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SmokingPhase 2NCT00633321

Study of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

A Phase 2 study testing TA-NIC in people with Smoking, run by Celtic Pharma Development Services 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

Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking
What is being tested?
TA-NIC
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
522 participants
Where
9 sitesUnited States
Study dates
May 2007to Feb 2009
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years
  • Female subjects must be either of non child bearing potential (i.e., either surgically sterilized or post menopausal) or must be using adequate contraception, have a negative pregnancy test and must agree to continue to use such precautions for 3 months after the last immunization. Acceptable contraceptive methods are oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence or partner vasectomy are not acceptable methods.
  • A "smoker" who has smoked on a regular basis for a least a year and is currently smoking at least 10 cigarettes per day
  • Is motivated to quit smoking in the next 12 weeks
  • Agrees to avoid smoking cessation pharmacotherapies, and any other methods of smoking cessation, other than those provided as part of this protocol
  • Has good general health as determined by medical history, general clinical examination, vital signs (systolic blood pressure ≤140 mm Hg, diastolic blood pressure ≤90 mm Hg, heart rate ≤100 beats per minute, and body temperature of 36.1°-37.8° C), and clinical laboratory test results; and has a World Health Organization (WHO) performance status of 0 or 1 (see Appendix A for WHO performance status scale)
  • Has provided written informed consent.

Who cannot join

  • Have known immunodeficiency, or tested positive for human immunodeficiency virus (HIV) or hepatitis B at screening.
  • Are taking medication known to have significant immunosuppressive effects such as systemic glucocorticoids (topical and inhaled formulations are permitted)
  • Are intending to use other forms of smoking cessation pharmacotherapies or other methods of smoking cessation during the period of the study, other than those provided as part of this protocol; or who are receiving smoking cessation products (e.g., bupropion, clonidine, nortriptyline) for indications other than smoking cessation during the period of study
  • History of sensitivity to aluminum hydroxide gel
  • History of severe adverse reaction to cholera vaccine
  • Known current user of drugs of abuse, or with a recent history (within the past 6 months) of use of drugs of abuse
Show all 13Show fewer
  • Recent (within the past 6 months) history of alcohol abuse
  • Current non-cigarette tobacco use
  • Previous vaccination with TA-NIC
  • Participation in another clinical study within 30 days before study entry
  • Female subjects with a positive pregnancy test; lactating mothers; women of child-bearing potential who do not agree to continue adequate contraception (i.e., oral or parenteral hormonal contraceptives, intrauterine device, barrier, and/or spermicide) and pregnancy tests from start of study through 3 months after the last immunization; or women who are planning to become pregnant during the period of the study
  • Clinical laboratory value outside the normal range of the central laboratory (see Appendix G), unless the value has been justified by the Investigator in writing
  • Any other factor that in the opinion of the Investigator would make the subject unsuitable for the study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Benchmark Research

    Austin, Texas, 78705

  • CNS Research Institute, P.C.

    Clementon, New Jersey, 08021

  • Columbia Medical Practice

    Columbia, Maryland, 21045

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Benchmark Research - Fort Worth

    Fort Worth, Texas, 76135

  • Benchmark Research

    Metairie, Louisiana, 70006

  • CRI Worldwide, LLC Kirkbride Center

    Philadelphia, Pennsylvania, 19139

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Benchmark Research

    Sacramento, California, 95816

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study of 100 or 250 μg of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year.

This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.

Read the detailed description

This is a multicenter, double-blind, randomized, placebocontrolled, 3-arm, Phase 2 study evaluating the efficacy and safety of TA-NIC as an aid for smoking cessation in smokers motivated to quit within 12 weeks. At the start of the study, each subject will set a Target Quit Date, which must be within 12 weeks after first injection. Each subject will receive 7 injections (vaccinations) from Weeks 0 to 16. Subjects will be encouraged to follow a phased reduction in cigarette consumption leading up to the Target Quit Date. All vaccinated subjects will be offered a counseling session at each clinic visit and will be contacted by telephone at Weeks 1, 3, 5, 7, 9, 14, 18, and 21 to provide up to 10 minutes of support and counseling for their smoking cessation. Smoking cessation will be measured during a 4-week assessment period from Week 22 to Week 26. Smoking cessation will be defined as complete abstinence during this 4-week period. Subject follow-up will continue to Week 52.

Conditions
Smoking
Being tested
TA-NIC, Placebo
Keywords
smoking cessation, quit smoking, smoking vaccine, nicotine vaccine, TA-NIC, Aid for smoking cessation in smokers motivated to quit
Medical subject headings
Smoking, Smoking Cessation

What participants receive

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

  • TA-NICBiological

    TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

  • PlaceboBiological

    Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

Study groups in NCT00633321
Study groupRoleWhat they receive
1ExperimentalTA-NIC 100 μg
Receives: Biological: TA-NIC
2ExperimentalTA-NIC 250 μg
Receives: Biological: TA-NIC
3Placebo comparatorNot described
Receives: Biological: Placebo

What is being measured

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

  1. 4-week assessment period quit rate at Week 26 measured by self-reported abstinence in the 4 weeks immediately prior to the 26 week visit and supported by CO breath test data

    Measured: Week 26

Secondary outcomes (8)

