
- Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder compliance or failure to sign informed consent.
- Subjects who intend to receive, or who are receiving an Investigational New Drug/Device during the study.
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 vaccinePrior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522. | Biological | NicVAX |
| PlaceboPrior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522. | Biological | Placebo vaccine |
Primary outcome
Antibody Levels
Time frame: 24 months after the initial injection
Analyze blood samples to determine nicotine antibody levels.
3 secondary outcomes
Safety as measured by serious adverse events
Time frame: 18 months after the initial injection
Safety as measured by serious adverse events
Time frame: 24 months after the initial injection
Antibody Levels
Time frame: 18 months after the initial injection
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 14 May 2012.
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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 Director study director
Nabi Biopharmaceuticals
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Nicotine Dependence, run by Nabi Biopharmaceuticals at 12 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 3 inclusion and 3 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 14 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 12 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Antibody Levels (time frame: 24 months after the initial injection). 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 14 May 2012.