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    Summary
    EudraCT Number:2005-000922-22
    Sponsor's Protocol Code Number:TA-NIC/03
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2005-05-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-000922-22
    A.3Full title of the trial
    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)
    A.3.2Name or abbreviated title of the trial where available
    Maintenance of smoking cessation in smokers who have quit (TA-NIC/03)
    A.4.1Sponsor's protocol code numberTA-NIC/03
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorXenova Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTA-NIC
    D.3.2Product code TA-NIC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameTA-NIC protein conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of relapse in smokers who have quit.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-05-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state440
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 440
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-18
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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