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    Summary
    EudraCT Number:2008-005894-36
    Sponsor's Protocol Code Number:ZonMw61200014/Nabi4508
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-005894-36
    A.3Full title of the trial
    A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm Study to Assess Efficacy and Safety of 3’-aminomethylnicotine-P. aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or placebo, co-administered with varenicline (Champix®) as an Aid in Smoking Cessation.
    A.4.1Sponsor's protocol code numberZonMw61200014/Nabi4508
    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 SponsorZonMw
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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
    B.Sponsor: 2
    B.1.1Name of Sponsornabi biopharmaceuticals
    B.1.3.4CountryUnited States
    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 No
    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 nameNicVAX
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboInjection*
    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
    Smoking: Subjects must be smoking an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10053325
    E.1.2Term Smoking cessation therapy
    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 efficacy and safety of 400 g of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit.
    E.2.2Secondary objectives of the trial
    • To evaluate safety and immunogenicity,
    • To evaluate long term abstinence from Week 37-52,
    • To evaluate four week abstinence from Week 9-12
    • To evaluate abstinence from Week 37-52 for subjects who were intolerant to varenicline or who were non-abstinent from Week 9-12,
    • To evaluate point prevalence (7-day abstinence; PP) at 12, 26 and 52 weeks,
    • To evaluate relapse rate post week 12 among subjects with 4-week Continuous Abstinence status at 12 week.
    • To evaluate time to first Relapse among subjects with 4-week Continuous Abstinence status at 12 week,
    • To evaluate time to first Lapse among subjects with 4-week Continuous Abstinence status at 12 week.
    • To evaluate time between first Lapse and first Relapse among subjects with 4-week Continuous Abstinence status at 12 week,
    • To evaluate withdrawal symptoms using Minnesota Nicotine Withdrawal Scale, measured during Weeks 12-15, Weeks 26-29, and Weeks 49-52.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudy 1:
    MECHANISMS UNDERLYING THE EFFECTS OF NICOTINE VACCINATION FOR
    SMOKING CESSATION 23-10-2006, version 1
    Objectives:to show how the intervention with NicVAX, and subsequent cessation of smoking, affects the cognition-brain relationships and thereby provide information with regard to the mechanisms involved. The experiments in this project will use Cognitive Neuroimaging (f-MRI, s-MRI) as the primary research tool.

    Substudy 2:
    ETHICAL IMPLICATIONS OF NICOTINE VACCINATION FOR SMOKING CESSATION 23-10-2006, version 1
    Objectives: To investigate the views and underlying values of smokers and their family members regarding important aspects of the use of nicotine vaccination in smoking cessation, in preventing relapse or starting smoking and the moral implications of nicotine vaccination for personal and social responsibility for health.
    E.3Principal inclusion criteria
    a) Male or female, 18 - 65 years of age, who has provided written, informed consent, and who, in the opinion of the investigator, is likely to comply with all the requirements of the study.
    b) Good general health.
    c) Subjects must be smoking an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
    d) If a female of child-bearing potential: a negative urine pregnancy test, and be willing to use acceptable birth control during study participation (oral, injectable, implantable contraceptive; intrauterine device; or barrier method with spermacide).
    e) Alveolar carbon monoxide level > 8 ppm.
    E.4Principal exclusion criteria
    a) Prior exposure to NicVAX or any other nicotine vaccine.
    b) Any known allergic reaction to any components of the vaccine
    c) Evidence or history of clinically significant allergic reactions (seasonal allergies allowed).
    d) Use of systemic steroids, immunosuppressive agents or other medications within 30 days prior to administration of investigational product that might interfere with an immune response.
    e) Known history of cancer or cancer treatment within 60 months prior to administration of investigational product, except for treated basal cell or squamous cell carcinoma.
    f) Known infection with HIV, or congenital or other acquired immunodeficiency.
    g) Known history of illicit drug or alcohol abuse or dependence (except nicotine) within 12 months prior to administration of investigational product and for the study duration.
    h) Known history of serious psychiatric disorder within 3 months prior to administration of investigational product.
    i) Required treatment for depression within the past 12 months.
    j) History of current psychosis or bipolar disorder.
    k) Current use of antidepressants, antipsychotics, mood stabilizers, naltrexone.
    l) Clinically significant cardiovascular disease within the past 6 months. m) Hepatic or renal impairment.
    n) Serious or unstable disease within the past 6 months, such as:
    - Uncontrolled hypertension.
    - Severe chronic obstructive pulmonary disease.
    - SGOT (AST) of SGPT (ALT) greater than 150% ULN or total bilirubin greater than 110% ULN.
    - Elevated serum creatinine.
    - Other clinically significant laboratory abnormality.
    o) Body mass index >38 [calculated as weight (kg)/height2 (m)]
    p) Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder compliance.
    q) Use of any smoking cessation treatment, such as over the counter or prescription nicotine replacement therapy (NRT), varenicline, bupropion, clonidine, nortryptyline, mecamylamine within 30 days of the first administration of investigational product, or intention to participate in any other nicotine-related modification strategy outside the scope of this protocol.
    r) Intolerance to varenicline.
    s) Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chew, or marijuana use within the past month and not agreeing to abstain from use of these products during study participation.
    t) Use of Botox injections within 30 days prior to administration of investigational product and for the duration of the study.
    u) Use of any investigational vaccine 30 days prior to each administration of study product (licensed vaccines may be administered at any time with the exception of one week prior to and one week after administration of investigational product).
    v) Previous serious or unexpected adverse reaction to a vaccine, including Guillain-Barré syndrome.
    w) Anticipated inability to fulfill all visits and examination procedures throughout the study period (approximately 54 weeks).
    x) Receipt of an Investigational New Drug/Device 30 days prior to (or 5 half-lives, whichever is longer) administration of investigational product and for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    • Long term abstinence from Week 9-52 confirmed by self-reported smoking and exhaled carbon monoxide (CO).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned2
    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 Yes
    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
    Last visit of last subject undergoing the trial. The last subject can be included 52 weeks afer the first visit of the first subject.
    Visit 25 - Week 52 Day 364 ( 5 days); Final Visit or Early Termination Visit
    This visit will be conducted for all subjects upon termination from the study regardless of the number of injections that are administered or varenicline taken.
    After the last visit of the last subject, 24 months are planned for the analysis of data and writing of reports.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state600
    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 Decision2009-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
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