Prevention of relapse in smokers who have quit.
Conditions
Interventions
Product Name: TA-NIC
Product Code: TA-NIC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: N/A
Other descriptive name: TA-NIC protein conjugat
Sponsors
Xenova Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of TA-NIC on the maintenance of abstinence from smoking 26 weeks after start of vaccination. This will be measured by serum cotinine at week 26, supported by self reported abstinence in the 30 days immediately prior to the 26 week visit. ;Secondary Objective: To investigate any relationship between maintenance of abstinence and antibody levels. To investigate any relationship between maintenance of abstinence and baseline nicotine dependence, as measured by Fagerstrom score and baseline cotinine. To evaluate the effect of TA-NIC on the proportion of smokers who are quit at Week 4 and Week 12 as measured by CO breath test, supported by self reported abstinence in the 14 days immediately prior to each visit. To evaluate the effect of TA-NIC on the proportion of smokers who have remained quit, as measured by continuous abstinence between Weeks 26 and 52, supported by CO breath test and serum cotinine at Weeks 26, and 52. To assess the use of smoking cessation aids from Week 0 to Week 22. To assess the safety and tolerability of TA-NIC. To assess the immunogenicity of TA-NIC. ;Primary end point(s): The primary endpoint of the study is the efficacy of TA-NIC in preventing smoking relapse 26 weeks after immunisation with six injections of TA-NIC or placebo over 12 weeks from Week 0. This will be assessed by 30 day period prevalence 26 weeks after first vaccination. Smoking cessation will be defined as a cotinine below 13.7 ng/ml at the 26 Week visit supported by self reported non-smoking for 30 days immediately prior to the 26 week visit. Subjects who do not attend the clinic for the Week 26 assessment will be deemed to be smokers at that time point. | — |
Countries
United Kingdom
Outcome results
None listed