  1. Measures of anti-nicotine antibody levels at key study visits

    Measured: Prospective

  2. Quit status at the final follow-up visit (Week 52)

    Measured: Week 52

  3. CO breath test measurements at key study visits

    Measured: Prospective

  4. Serum cotinine levels at key study visits

    Measured: Prospective

  5. Nicotine dependence as measured by Fagerström score, for those subjects who are still smokers

    Measured: Prospective

  6. Urge to smoke (craving) and smoking satisfaction, as measured by QSU-brief and mCEQ, respectively

    Measured: Prospective

  7. Continuous abstinence between Weeks 26 and 52

    Measured: Prospective

  8. Safety and tolerability of TA-NIC

    Measured: Prospective

Timeline

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

  1. First posted12 Mar 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2008
  4. Study completionFeb 2009

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
522 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00633321
Sponsor's protocol ID
TA-NIC/04
Status last verified
Jun 2011
First submitted
5 Mar 2008
Last updated
8 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Doll R, Hill AB. The mortality of doctors in relation to their smoking habits: a preliminary report. 1954. BMJ. 2004 Jun 26;328(7455):1529-33; discussion 1533. doi: 10.1136/bmj.328.7455.1529. No abstract available.

    PubMed 15217868

  • Centers for Disease Control and Prevention (CDC). Annual smoking-attributable mortality, years of potential life lost, and economic costs--United States, 1995-1999. MMWR Morb Mortal Wkly Rep. 2002 Apr 12;51(14):300-3.

    PubMed 12002168

  • Centers for Disease Control and Prevention (CDC). Annual smoking-attributable mortality, years of potential life lost, and productivity losses--United States, 1997-2001. MMWR Morb Mortal Wkly Rep. 2005 Jul 1;54(25):625-8.

    PubMed 15988406

  • Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2004;(3):CD000146. doi: 10.1002/14651858.CD000146.pub2.

    PubMed 15266423

  • Hall SM, Humfleet GL, Reus VI, Munoz RF, Hartz DT, Maude-Griffin R. Psychological intervention and antidepressant treatment in smoking cessation. Arch Gen Psychiatry. 2002 Oct;59(10):930-6. doi: 10.1001/archpsyc.59.10.930.

    PubMed 12365880

  • Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD000031. doi: 10.1002/14651858.CD000031.pub3.

    PubMed 17253443

  • Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR, Smith SS, Muramoto ML, Daughton DM, Doan K, Fiore MC, Baker TB. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med. 1999 Mar 4;340(9):685-91. doi: 10.1056/NEJM199903043400903.

    PubMed 10053177

  • Silagy C, Mant D, Fowler G, Lodge M. Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. Lancet. 1994 Jan 15;343(8890):139-42. doi: 10.1016/s0140-6736(94)90933-4.

    PubMed 7904003

  • West RJ, Russell MA. Cardiovascular and subjective effects of smoking before and after 24 h of abstinence from cigarettes. Psychopharmacology (Berl). 1987;92(1):118-21. doi: 10.1007/BF00215491.

    PubMed 3110822

  • Pentel PR, Malin DH, Ennifar S, Hieda Y, Keyler DE, Lake JR, Milstein JR, Basham LE, Coy RT, Moon JW, Naso R, Fattom A. A nicotine conjugate vaccine reduces nicotine distribution to brain and attenuates its behavioral and cardiovascular effects in rats. Pharmacol Biochem Behav. 2000 Jan 1;65(1):191-8. doi: 10.1016/s0091-3057(99)00206-3.

    PubMed 10638653

  • Malin DH, Lake JR, Lin A, Saldana M, Balch L, Irvin ML, Chandrasekara H, Alvarado CL, Hieda Y, Keyler DE, Pentel PR, Ennifar S, Basham LE, Naso R, Fattom A. Passive immunization against nicotine prevents nicotine alleviation of nicotine abstinence syndrome. Pharmacol Biochem Behav. 2001 Jan;68(1):87-92. doi: 10.1016/s0091-3057(00)00436-6.

    PubMed 11274712

  • Hieda Y, Keyler DE, VanDeVoort JT, Niedbala RS, Raphael DE, Ross CA, Pentel PR. Immunization of rats reduces nicotine distribution to brain. Psychopharmacology (Berl). 1999 Apr;143(2):150-7. doi: 10.1007/s002130050930.

    PubMed 10326777

  • Hieda Y, Keyler DE, Ennifar S, Fattom A, Pentel PR. Vaccination against nicotine during continued nicotine administration in rats: immunogenicity of the vaccine and effects on nicotine distribution to brain. Int J Immunopharmacol. 2000 Oct;22(10):809-19. doi: 10.1016/s0192-0561(00)00042-4.

    PubMed 10963853

  • Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549.

    PubMed 2668531

  • Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

    PubMed 1932883

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TA-NIC in people with Smoking, run by Celtic Pharma Development Services 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 7 inclusion and 13 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 8 Jun 2011. 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?

4-week assessment period quit rate at Week 26 measured by self-reported abstinence in the 4 weeks immediately prior to the 26 week visit and supported by CO breath test data (time frame: Week 26). 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 NCT00633321, which also lists 35 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 8 Jun 2011.

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