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    Summary
    EudraCT Number:2021-004923-34
    Sponsor's Protocol Code Number:RSV-MVA-004
    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:2022-02-18
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-004923-34
    A.3Full title of the trial
    A Randomized, Double-blind, Phase 3 Trial to Assess Clinical
    Efficacy, Safety and Reactogenicity of the Recombinant
    MVA-BN®-RSV Vaccine in Adults ≥60 Years of Age
    Randomisierte, doppel-blinde Phase 3 klinische Studie, um die klinische Wirksamkeit, Sicherheit und Reaktogenität eines rekombinanten MVA-BN-RSV Impfstoffs in Erwachsenen ≥60 Jahre zu untersuchen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study to assess the efficacy of an RSV vaccine in elderly adults above 60 years of age
    Klinische Studie zur Wirksamkeit und Sicherheit eines RSV Impfstoffs in Erwachsenen über 60 Jahre
    A.4.1Sponsor's protocol code numberRSV-MVA-004
    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 pointclinical-mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFraunhoferstrasse 13
    B.5.3.2Town/ cityPlanegg (Martinsried)
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-mailbox@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.3.2Product code MVA-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.3.11 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 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
    respiratory syncytial virus disease
    E.1.1.1Medical condition in easily understood language
    Viral respiratory disease caused by RSV
    Virale Atemwegserkrankung verursacht durch 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066742
    E.1.2Term Respiratory syncytial virus infection prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical efficacy of MVA-BN-RSV vaccine against lower respiratory tract disease (LRTD) associated with RSV.

    The estimand corresponding to the primary objective to assess vaccine efficacy is defined as 1 minus the hazard ratio of LRTD associated with RSV infection in the 2 vaccination groups in the population who are randomized and receive the study vaccination, regardless of early termination during the RSV season.
    E.2.2Secondary objectives of the trial
    To assess the clinical efficacy of MVA-BN-RSV vaccine against acute respiratory disease (ARD) associated with RSV.

    The estimand corresponding to this secondary objective of assessing vaccine efficacy is defined as 1 minus the hazard ratio of ARD associated with RSV disease in the 2 vaccination groups in the population who are randomized and receive the study vaccination, regardless of early termination during the RSV season.

    To assess clinical efficacy of MVA-BN-RSV vaccine against complications or hospitalization related to confirmed RSV disease.

    To assess safety and reactogenicity of the MVA-BN-RSV vaccine in medically stable subjects ≥60 years of age.

    To assess the RSV-specific humoral and cellular immunity elicited by MVA-BN-RSV in a subset of the study population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects ≥60 years of age.
    2. Informed Consent signed by the subject.
    3. Subjects may have one or more chronic medical conditions e.g., mild to moderate underlying illnesses such as chronic cardiac diseases and chronic lung diseases (asthma and chronic obstructive pulmonary disease [COPD]), congestive heart failure (CHF), hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or
    hypothyroidism, that is clinically stable as assessed by the investigator.
    4. Absence of known, current, and life-limiting diagnoses that render survival to completion of the protocol unlikely.
    5. Ability to comply with trial requirements, which necessitates access to transportation to on-site visits, including symptom visits for a nasopharyngeal swab.
    6. Willingness and ability to utilize an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and record all per protocol required data
    during the surveillance period.
    7. For women of childbearing potential (WOCBP), agreement to use an acceptable method of contraception during the trial and a negative urine pregnancy test within 24 hours prior to vaccination.
    E.4Principal exclusion criteria
    1. History of or current clinical manifestation of any serious medical condition that in the opinion of the investigator would compromise the safety of the subject, confound data interpretation, or would limit the subject’s ability to complete
    the trial.
    2. History of or active autoimmune disease, including diabetes mellitus type I. Vitiligo or hypothyroidism requiring thyroid
    replacement therapy are not exclusions. Rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment is not an exclusion.
    3. Known or suspected impairment of immunologic functions, including chronic inflammatory bowel disorders.
    4. Clinically significant mental disorder that would prevent patients from giving informed consent and complying with study procedures (e.g., completion of the electronic diary).
    5. Active or recent (within 6 months before enrollment) history of chronic alcohol abuse.
    6. History of a serious reaction to any prior vaccination or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
    7. 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, ciprofloxacin; this includes:
    • Known allergy to eggs or aminoglycosides.
    • History of anaphylaxis or severe allergic reaction to any
    vaccine.
    8. Any administration or planned administration of:
    • A licensed live or vector-based vaccine within 30 days
    prior to or after trial vaccine administration.
    • A licensed inactivated or ribonucleic acid (RNA)-based vaccine within 14 days prior to or after trial vaccine administration.
    9. Previous vaccination with an RSV vaccine, or any planned vaccination with an RSV vaccine other than the trial vaccine.
    10. Planned chronic, systemic administration (defined as more than 14 days) of >10 mg prednisone (or equivalent)/day or any other systemic use of immune-modifying drugs during a
    period starting from 3 months prior to first administration of the trial vaccine and ending at the End of Study Visit (EOS).
    The use of topical, inhaled, ophthalmic and nasal
    glucocorticoids is permitted.
    11. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to first administration of the trial vaccine and
    during the trial.
    12. Known uncontrolled coagulation disorder. Anticoagulant treatment under adequate control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation are permitted.
    13. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days prior to the administration of the trial vaccine, or planned administration of such a drug or vaccine between enrollment in the trial and until 4 weeks after the trial vaccine administration.
    14. Involvement with this trial as research personnel.
    15. Planned leave or holiday of 4 consecutive weeks or more during the RSV season covered by the study, that would prohibit the reporting of ARI cases and attendance at symptom visits.
    16. Pregnancy or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of LRTD (≥3 symptoms) associated with RSV until the end of one RSV season (up to 12 months after vaccination). RSV-associated LRTD is defined by the presence of clinical evidence of at least 3 sign or symptom of ARD (see below) and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR) (nasopharyngeal (NP) swab to be collected within 5 days of symptom onset; preferably within 72 hours of symptom onset).

    • hypoxemia (oxygen saturation <92% at rest in conjunction with an at least 3% decrease from baseline)
    • respiratory rate >25 breaths/Min
    • imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia
    • new wheezing or worsening of pre-existing wheezing
    • new shortness of breath or worsening of pre-existing shortness of breath
    • new cough or worsening of pre-existing cough
    new sputum production or worsening of pre-existing sputum production

    Occurrence of LRTD (≥2 symptoms) associated with RSV until the end of 1 RSV season (up to 12 months after vaccination). RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD (see below) and at least 2 (for less severe disease) of the following signs or symptoms with onset ≥14 days following vaccination until the end of 1 RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR) (nasopharyngeal (NP) swab to be collected within 5 days of symptom onset; preferably within 72 hours of symptom onset).

    • hypoxemia (oxygen saturation <92% at rest in conjunction with an at least 3% decrease from baseline)
    • respiratory rate >25 breaths/Min
    • imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia
    • new wheezing or worsening of pre-existing wheezing
    • new shortness of breath or worsening of pre-existing shortness of breath
    • new cough or worsening of pre-existing cough
    • new sputum production or worsening of pre-existing sputum production

    ARD symptoms include:
    • rhinorrhoea
    • nasal congestion
    • pharyngitis
    • earache
    • new cough or worsening of pre-existing cough
    • new wheezing or worsening of pre-existing wheezing
    • new sputum production or worsening of pre-existing sputum production
    • new shortness of breath or worsening of pre-existing shortness of breath
    • fever >100°F / >37.8°C (oral temperature)
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of 1 RSV season, up to 12 months
    E.5.2Secondary end point(s)
    Efficacy
    (Key secondary) Occurrence of ARD associated with RSV until the end of one RSV season (up to 12 months after vaccination).
    RSV-associated ARD is defined by the presence of either one (1) ARD symptom lasting for at least 24 hours or two (2) simultaneously occurring ARD symptoms (irrespective of duration), with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination).
    RSV disease must be laboratory confirmed by PCR (NP swab to be collected within 5 days of symptom onset; preferably within 72 hours of symptom onset).

    Occurrence of complications related to PCR-confirmed RSV disease.

    Occurrence of hospitalization due to confirmed RSV disease or due to any complication related to RSV-confirmed respiratory disease.

    Occurrence of LRTD (severe LRTD) associated with RSV until the end of one RSV season (up to 12 months after vaccination). RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD (see above) and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR) (nasopharyngeal (NP) swab to be collected within 5 days of symptom onset; preferably within 72 hours of symptom onset).
    • hypoxemia (oxygen saturation <92% at rest in conjunction with an at least 3% decrease from baseline)
    • respiratory rate >25 breaths/Min
    • imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia


    Safety
    Occurrence of any serious adverse events at any time during the trial period.
    Occurrence of any grade 3 or higher adverse events assessed as related to study vaccine within 29 days after vaccination.
    Occurrence of solicited local adverse events (pain, swelling, pruritus, erythema, induration) within 8 days after vaccination.
    Occurrence of solicited systemic adverse events (body temperature, headache, fatigue, myalgia, nausea, chills) within 8 days after
    vaccination.
    Occurrence of any unsolicited adverse events within 29 days after vaccination.

    Immunogenicity (selected sites)
    RSV-specific serum IgG antibody titers 2 weeks, 1 year and 2 years after vaccination.
    RSV-specific serum neutralizing antibody titers 2 weeks, 1 year and 2 years after vaccination (subtype A and B).
    RSV-specific T-cell responses measured 1 week, 1 year and 2 years after vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of 1 RSV season, up to 12 months
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned15
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    Germany
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 2400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21600
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state2500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 24000
    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)
    None
    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 Decision2022-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-01
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