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

This study has been completed.
Sponsor:
Information provided by:
Celtic Pharma Development Services
ClinicalTrials.gov Identifier:
NCT00633321
First received: March 5, 2008
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Smoking
Biological: TA-NIC
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celtic Pharma Development Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of anti-nicotine antibody levels at key study visits [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Quit status at the final follow-up visit (Week 52) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • CO breath test measurements at key study visits [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Serum cotinine levels at key study visits [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Nicotine dependence as measured by Fagerström score, for those subjects who are still smokers [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Urge to smoke (craving) and smoking satisfaction, as measured by QSU-brief and mCEQ, respectively [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Continuous abstinence between Weeks 26 and 52 [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Safety and tolerability of TA-NIC [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 522
Study Start Date: May 2007
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TA-NIC 100 μg
Biological: TA-NIC
TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
Experimental: 2
TA-NIC 250 μg
Biological: TA-NIC
TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
Placebo Comparator: 3 Biological: Placebo
Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633321

Locations
United States, California
Benchmark Research
Sacramento, California, United States, 95816
United States, Louisiana
Benchmark Research
Metairie, Louisiana, United States, 70006
United States, Maryland
Columbia Medical Practice
Columbia, Maryland, United States, 21045
Centennial Medical Group
Elkridge, Maryland, United States, 21075
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
CNS Research Institute, P.C.
Clementon, New Jersey, United States, 08021
United States, Pennsylvania
CRI Worldwide, LLC Kirkbride Center
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Benchmark Research - Fort Worth
Fort Worth, Texas, United States, 76135
Sponsors and Collaborators
Celtic Pharma Development Services
Investigators
Principal Investigator: Krefetz CNS Research Institute, P.C
Principal Investigator: Gruener CRI Worldwide, LLC
Principal Investigator: Coats Benchmark Research
Principal Investigator: Rarick Benchmark Research
Principal Investigator: Seger Benchmark Research - Fort Worth
Principal Investigator: Jeanfreau Benchmark Research
Principal Investigator: Geller Centennial Medical Group
Principal Investigator: Saway Columbia Medical Practice
Principal Investigator: Dale Mayo Clinic
  More Information

Publications:
Fiore MC, Bailey WC, Cohen SJ, et al. Smoking cessation. Clinical Practice Guideline No 18. Rockville, Maryland: US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, April 1996. (AHCPR Publication No 96-0692).
CDC. National Center for Health Statistics: Health, United States, 2004 With Chartbook on Trends in the Health of Americans. Hyattsville, MD: U.S. Department of Health and Human Services, CDC, 2004.
CDC. Cigarette smoking among adults—United States, 2000. MMWR 2002;51(29):642-645.
CDC. The Health Consequences of Smoking: Nicotine Addiction: A Report of the Surgeon General 1988. Rockville, MD: U.S. Department of Health and Human Services, CDC, Center for Health Promotion and Education, Office on Smoking and Health; 1988.
Fiore MC, Bailey WC, Cohen SJ, Dorfman SF, Goldstein MG, Gritz ER, et al. Treating Tobacco Use and Dependence: Quick Reference Guide for Clinicians. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service; 2000.
Westman, E. C., Levin, E. D., & Rose, J. E. Smoking while wearing the nicotine patch: Is smoking satisfying or harmful? Clinical Research. 1992;40, 871A.
Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Confirmatory validation of the Brief Questionnaire of Smoking Urges. Value in Health 2005;8(3):334.

Responsible Party: Patrick O'Connor, MD, PhD - Head of Clinical Developement, Celtic Pharmaceutical Developement
ClinicalTrials.gov Identifier: NCT00633321     History of Changes
Other Study ID Numbers: TA-NIC/04
Study First Received: March 5, 2008
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Celtic Pharma Development Services:
smoking cessation
quit smoking
smoking vaccine
nicotine vaccine
TA-NIC
Aid for smoking cessation in smokers motivated to quit

ClinicalTrials.gov processed this record on August 27, 2014