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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2021-003710-39
    Sponsor's Protocol Code Number:IJB-COVID-001
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-24
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2021-003710-39
    A.3Full title of the trial
    COVID-19: Immune response in patients with cancer undergoing mRNA vaccination against SARS-CoV-2. I-SPARC study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID-19: Immune response in patients with cancer undergoing mRNA vaccination against SARS-CoV-2. I-SPARC study
    A.3.2Name or abbreviated title of the trial where available
    I-SPARC
    A.4.1Sponsor's protocol code numberIJB-COVID-001
    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 SponsorINSTITUT JULES BORDET
    B.1.3.4CountryBelgium
    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 supportROCHE
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT JULES BORDET
    B.5.2Functional name of contact pointCTSU
    B.5.3 Address:
    B.5.3.1Street AddressRue Meylemeersch N°90
    B.5.3.2Town/ cityAnderlecht
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.6E-mailcstu.isparc@bordet.be
    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 AuthorisationEuropean Union
    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 nameCOMIRNATY
    D.3.4Pharmaceutical form Concentrate for dispersion 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 INNtozinameran
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 AuthorisationEuropean Union
    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 nameSPIKEVAX
    D.3.4Pharmaceutical form Dispersion 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.3.9.3Other descriptive nameCOVID-19 mRNA vaccine Moderna (CX-024414)
    D.3.9.4EV Substance CodeSUB207171
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    adult cancer patients
    E.1.1.1Medical condition in easily understood language
    adult cancer patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084457
    E.1.2Term COVID-19 immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028997
    E.1.2Term Neoplasm malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the humoral immune response against SARS-CoV-2 at 6 months (+/- 4 weeks) after the 2nd dose of a mRNA anti-SARS-CoV-2 vaccine (baseline assessment).
    E.2.2Secondary objectives of the trial
    - To evaluate the duration of the humoral immune response against SARS-CoV-2 at 6 months (+/- 4 weeks) after the baseline assessment or at 6 months (+/- 4 weeks) after the boost with the 3rd dose, if a 3rd dose of the vaccine is administered until 12 months (+/- 4 weeks) after the 2nd dose by local / national health policy guidelines.
    - To measure the influence of underlying malignant disease on the magnitude and duration of humoral immune response to vaccination against SARS-CoV-2 at:
    i) 6 months (+/- 4 weeks) after the 2nd dose; and
    ii) 6 months (+/- 4 weeks) after baseline assessment or 6 months (+/- 4 weeks) after the boost with the 3rd dose, if a 3rd dose of the vaccine is administered until 12 months (+/- 4 weeks) after the 2nd dose by local / national health policy guidelines.
    - To evaluate safety of mRNA anti-SARS-CoV-2 vaccine 3rd dose.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Analysis of active humoral and cellular immune responses in vaccinated cancer subjects (version 1.0 - 15/09/2021, included in the main protocol)
    To explore changes in adaptive immune response against SARS-CoV-2 in cancer subjects vaccinated with anti-SARS-CoV-2 mRNA vaccine with the goal of identifying blood biomarkers of response to vaccination.
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria in order to be eligible for this study:
    1) Age ≥ 18 years old
    2) ECOG performance status ≤ 2
    3) Subjects with histologically or cytologically confirmed cancer diagnosis (invasive solid tumour or haematological malignancy)
    undergoing active systemic cancer treatment at the time of 1st dose of the anti-SARS-CoV-2 mRNA vaccine (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in
    - non-metastatic setting or
    - metastatic setting (only 1st line therapy )

    or undergoing follow-up after confirmed cancer complete remission without active cancer treatment for the last 12 months at the time of 1st dose of the anti-SARS-CoV-2 mRNA vaccine

    4) Life expectancy > 6 months
    5) Subjects who received the 2nd dose of mRNA platform vaccination against SARS-CoV-2 as per local guidelines within 6 months (maximum until 6 months and 3 weeks) prior to registration.
