SmokingPhase 1/2NCT00598325
Antibody and Safety Study of 6 Doses of NicVAX in Smokers
A Phase 1/2 study testing 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) in people with Smoking, run by Nabi Biopharmaceuticals at 1 site in United States.
Trial summary
Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking
- What is being tested?
- 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Oct 2010
- Phase
- Phase 1/2
- 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
- Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
- Written informed consent
- Negative urine pregnancy test, and willing to use birth control during the study, if applicable
Who cannot join
- Prior exposure to nicotine vaccine
- Clinically significant allergic reactions, especially to components of the vaccine
- Serious or unstable clinical disease within the past 6 months
- Use of any smoking cessation therapy within 30 days preceding 1st dose
- Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
- Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
- Use of another IND drug or device within 30 days preceding 1st dose
- Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers
Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.
- Conditions
- Smoking
- Being tested
- 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
- Keywords
- Nicotine, Vaccine, Immunogenicity, Tobacco, Habits
- Medical subject headings
- Smoking, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)Biological
Also called NicVAX
1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
| Study group | Role | What they receive |
|---|---|---|
| NicVAX | Experimental | Not described Receives: Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) |
| NicVAX Lot 2 | Experimental | 2nd cohort receives a different lot of vaccine from the 1st cohort Receives: Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-nicotine antibody concentration
Measured: 12 time points between screening and week 20
Secondary outcomes (2)
Vaccine reactogenicity
Measured: for 7 days after each dose
Adverse events
Measured: for 30 weeks after 1st dose (4 wk after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt Hohenboken, MD, PhD, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598325
- Sponsor's protocol ID
- Nabi-4513
- Status last verified
- May 2012
- First submitted
- 9 Jan 2008
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
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 22229310Hatsukami DK, Jorenby DE, Gonzales D, Rigotti NA, Glover ED, Oncken CA, Tashkin DP, Reus VI, Akhavain RC, Fahim RE, Kessler PD, Niknian M, Kalnik MW, Rennard SI. Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clin Pharmacol Ther. 2011 Mar;89(3):392-9. doi: 10.1038/clpt.2010.317. Epub 2011 Jan 26.
PubMed 21270788
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
- Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers
- ClinicalTrials.gov ID
- NCT00598325
- Acronym / sponsor ID
- Nabi-4513
- Conditions
- Smoking
- Keywords
- Nicotine, Vaccine, Immunogenicity, Tobacco, Habits
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Jan 2008 (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.
Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NicVAX | Experimental | Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) |
| NicVAX Lot 2 | Experimental | Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)2nd cohort receives a different lot of vaccine from the 1st cohort |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
- Written informed consent
- Negative urine pregnancy test, and willing to use birth control during the study, if applicable
Key exclusion criteria (8 listed)
- Prior exposure to nicotine vaccine
- Clinically significant allergic reactions, especially to components of the vaccine
- Serious or unstable clinical disease within the past 6 months
- Use of any smoking cessation therapy within 30 days preceding 1st dose
- Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
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 |
|---|---|---|
| 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)Also: NicVAX1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16) | Biological | NicVAX, NicVAX Lot 2 |
Primary outcome
Anti-nicotine antibody concentration
Time frame: 12 time points between screening and week 20
2 secondary outcomes
Vaccine reactogenicity
Time frame: for 7 days after each dose
Adverse events
Time frame: for 30 weeks after 1st dose (4 wk after last dose)
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.
- Derived from this study: PubMed 21270788Hatsukami DK, Jorenby DE, Gonzales D, Rigotti NA, Glover ED, Oncken CA, Tashkin DP, Reus VI, Akhavain RC, Fahim RE, Kessler PD, Niknian M, Kalnik MW, Rennard SI. Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clin Pharmacol Ther. 2011 Mar;89(3):392-9. doi: 10.1038/clpt.2010.317. Epub 2011 Jan 26.
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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.
Matt Hohenboken, MD, PhD study director
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 1/2 study testing 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) in people with Smoking, run by Nabi Biopharmaceuticals at 1 site 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 8 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 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 concentration (time frame: 12 time points between screening and week 20). 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 NCT00598325, which also lists 2 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 9 May 2012.