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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

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

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

Outcome Time Frame:

Week 26

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

CNS Research Institute, P.C


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

February 2009

Related Keywords:

  • Smoking
  • smoking cessation
  • quit smoking
  • smoking vaccine
  • nicotine vaccine
  • TA-NIC
  • Aid for smoking cessation in smokers motivated to quit
  • Smoking



Mayo ClinicRochester, Minnesota  55905
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Benchmark ResearchSacramento, California  95816
Benchmark ResearchMetairie, Louisiana  70006
Columbia Medical PracticeColumbia, Maryland  21045
CNS Research Institute, P.C.Clementon, New Jersey  08021
CRI Worldwide, LLC Kirkbride CenterPhiladelphia, Pennsylvania  19139
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Benchmark Research - Fort WorthFort Worth, Texas  76135