    6) Urine pregnancy test negative for all female subjects of childbearing potential within 7 days prior to subject enrolment.
    7) Signed Informed Consent form (ICF) obtained prior to any study related procedure.
    8) Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.
    E.4Principal exclusion criteria
    Subjects meeting one of the following criteria are not eligible for this study:
    1) Known pregnant and/or lactating women.
    2) Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study.
    3) Subjects with active diagnosis of acute leukaemia.
    4) Subjects treated with bone marrow transplant < 90 days before received vaccination against SARS-CoV-2.
    5) Subjects with a known history of HIV infection.
    6) COVID-19 infection in the last 28 days before receiving first dose of vaccination against SARS-CoV-2 and up to subject enrolment.
    7) Subjects receiving prolonged and/or high doses of systemic immunosuppressive therapies including corticosteroids during the last 28 days before receiving first dose of vaccination against SARS-CoV-2 and up to subject enrolment.8) Subjects who, for any reason, did not receive the 2nd dose of the anti-SARS-CoV-2 mRNA vaccine.
    9) Subjects that received the 3rd dose of anti-SARS-CoV-2 mRNA vaccine prior to study entry.
    10) Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform.
    11) Subjects with a known or suspected history of severe adverse reactions associated with a vaccine and/or with severe allergic reaction to vaccine components or anaphylaxis in the past.
    12) Subjects who have received any other licensed vaccines for other indications within 28 days prior to the 3rd dose, or who are planning to receive any other vaccine up to 14 days after the 3rd dose of the mRNA anti-SARS-CoV-2 vaccine (28 days for live attenuated vaccines). For influenza vaccination, a shorter interval or simultaneous administration is acceptable.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, at 6 months (+/- 4 weeks) after the 2nd dose of a mRNA anti-SARS-CoV-2 vaccine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of trial
    E.5.2Secondary end point(s)
    -The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, at 6 months (+/- 4 weeks) after the baseline assessment or at 6 months (+/- 4 weeks) after the 3rd dose if administered until 12 months (+/- 4 weeks) after the 2nd dose per local / national health policy guidelines.
    - The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, by underlying malignant disease, at:
    i) 6 months (+/- 4 weeks) after the 2nd dose; and
    ii) 6 months (+/- 4 weeks) after baseline assessment or 6 months (+/- 4 weeks) after the boost with the 3rd dose administered until 12 months (+/- 4 weeks) after the 2nd dose per local / national health policy guidelines.
    - The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, by cohort (specified in section 3), at:
    i) 6 months (+/- 4 weeks) after the 2nd dose; and
    ii) 6 months (+/- 4 weeks) after baseline assessment or 6 months (+/- 4 weeks) after the boost with the 3rd dose administered until 12 months (+/- 4 weeks) after the 2nd dose per local / national health policy guidelines.
    - The proportion of asymptomatic subjects with SARS-CoV-2 positive test, confirmed COVID-19 or severe COVID-19 infection with onset at least 14 days after the 2nd dose in subjects who had been without serologic or virological evidence of SARS-CoV-2 infection up to 14 days after the 2nd dose. Whenever reported in the patient’s charter/dossier, both the viral load and mutant strainsof SARS-CoV-2 related data will be collected in the eCRF for any subjects with SARS-CoV-2 infection.
    - Safety of 3rd dose of mRNA anti-SARS-CoV-2 vaccine, defined as the frequency, duration and severity of adverse reactions reported according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of trial
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    one arm trial, 3 cohorts of patients
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    The end of trial is declared when all the following criteria have been met:
    - The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints.
    - The database has been fully cleaned and frozen/locked for the final analysis.
    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 months3
    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 months3
    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: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 265
    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 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 state245
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 525
    F.4.2.2In the whole clinical trial 525
    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)
    A the discretion of the physician, in accordance with local practice
    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 Decision2022-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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