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

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.