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    Summary
    EudraCT Number:2007-006297-28
    Sponsor's Protocol Code Number:POX-MVA-023
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-30
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2007-006297-28
    A.3Full title of the trial
    An open-label Phase II study to evaluate immunogenicity and safety of a single IMVAMUNE® booster vaccination two years after the last IMVAMUNE® vaccination in former POX-MVA-005 vaccinees
    A.4.1Sponsor's protocol code numberPOX-MVA-023
    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 SponsorBavarian Nordic A/S
    B.1.3.4CountryDenmark
    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 nameIMVAMUNE®
    D.3.2Product code MVA-BN®
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMVA-BN®
    D.3.9.3Other descriptive nameModified Vaccinia Virus Ankara-Bavarian Nordic
    D.3.10 Strength
    D.3.10.1Concentration unit TCID50/dose tissue culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1x10E8 per 0.5 ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy subjects - prevention of smallpox infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10041197
    E.1.2Term Smallpox
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the immune response elicited by a booster vaccination with IMVAMUNE® two years after the last vaccination with one or two doses of IMVAMUNE®.
    E.2.2Secondary objectives of the trial
    To provide data on safety of IMVAMUNE® from subjects previously vaccinated with one or two doses of IMVAMUNE® and boosted with one IMVAMUNE® vaccination two years after the last IMVAMUNE® vaccination.

    To compare study Groups 1 and 2 with regard to immunogenicity, safety and reactogenicity following the booster vaccination with IMVAMUNE®.

    To evaluate the long term persistence of anti-vaccinia antibody titers after two years in Groups 1, 2 and 4.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Blood draws for further development of validated assays to detect and quantify the specific immune response after a smallpox vaccination with IMVAMUNE®

    E.3Principal inclusion criteria
    Groups 1 and 2 (first 75 consenting subjects in each group to be vaccinated):
    1. Male and female subjects having participated in Group 1 or 2 of the study POX MVA-005 who completed the trial according to protocol.
    2. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
    3. Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
    4. Read, signed and dated informed consent document after being advised of the risks and benefits of the study in a language understood by the subject signed, and prior to performance of any study specific procedure.
    5. Troponin I within normal institutional limits.
    6. White blood cells ≥ 2,500/mm3 and ≤ 11,000/mm3.
    7. Absolute neutrophil count within normal limits.
    8. Negative urine glucose by dipstick or urinalysis.
    9. Hemoglobin within the laboratory reference ranges (unless the investigator considers the deviation to be not clinically significant).
    10. Platelets 100 – 440/nL.
    11. Adequate renal function defined as:
    • Serum creatinine without clinically significant findings.
    • Urine protein ≤ 30 mg/dL or none or trace proteinuria (by urinalysis or dip stick).
    12. Adequate hepatic function defined as:
    • Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant liver disease (healthy subjects without clinical disease; Morbus Meulengracht can be included).
    • AST (SGOT), ALT (SGPT), alkaline phosphatase without clinically significant findings.
    13. ECG without clinically relevant abnormal findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two PVC in a row, ST elevation consistent with ischemia).

    Group 4 (all subjects) and
    Groups 1 and 2 (subjects N > 75): blood draw only
    1. Male and female subjects having participated in study POX-MVA-005 who completed the trial according to protocol.
    2. Read, signed and dated informed consent document after being advised of the risks and benefits of the blood draw in a language understood by the subject signed, and prior to performance of the blood draw.

    Inclusion criteria for Amendment #3 (additional blood draws):
    1. POX-MVA-023 study participant, willing to participate voluntarily in the additional visit specifically for a blood draw
    2. Read, signed and dated ICF
    3. Strong immune responder (presence of high anti-vaccinia antibody titer; information provided by Bavarian Nordic to Harrison Clinical Research Deutschland GmbH)
    4. Good general health with no acute illnesses
    5. Body weight > 50 kg
    E.4Principal exclusion criteria
    Groups 1 and 2 (first 75 consenting subjects in each group to be vaccinated:
    1. Participation in another study with a smallpox vaccine after the POX-MVA-005 study.
    2. Pregnant or breast-feeding women.
    3. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
    4. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
    5. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
    6. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
    7. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous site of cancer.
    8. History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
    9. Clinically significant mental disorder not adequately controlled by medical treatment.
    10. Any condition which might interfere with study objectives or would limit the subject’s ability to complete the study or to be compliant in the opinion of the investigator.
    11. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
    12. History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
    13. Twenty percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program’s risk assessment tool. (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof)
    14. History of intravenous drug abuse.
    15. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. tris (hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, aminoglycosides (gentamycin).
    16. History of any anaphylactic shock or severe allergic reaction requiring immediate treatment.
    17. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
    18. Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after study vaccination.
    19. Chronic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent) via any administration route per day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at study conclusion (Visit 4).
    20. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
    21. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
    22. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding administration of the study vaccine, or planned administration of such a drug during the study period.

    Group 4 (all subjects) and
    Groups 1 and 2 (subjects N > 75): blood draw only
    1. Participation in another study with a smallpox vaccine after the POX-MVA-005 study.
    2. Any condition which might interfere with a blood draw.

    Exclusion criteria for Amendment #3 (additional blood draws):
    1. Clinical signs of anemia
    2. Blood loss ≥ 500 ml (e.g. blood donation) within the last 3 months
    3. Pregnancy or lactation
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    Percentage of subjects with either an appearance of antibody titers ≥ 50 in a vaccinia-specific ELISA for initially seronegative subjects, or an increase of the antibody titer compared to the baseline titer for subjects with a pre-existing antibody titer derived from the individual peak response at either Visit 2, 3 or 4.

    Secondary Endpoints:
    ELISA-specific percentage of subjects with either an appearance of antibody titers ≥ 50 for initially seronegative subjects, or an increase of the antibody titer compared to the baseline titer for subjects with a pre-existing antibody titer for all individual blood sampling time-points.

    Kinetics and magnitude of the humoral immune response measured by ELISA.

    Percentage of subjects with either an appearance of antibody titers ≥ 6 in a vaccinia-specific PRNT using Vaccinia Virus Western Reserve (VV-WR) as the antigen for initially seronegative subjects, or an increase of the antibody titer compared to the baseline titer for subjects with a pre-existing antibody titer in the PRNT.

    Kinetics and magnitude of the humoral immune response measured by PRNT.

    Correlation analysis between antibody titers measured by ELISA and PRNT.

    It is assumed that the ELISA and PRNT data are log normally distributed. Therefore, the titers will be transformed with log 10 performing the correlation analysis.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity; Sub-study: further assay development; blood draw to obtain anti-vaccinia antibodies.
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    subjects previously vaccinated once with IMP versus subjects previously vaccinated twice with IMP
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Six study visits are scheduled for each subjects with a total study duration of up to 36 weeks. The trial ends for each individual subject with an examination at a follow-up visit 182 to 210 days after the vaccination. The end of the entire trial is defined as the last subject having performed the follow-up visit at day 182 to 210.
    Sub-study(45 subj.). Blood draw at V4 or at additional visit as close as possible after V4, but before V5.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If a subject discontinues prior to completion of the study, the date and reason for discontinuation will be obtained. The date of the dose of study medication will also be obtained.
    Once a subject receives the IMP he/she must be followed for safety as stated in the protocol. From the time of discontinuation, all diagnostic procedures and evaluations scheduled for Visit4 should be performed.
    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 Decision2008-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-09
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