SmokingPhase 3NCT01375933
A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
A Phase 3 study testing NicVAX Vaccine in people with Smoking, run by Nabi Biopharmaceuticals at 6 sites in United States.
Trial summary
The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- NicVAX Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2011to Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.
Who cannot join
- Prior exposure to NicVAX or any other nicotine vaccine.
- History of clinically significant allergic reactions.
- Use of systemic steroids.
- Cancer or cancer treatment within 5 years.
- HIV infection.
- History of drug or alcohol abuse or dependence.
Show all 10Show fewer
- Required treatment for depression within the past 12 months.
- Body mass index ≥ 30 [calculated as weight (kg)/height2 (m)].
- Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
- Inability to fulfill all visits for approximately 30 weeks.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NicVAX Investigator
Huntsville, Alabama, 35802
NicVAX Investigator
Melbourne, Florida, 32935
NicVAX Investigator
Peoria, Illinois, 61602
NicVAX Investigator
Rockville, Maryland, 20850
NicVAX Investigator
San Diego, California, 92018
NicVAX Investigator
South Bend, Indiana, 46601
About this study
Official title: A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers
The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.
- Conditions
- Smoking
- Being tested
- NicVAX Vaccine
- Keywords
- Smoking, NicVAX, Smoking vaccine
- Medical subject headings
- Smoking
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
| Study group | Role | What they receive |
|---|---|---|
| NicVAX - Phase 3 Lot | Active comparator | NicVAX - Phase 3 Lot Receives: Biological: NicVAX Vaccine |
| NicVAX - Commercial Lot | Active comparator | NicVAX - Commercial Lot Receives: Biological: NicVAX Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
To compare imunogenicity of two lots by serum antibody concentration
Measured: At Week 14
Secondary outcomes (1)
Safety
Assess safety by adverse events reported
Measured: Through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabi Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Nabi Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375933
- Sponsor's protocol ID
- Nabi-4516
- Status last verified
- May 2012
- First submitted
- 15 Jun 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, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers
- ClinicalTrials.gov ID
- NCT01375933
- Acronym / sponsor ID
- Nabi-4516
- Conditions
- Smoking
- Keywords
- Smoking, NicVAX, Smoking vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Jun 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 this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.
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 - Phase 3 Lot | Active comparator | Biological: NicVAX VaccineNicVAX - Phase 3 Lot |
| NicVAX - Commercial Lot | Active comparator | Biological: NicVAX VaccineNicVAX - Commercial Lot |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.
Key exclusion criteria (10 listed)
- Prior exposure to NicVAX or any other nicotine vaccine.
- History of clinically significant allergic reactions.
- Use of systemic steroids.
- Cancer or cancer treatment within 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 - Commercial Lot, NicVAX - Phase 3 Lot |
Primary outcome
Immunogenicity
Time frame: At Week 14
To compare imunogenicity of two lots by serum antibody concentration
1 secondary outcome
Safety
Time frame: Through Week 16
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 Monitor study director
Nabi Biopharmaceuticals
6 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, run by Nabi Biopharmaceuticals at 6 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 1 inclusion and 10 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 6 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.
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?
Immunogenicity (time frame: At Week 14). 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.