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Smoking CessationPhase 2NCT00318383

Efficacy of NicVAX in Smokers Who Want to Quit Smoking

A Phase 2 study testing NicVAX conjugate vaccine in people with Smoking Cessation, run by National Institute on Drug Abuse (NIDA) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
NicVAX conjugate vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
313 participants
Where
9 sitesUnited States
Study dates
May 2006to Dec 2007
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

  • Smokes at least 15 cigarettes per day
  • Wants to quit smoking
  • Good general health
  • Negative pregnancy test prior to study entry
  • Carbon monoxide level greater than 10 ppm

Who cannot join

  • Prior exposure to NicVAX or any other nicotine vaccine
  • Known allergic reaction to alum or any of the components of the vaccine
  • Use of steroids, immunosuppressive agents or other medication that might interfere with an immune response

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Tobacco Research Center, Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Department of Public & Community Health

    College Park, Maryland, 20742

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53711

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: A Phase 2, Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Assess Efficacy of 3'-Aminomethylnicotine-P.Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Smokers Who Want to Quit Smoking

The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addition, two different formulations and dosing schedules will be studied, to select the dose and dosing schedule which generates the highest level of anti-nicotine antibodies. The primary study period is 12 months, which was extended by amendment to include up to 2 years of observations.

Read the detailed description

Cigarette smoking is responsible for over 400,000 (1 out of every 5) deaths in the United States each year. Most smokers are aware of the health consequences and want to quit, but have difficulty doing so. Only 3-5% of smokers who quit on their own are successful. Since the vast majority of those who attempt to quit will fail, the need for better approaches to smoking cessation is clear and urgent. A safe and effective means of blocking the effects of nicotine would be of considerable interest as a potential treatment for tobacco use. Vaccination to produce nicotine-specific antibodies may be viewed as an alternative method of blocking nicotine effects. Nicotine is a small molecule that does not elicit an immune response in animals of humans. In order for the immune system to respond to this hapten, nicotine can be combined or bound to a larger molecule in a unique manner so that an immune response is mounted against nicotine. Nabi Biopharmaceuticals has developed a conjugate vaccine (NicVAX) that consists of 3'-aminomethylnicotine bound to Pseudomonas aeruginosa exoprotein A, an exotoxin that has been made non-toxic by an amino acid deletion. Subjects will be randomized to one of four treatment groups.

Within each treatment group, 75 subjects will be randomized in a 2:1 ratio (NicVAX:Placebo), yielding a total of 50 active and 25 placebo subjects for each treatment group. There will be 12 subjects enrolled in a fifth open label arm to evaluate immunogenicity. A quit date will be set at the end of week 7 or at the end of week 5, depending on the dosing schedule. Continuous abstinence will be measured between the end of week 18 and the end of week 26.

Being tested
NicVAX conjugate vaccine, Placebo
Keywords
Vaccine, Immunogenicity, Randomized Controlled Trial
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NicVAX conjugate vaccineBiological

    Also called 3'-aminomethylnicotine-rEPA conjugate vaccine

    200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel

  • PlaceboBiological

    Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months

Study groups in NCT00318383
Study groupRoleWhat they receive
1Experimental200 mcg NicVAX in each of 4 doses
Receives: Biological: NicVAX conjugate vaccine
2Experimental200 mcg NicVAX in each of 5 doses
Receives: Biological: NicVAX conjugate vaccine
3Experimental400 mcg NicVAX in each of 4 doses
Receives: Biological: NicVAX conjugate vaccine
4Experimental400 mcg NicVAX in each of 5 doses
Receives: Biological: NicVAX conjugate vaccine
5Placebo comparatorPlacebo in 4 or 5 doses
Receives: Biological: Placebo
6Experimental200 mcg NicVAX formulation 2 in each of 5 doses
Receives: Biological: NicVAX conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous smoking abstinence

    Measured: 8 week interval (Weeks 19 to 26, inclusive, following the first vaccination)

Secondary outcomes (11)

  1. Point prevalence abstinence

    Measured: at 12 months, and other time points; extended up to 24 months

  2. Duration of smoking abstinence

    Measured: at 6 and 12 months

  3. Safety

    Measured: 0-12 months, and extended up to 24 months

  4. Numbers of cigarettes per day

    Measured: Target quit day to 12 months

  5. Cumulative number of cigarettes smoked

    Measured: during weeks 18-26

  6. Exhaled CO

    Measured: at clinic visits

  7. Urine cotinine

    Measured: at clinic visits

  8. Modified Minnesota Nicotine Withdrawal Questionnaire

    Measured: weekly for 6 months, daily for 14 days after quit attempt

  9. Cigarette Evaluation Questionnaire (a.k.a. Nabi Questionnaire)

    Measured: weekly for 6 motnhs

  10. Fagerstrom Test for Nicotine Dependence

    Measured: baseline, weeks 26 and 52

  11. serum anti-nicotine antibody concentrations by Elisa

    Measured: periodic from baseline to month 12, extended to month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionSep 2007
  4. Study completionDec 2007

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00318383
Sponsor's protocol ID
Nabi - 4512
Other IDs
1R01DA017894-01A1
Status last verified
Nov 2008
First submitted
24 Apr 2006
Last updated
12 Jan 2017
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

  • Hatsukami 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NicVAX conjugate vaccine in people with Smoking Cessation, run by National Institute on Drug Abuse (NIDA) at 9 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 5 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 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 9 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 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?

Continuous smoking abstinence (time frame: 8 week interval (Weeks 19 to 26, inclusive, following the first vaccination)). 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 NCT00318383, 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 12 Jan 2017.

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