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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-001781-14
    Sponsor's Protocol Code Number:POX-MVA-005
    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:2006-02-02
    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 number2005-001781-14
    A.3Full title of the trial
    A partially randomized, partially double-blind, placebo-controlled Phase II non-inferiority study to evaluate immunogenicity and safety of one and two doses of MVA-BN (IMVAMUNE™) smallpox vaccine in 18-55 year old healthy subjects
    A.4.1Sponsor's protocol code numberPOX-MVA-005
    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 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 nameIMVAMUNE TM
    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 Ankara-Bavarian Nordic
    D.3.10 Strength
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2x10E8 TCID50 to per 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 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 placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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 8.0
    E.1.2Level PT
    E.1.2Classification code 10041197
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: The main objective of the trial is to evaluate the immunogenicity of MVA-BN® (IMVAMUNE TM) smallpox vaccine concerning the ELISA specific humoral immune response compared between a group of subjects with history of smallpox vaccination (Group 4: 1 dose MVA-BN®, 1 dose placebo) versus a group without history of smallpox vaccination (Group 1: 2 doses MVA-BN®), i.e. to prove that a single dose schedule would be sufficient to boost the immunity in a previously vaccinated population.

    Primary safety objective: To compare the four different vaccination groups with regard to ECG changes and cardiac symptoms.
    E.2.2Secondary objectives of the trial
    To compare the ELISA specific immune response of the four different vaccination groups - comparison combinations not done for the primary objective.

    To compare the four different vaccination groups with regard to immune response measured with a plaque reduction neutralization test (PRNT).

    To assess the kinetics of the immune responses after 1 (Group 2) and 2 (Group 1) doses of MVA-BN® (IMVAMUNE TM) in vaccinia naïve subjects.

    To compare the four different vaccination groups with regard to safety and reactogenicity.

    To compare the safety of one (Group 2) and two (Group 1) vaccinations with MVA-BN® (IMVAMUNE TM) in vaccinia-naïve subjects with placebo (Group 3) and historical / recently published data of Dryvax® immunization in vaccinia-naive subjects.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    All groups
    1. Male and female subjects between 18 and 55 years of age.
    2. Women 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 first 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 last 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 ≥ 2500/mm3 and ≤ 11,000/ mm3.
    7. Absolute neutrophil count (ANC) ≥ 1000/mm3.
    8. Negative urine glucose by dipstick or urinalysis.
    9. Hemoglobin ≥ LLN.
    10. Platelets 100 – 440/nl.
    11. Adequate renal function defined as:
    a. Serum creatinine without clinically significant findings.
    b. Urine protein ≤ 30 mg/dL or none or trace proteinuria (by urinalysis or dip stick).
    12. Adequate hepatic function defined as:
    a. Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant liver disease (healthy subjects without clinical disease with Morbus Meulengracht can be included).
    b. AST (SGOT), ALT (SGPT) and alkaline phosphatase without clinically significant findings.
    13. Electrocardiogram (ECG) without 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, 2 premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia).
    14. Availability for follow-up for the planned duration of the study (26 weeks after last vaccination).

    Groups 1, 2 and 3 (All vaccinia-naïve subjects) additionally:
    1. No history of known or suspected previous smallpox vaccination.
    2. No detectable vaccinia scar.


    Group 4 (All previously vaccinated subjects) additionally:
    1. History of previous smallpox vaccination (documented and/or typical vaccinia scar).
    2. Most recent smallpox vaccination ≥ 5 years.
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding women.
    2. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
    3. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
    4. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
    5. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
    6. 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 at the vaccination site are excluded.
    7. History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
    8. Clinically significant mental disorder not adequately controlled by medical treatment.
    9. 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.
    10. 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.
    11. History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
    12. Ten 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) NOTE: This criterion applies only to volunteers 20 years of age and older.
    13. History of intravenous drug abuse.
    14. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    15. Known allergy to egg or aminoglycoside (gentamicin).
    16. History of anaphylaxis or severe allergic reaction.
    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 within14 days prior or after study vaccination.
    19. Chronic administration (defined as more than 14 days) of systemic immuno-suppressant drugs during a period starting from six months prior to administration of the vaccine and ending at study conclusion. (Corticosteroid nasal sprays are permissible. Persons who have used topical and inhaled steroids can be enrolled after their therapy is completed).
    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 the first dose of the study vaccine, or planned administration of such a drug during the study period.
    23. Study personnel.
    E.5 End points
    E.5.1Primary end point(s)
    Primary immunogenicity variable: MVA -specific seroconversion rate derived from the ELISA specific antibody titers 2 weeks after the last vaccination (Group 1-3: Visit 4, Group 4: Visit 2).
    Seroconversion is defined as the appearance of antibody titers ≥ 1:50 in a vaccinia specific IgG ELISA for initially seronegative subjects or twofold increase of the antibody titer compared to the pre-existing baseline titer for subjects with a pre-existing antibody titer in the ELISA.

    Priamary safety variable: Occurrence, relationship and intensity of any specific or unspecific ECG change at any time during the study.

    Occurrence, relationship and intensity of any other cardiac symptom at any time during the study.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity of the IMP
    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 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 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
    The trials ends for each individual subject with an examination at a follow-up visit 182-210 days after the last vaccination. The end of the entire trial is defined as the last subject having performed this last follow-up visit.
    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 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) 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 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 2006-02-02. 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 state800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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 the discontinuation will be obtained. The date of the last 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 Visit 5 for Group 1, 2 and 3 and Visit 3 for Group 4 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 Decision2006-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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