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

Completed · Phase 2 · Has a placebo group

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT00633321

Run by

Celtic Pharma Development Services

People needed

522

Starts

2007-05-01

Expected to finish

2009-02-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Benchmark Research — Sacramento, California, United States
• Benchmark Research — Metairie, Louisiana, United States
• Columbia Medical Practice — Columbia, Maryland, United States
• Centennial Medical Group — Elkridge, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• CNS Research Institute, P.C. — Clementon, New Jersey, United States
• CRI Worldwide, LLC Kirkbride Center — Philadelphia, Pennsylvania, United States
• Benchmark Research — Austin, Texas, United States
• Benchmark Research - Fort Worth — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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