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    Summary
    EudraCT Number:2021-003618-37
    Sponsor's Protocol Code Number:SARS-CoV-2_booster_IS
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-28
    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 ConcernedNorway - NOMA
    A.2EudraCT number2021-003618-37
    A.3Full title of the trial
    REVACCINATION OF IMMUNOSUPPRESSED PATIENTS WITH POOR/NO SARS-COV-2 VACCINE RESPONSE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Booster dose of SARS-CoV-2 vaccine to patients with suboptimal response to previous doses.
    A.4.1Sponsor's protocol code numberSARS-CoV-2_booster_IS
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportOslo University Hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointJohn Torgils Vaage
    B.5.3 Address:
    B.5.3.1Street AddressSognsvannsveien 20
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number4723070000
    B.5.5Fax number4723073865
    B.5.6E-mailjtvaage@ous-hf.no
    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 Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameSARS-CoV-2 mRNA
    D.3.4Pharmaceutical form Concentrate for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    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.IMP: 2
    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 Spikevax
    D.2.1.1.2Name of the Marketing Authorisation holderModerna Biotech Spain, S.L
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameSARS-CoV-2 mRNA
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    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
    Patients with immune deficiency without proper response to previous SARS-CoV-2 vaccine doses.
    E.1.1.1Medical condition in easily understood language
    Vaccination for protection against COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10003816
    E.1.2Term Autoimmune disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074555
    E.1.2Term Transplantation complication
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10003921
    E.1.2Term B-cell unclassifiable lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the immune response of a third SARS-CoV-2 mRNA vaccine dose in immunosuppressed patients with no or suboptimal vaccine response after the second dose.
    To investigate adverse events potentially linked to the third/fourth vaccine dose.
    E.2.2Secondary objectives of the trial
    To investigate the immune response of a fourth SARS-CoV-2 mRNA vaccine dose in solid organ transplant recipients with no or suboptimal vaccine response after the third dose and to investigate the sustained immune response long-term.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients already included in one of the following ongoing vaccine observational subprotocols:
    • SARS-CoV-2 cellular and humoral immune response following vaccination of kidney transplant recipients and healthy controls
    • SARS-CoV-2 serological vaccine response in patients at Oslo University Hospital
    • Vaccine responses in MS: Nevrovax.
    • A Norwegian study of vaccine response to COVID-19 vaccines in patients using immunosuppressive medication within rheumatology and gastroenterology – The Nor-vaC study
    • Immunological response to Covid-19 vaccination in Lymphoma patients treated with Rituximab and in Bone marrow Transplanted patients.
    • Patients with an interval between the first and second vaccine dose according to drug label; 3 weeks for Comirnaty and 4 weeks for SpikeVax.
    • Patients with no or impaired humoral immune response more than 3 weeks after two doses of SARS-CoV-2 mRNA vaccine (SARS-CoV-2 SPIKE IgG ≤100 AU).
    • Available for vaccination at a few centralized centers (OUS, AHUS, Diakonhjemmet Hospital, HUS).
    • Not participating in therapeutical intervention studies.
    • Adult patients (≥18 years).
    • For fourth dose: Solid organ transplant recipients with no or impaired humoral immune response 4 weeks after three doses of SARS-CoV-2 mRNA vaccine (SARS-CoV-2 SPIKE IgG ≤100 AU).
    E.4Principal exclusion criteria
    • The second/third vaccine dose less than 4 weeks prior to vaccination with the third/fourth dose.
    • Pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (not acceptable methods: progesterone-only oral hormonal contraception, male/female condom without spermicide or cap, diaphragm or sponge with spermicide).
    • Solid organ transplant recipients transplanted less than 6 months before the third dose vaccination.
    • Serious side effect of previous SARS-CoV-2 vaccination.
    • Allergic to any vaccine excipients.
    • Acute febrile illness or acute infection.
    • Received any vaccination against other infectious diseases within the last four weeks prior to the third dose.
    • Have experienced breakthrough SARS-CoV-2 infection during or following primary vaccination.
    • Participation in other vaccine studies.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: SARS-CoV-2 SPIKE/RBD IgG antibody levels 4 weeks after administration of the third vaccine dose.
    Safety: Hospital admissions or deaths due to vaccine adverse events 6 weeks after the third/fourth dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after administration of the third vaccine dose for the efficacy end point.
    6 weeks after administration of the third vaccine dose for the safety end point.
    E.5.2Secondary end point(s)
    SARS-CoV-2 SPIKE/RBD IgG antibody levels 4 weeks after administration of the fourth vaccine dose. Humoral immune response at 3- and 6-months and sustained response up to 1 year after the third/fourth dose. Cellular immune responses at 4 weeks, 3- and 6 months and sustained response up to 1 year after the third/fourth dose in a subset of patients. Length of sustained humoral immune response following three versus two doses or four versus two doses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 1 years after the third/fourth vaccine doses.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Patients vaccinated with only two mRNA doses
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 6500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4500
    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 state11000
    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 per patient group
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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