A phase II double blind, randomised, placebo controlled, multicentre study to assess the efficacy and safety of TA-NIC in maintaining smoking cessation when given in conjunction with Nicotine Replacement Therapy (NRT) - Maintenance of smoking cessation in smokers who have quit (TA-NIC/03)

• Conditions: Prevention of relapse in smokers who have quit.

• Registration Number: EUCTR2005-000922-22-GB
• Lead Sponsor: Xenova Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-06
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1. Age = 18 years
2. Male or female (females must be either of non child bearing potential, i.e., either surgically sterilised or post menopausal) or must be using adequate contraception, have a negative pregnancy test and must agree to continue to use this method of contraception until 3 months after the last immunisation. Acceptable contraceptive methods are oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence or partner vasectomy are not acceptable methods.
3. A smoker” who has smoked on a regular basis for a least a year and is currently smoking at least 10 cigarettes per day
4. Motivated to quit
5. In good general health as determined by medical history, general clinical examination and laboratory tests and a WHO performance status of 0 or 1
6. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known immunodeficiency
2. Patients taking medication known to have significant immunosuppression such as systemic glucocorticoid therapy (inhalers and topical formulations are permitted)
3. History of sensitivity to aluminium hydroxide gel
4. History of severe adverse reaction to cholera vaccine
5. Subjects taking medication that contains bupropion
6. History of substance abuse
7. Known allergy to components of NiQuitin CQ® patch
8. Non-cigarette tobacco use
9. Previous vaccination with TA-NIC
10. Participation in another clinical trial within thirty days prior to study entry
11. Women who are pregnant, lactating or who are planning to become pregnant.
12. Any subjects with a lab value outside the normal range, unless the value has been justified by the investigator in writing
13. Any other factor that in the opinion of the investigator would make the subject unsuitable for the trial e.g. alcohol abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified