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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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:2022-000692-39
    Sponsor's Protocol Code Number:IVY
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-03-31
    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 number2022-000692-39
    A.3Full title of the trial
    Safety, tolerability and immunogenicity of intradermal mRNA SARS-CoV2 vaccination in patients with Fibrodysplasia Ossificans Progressiva
    Veiligheid, tolerabiliteit en immunogeniciteit van intradermale injectie van mRNA SARSCoV-2 vaccin in patiënten met Fibrodysplasia Ossificans Progressiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and protection after vaccination against SARS-CoV-2 in the skin of patients with Fibrodysplasia Ossificans Progressiva
    Veiligheid en bescherming na vaccinatie tegen SARS-CoV-2 in de huid van patiënten met Fibrodysplasia Ossificans Progressiva
    A.3.2Name or abbreviated title of the trial where available
    IVY
    A.4.1Sponsor's protocol code numberIVY
    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 SponsorAmsterdam University Medical Center
    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 supportAmsterdam University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam University Medical Center
    B.5.2Functional name of contact pointEMW Eekhoff
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204440530
    B.5.5Fax number+31204444313
    B.5.6E-mailfop.amsterdam@vumc.nl
    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 Yes
    D.2.1.1.1Trade name COVID-19 Vaccine Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderEuropean Medicines Agency
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameCOVID-19 Vaccine Moderna
    D.3.2Product code EMEA/H/C/005791
    D.3.4Pharmaceutical form Concentrate and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal 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 No
    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
    Fibrodyplasia Ossificans Progressiva (FOP)
    E.1.1.1Medical condition in easily understood language
    Genetic condition which causes abnormal formation of bone at abnormal
    locations such as in the muscles, tendons and ligaments.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10068715
    E.1.2Term Fibrodysplasia ossificans progressiva
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe and investigate safety and tolerability of the intradermal delivery of two fractional doses of 20 μg mRNA-1273 in patients with Fibrodysplasia Ossificans Progressiva.
    E.2.2Secondary objectives of the trial
    To compare the immunogenicity of patients with FOP after intradermal delivery of two fractional doses of 20 μg mRNA-1273 with that of two doses of 20 μg mRNA-1273 vaccine through intramuscular delivery and intradermal delivery on Day 43, as previously investigated in LUMC cohort of healthy adults
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    • Fibrodysplasia ossificans progressiva as determined by confirmation of any causative genetic mutation in the ACVR1 gene as previously described (1).
    • 18 years or older
    • Participants who are willing and able to comply with all scheduled visits, vaccination tests and other study procedure
    • Capable of giving personal signed consent as described in appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and this protocol
    • Females only: female volunteers of childbearing potential (i.e. have a uterus and are neither surgically sterilised nor post-menopausal) must not be pregnant or breastfeeding. They should agree to use adequate contraception at least up to four weeks following the final dose of mRNA-1273 vaccine.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
    • Receipt of medications intended to prevent SARS-CoV-2 infection.
    • Current clinical complaints consistent with SARS-CoV-2 infection (three or more of the following complaints: headache, loss of smell, sore throat, hoarseness, cough, chest pain, shortness of breath, fatigue, diarrhea, fever).
    • SARS-CoV-2 vaccination 6 months prior to participation.
    • Immunosuppressed individuals with known or suspected immunodeficiency, as determined by history.
    • Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
    • Women who are pregnant or breastfeeding.
    • Planned pregnancy within four weeks after the final injection.
    • SARS-CoV-2 PCR-positive EMA approved lateral flow test at the screening before receipt of fist vaccine dose
    • Receipt of any other non-study vaccine within 28 days, before first study dose.
    • Anticipated receipt of any other non-study vaccine within 28 days, after last study dose administration.
    E.5 End points
    E.5.1Primary end point(s)
    • Nature, frequency and severity of local reactions. Solicited adverse events include: pain, redness and swelling at the injection site and pain and swelling at the regional lymph nodes
    • Nature, frequency and severity of systemic events. Solicited adverse events include: flare-up, fever, fatigue, headache, chills, vomiting, diarrhoea, new or worsened muscle pain, and new or worsened joint pain.
    • Use of corticosteroids, antipyretics and painkillers
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study
    E.5.2Secondary end point(s)
    • SARS-CoV 2 WT neutralising antibody titres rate on Day 1 and Day 43
    • SARS-CoV-2-spike protein–specific binding IgG level on Day 1 and Day 43
    • B-cell and T-cell responses on day 1 and day 43
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 and Day 43
    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 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 No
    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 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 No
    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 No
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 10
    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 No
    F.3.2Patients Yes
    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 state10
    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)
    Standard treatment
    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 Decision2023-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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