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    The EU Clinical Trials Register currently displays   41018   clinical trials with a EudraCT protocol, of which   6709   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2017-004582-27
    Sponsor's Protocol Code Number:RSV-MVA-013
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-004582-27
    A.3Full title of the trial
    A Phase 2a Randomized, Double-blinded, Placebo-controlled Trial to assess the Safety, Immunogenicity, and Efficacy of the recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a clinical study to assess the safety, immunogeniocity, and efficacy of a MVA-BN-RSV Vaccine against viral respiratory infection in a challenge setting in healthy volunteers.
    A.4.1Sponsor's protocol code numberRSV-MVA-013
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportBavarian Nordic A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBavarian Nordic GmbH
    B.5.2Functional name of contact pointElke Jordan
    B.5.3 Address:
    B.5.3.1Street AddressFraunhoferstrasse 13
    B.5.3.2Town/ cityMartinsried
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.6E-mailejo@bavarian-nordic.com
    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 nameMVA-BN-RSV
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 INNMVA-BN-RSV
    D.3.9.3Other descriptive nameMVA-BN-RSV
    D.3.9.4EV Substance CodeSUB191931
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5.0 x 10E8
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Upper and lower respiratory tract infections caused by Respiratory Syncytical Virus
    E.1.1.1Medical condition in easily understood language
    MVA-BN-RSV is a vaccine developed to protect against infections of the respiratory tract caused the virus RSV.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039247
    E.1.2Term RSV infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the effect of vaccination with MVA-BN-RSV vaccine on RSV viral load area under the curve (AUC) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs in healthy subjects after virus inoculation with a wild-type RSV A challenge virus
    E.2.2Secondary objectives of the trial
    -Assess the immunological responses over the study period
    -Assess the safety, tolerability and reactogenicity .
    -Assess the effect of IMP vaccination on RSV clinical signs and symptoms over time via time to start, peak, and cessation of RSV symptoms ) and RSV composite symptom score AUC after virus inoculation with a wild-type RSV A challenge virus.
    -Assess the difference btw the active vaccine and the placebo group in viral load AUC by quantitative RSV culture (qCulture) from nasopharyngeal swabs after virus inoculation with a wild-type RSV A challenge virus.
    -Assess the effects of IMP vaccination on viral shedding over time via descriptive statistics of the viral load AUC by qRT-PCR and by qCulture, and time to start, peak, and cessation of viral shedding (qRT-PCR and qCulture) after virus inoculation with a wild-type RSV A challenge virus.
    -Assess the effect of IMP vaccination on nasal mucus weight after virus inoculation with a wild-type RSV A challenge virus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
    2. Male or female, between 18 and 55 years old (extremes included) at screening.
    3. General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
    4. Willing to adhere to the prohibitions and restrictions specified in this protocol, including willingness to stay confined to the CPU for the required duration.
    5. Willingness to have samples stored for future research to investigate vaccine and RSV associated changes in immunity.
    6. Absent or low levels of pre-existing RSV neutralizing antibodies, as determined by PRNT° Strain A assay (≤ 30 % of average population).
    7. Female subjects should fulfil one of the following criteria:
    a. At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone >according to local lab values mIU/mL) prior to screening;
    b. Surgically sterile (bilateral oophorectomy, hysterectomy);
    c. Will use contraceptives as outlined in inclusion criterion 8 from screening to discharge.
    8. Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from at least 30 days prior to administration of the MVA-BN-RSV vaccine to until 30 days after virus inoculation with the challenge virus.
    Note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined double barrier method, oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, abstinence, sterilization, tubal ligation and vasectomy.
    9. Female subject has a negative pregnancy test at screening and admission to the CPU for virus inoculation.
    Note: Pregnancy testing will consist of a serum (beta-)human chorionic gonadotropin (HCG) test at screening and admission to the CPU and urine pregnancy tests at other visits, in all women of childbearing potential (WOCBP).
    10. Negative hepatitis panel (including hepatitis B surface antigen and anti-hepatitis C virus antibodies) and negative human immunodeficiency virus antibody and antigen screens at screening.
    11. Troponin I within normal limits
    E.4Principal exclusion criteria
    1. Has an acute or chronic medical condition that, in the opinion of the investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses, including but not limited to, neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immune suppression conditions.
    2. Laboratory parameters (such as complete or full blood count (CBC/FBC), serum biochemistry including aspartate aminotransferase (AST), alanine amino transferase (ALT), alkaline phosphokinase (ALP), bilirubin, or creatinine values), pulse rate and/or blood pressure, or ECG outside normal range and deemed clinically relevant by the investigator.
    3. Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the trial protocol.
    4. A medical, occupational, or family problem as a result of alcohol or illicit drug use during the 12 months prior to screening.
    5. Routine smoker (>4 cigarettes or other tobacco-based products per week) of a tobacco product or marijuana currently or in the past year prior to screening.
    6. Current alcohol abuse or addiction (positive alcohol breath test at screening or upon check-in at the clinical site).
    Excessive use of alcohol is an intake of >21 units per week for males and >14 units per week for females where one alcohol unit is defined as 10 mL or 8 g of pure alcohol. A single unit is equal to one 25 mL (single) measure of whisky (alcohol by volume [ABV] 40%), or a third of a pint of beer (190 mL; ABV 5-6%) or half a standard (175 mL) glass of wine (ABV 12%).
    7. Current illicit drug abuse (positive drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates at screening or upon admission to the clinical site) or addiction.
    8. Presence of any febrile illness (≥38.0°C oral) or symptoms suggestive of a viral respiratory infection within 2 weeks prior to vaccination.
    9. Subjects with a positive result on below-listed adventitious agent screening (qualitative PCR testing) within 2 days prior to virus inoculation (i.e., at admission to the CPU): Subjects will be excluded in case of a positive result for: influenza A, influenza B, RSV, Bordetella pertussis, Chlamydophila pneumoniae or Mycoplasma pneumoniae.
    10. Use of corticosteroids (including nasal preparations) or immunosuppressive drugs within 30 days before vaccination and ending at the last visit of the active trial phase. Topical corticosteroids are allowed.
    11. A history of anaphylaxis.
    12. 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, gentamycin, eggs or aminoglycosides) or challenge agent.
    13. A history of asthma within the past 10 years prior to screening, or a current diagnosis of asthma or reactive airway disease associated with exercise or allergic rhinitis, with the exception of seasonal hay fever, house dust mite or allergy to animals.
    14. Chronic Obstructive Airways Disease or any respiratory illness associated with reduced lung capacity or capability.
    15. A known immunodeficiency syndrome.
    16. History of or active autoimmune disease. Persons with vitiligo or hypothyroid disease taking thyroid hormone replacement are not excluded. History of Guillain-Barré syndrome or Reye’s syndrome.
    17. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, significant arrhythmia with or without corrective/ablative surgery, or any other heart condition under the care of a doctor.
    18. Chest pain (that is diagnosed as cardiac related) or trouble breathing on exertion. Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Heart, Lung and Blood Institute’s Risk Assessment Tool: http://cvdrisk.nhlbi.nih.gov/calculator.asp (NOTE: This criterion applies only to subjects 20 years of age and older). Receipt of a licensed vaccine within 30 days prior to or after vaccination.
    19. Receipt of a licensed vaccine within 30 days prior to or after vaccination.
    20. Receipt of blood or blood-derived products (including immunoglobulin) within 3 months prior to vaccination and ending at the last visit of the active trial phase. Receipt of packed red blood cells given for an emergent indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells emergently given during an elective surgery).
    21. Receipt of another investigational agent within 30 days preceding the trial vaccination
    22. Body mass index (BMI) less than or equal to 19.0 kg/m2 and greater than or equal to 35.0 kg/m2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint in this study is to compare the AUC of the RSV RNA log10 viral load determined by qRT-PCR from RSV A virus inoculation until discharge (11 days after virus inoculation) between the active vaccine group and the placebo group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    11 days after virus inoculation (challenge)
    E.5.2Secondary end point(s)
    Efficacy (post virus inoculation with a wild-type RSV A challenge virus)
    • Attack Rate: Attack rate will be defined as percentage of inoculated subjects with at least 2 consecutive NP swabs positive for RSV (shedding events) determined by qRT-PCR;
    • Viral load AUC by qRT-PCR from NP swabs from virus inoculation until discharge (11 days after virus inoculation);
    • Viral load AUC by qCulture from NP swabs from virus inoculation until discharge (11 days after virus inoculation);
    • Composite symptom score AUC based on the symptom score card from virus inoculation until discharge (11 days after virus inoculation);
    • Time to start and duration of viral shedding (RSV qRT-PCR);
    • Time to start and duration of viral shedding (RSV qCulture);
    • Time to start and duration of RSV sign and symptoms (symptom score card);
    • RSV challenge-associated clinical disease: frequency of upper respiratory infection, lower respiratory infection and individual symptom assessment;
    • Nasal mucus weight based on tissue paper collection.
    Safety (post vaccination with MVA-BN-RSV and post virus inoculation with a wild-type RSV A challenge virus)
    • Occurrence, relationship to the trial vaccine and severity of any serious adverse event (SAE);
    • Occurrence, relationship to the virus inoculation and severity of any SAE;
    • Occurrence of any grade 3 or higher adverse event (AE) at least possibly related to the trial vaccine within 4 weeks after vaccination but prior to inoculation;
    • Occurrence of any grade 3 or higher AE at least possibly related to virus inoculation with onset after virus inoculation until approximately 4 weeks post inoculation (Follow-up Visit 1);
    • Occurrence, severity and duration of solicited local AEs during the 8-day period (day of vaccination and the following 7 days) after vaccination;
    • Occurrence, relationship to the trial vaccine, severity and duration of solicited general AEs during the 8-day period (day of vaccination and the following 7 days) after vaccination;
    • Occurrence, relationship to the trial vaccine and severity of unsolicited AEs within 4 weeks after vaccination but prior to inoculation;
    • Occurrence, relationship to virus inoculation and severity of unsolicited AEs after virus inoculation until approximately 4 weeks post inoculation (Follow-up Visit 1);
    E.5.2.1Timepoint(s) of evaluation of this end point
    11 days after virus inoculation (challenge)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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.8.2.4Number of treatment arms in the trial2
    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 No
    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
    LVLS
    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 months8
    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 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.1.2.1Number of subjects for this age range: 72
    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 state72
    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)
    No plans for treatment after the trial has ended because this is a one time vaccination
    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 Decision2018-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-30
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