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    Summary
    EudraCT Number:2021-000673-83
    Sponsor's Protocol Code Number:TJB2101
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-19
    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 number2021-000673-83
    A.3Full title of the trial
    Impact of the immune system on response to COVID-19 vaccine in allogeneic stem cell recipients
    Impact du système immunitaire sur la réponse au vaccin COVID-19 chez les patients ayant reçu une allogreffe de cellules souches hématopoiétiques
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of the immune system on response to COVID-19 vaccine in allogeneic stem cell recipients
    Impact du système immunitaire sur la réponse au vaccin COVID-19 chez les patients ayant reçu une allogreffe de cellules souches hématopoiétiques
    A.3.2Name or abbreviated title of the trial where available
    Cov-Allo
    A.4.1Sponsor's protocol code numberTJB2101
    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 SponsorCHU de Liège
    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 supportfederal governance
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Liège
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de l'Hôpital 1
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3243667201
    B.5.5Fax number3243668855
    B.5.6E-mailf.baron@ulg.ac.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 AuthorisationBelgium
    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 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 INNComirnaty
    D.3.9.2Current sponsor codePfizer Manufacturing Belgium NV
    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 number100
    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
    Allogeneic hematopoietic stem cell recipients
    Receveurs d'une allogreffe de cellules souches hématopoïétiques
    E.1.1.1Medical condition in easily understood language
    Full protocol (n=50) : Allogeneic hematopoietic stem cell transplantation (allo-HCT) recipients
    Previously vaccinated patients (n=20) : allo-HCT recipients who received two doses of the vaccine
    Receveurs d'une allogreffe de cellules souches hématopoïétiques
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our central question is whether allo-HCT recipients can develop protective immunity against COVID-19 upon vaccination. This question would help the hematologist to provide recommendation/best treatment for these patients. In this pilot project Cov-Allo, this question will be addressed in a cohort in which allo-HCT recipients will be vaccinated with the mRNA available COVID-19 vaccine according to the Belgian vaccination program. The primary objective is to assess immune response after administration of the vaccine (Comirnaty®; Pfizer-BioNTech) in a population of 50 patients allo-HCT recipients. A co-primary objective is to assess immune response to a third dose of the Comirnaty® vaccine these 50 patients as well as in another 20 allo-patients previously given two doses of the Comirnaty® vaccine outside of the current study.
    E.2.2Secondary objectives of the trial
    Full protocol (n=50)
    • To study the evolution and duration of immune response after vaccination (analyze anti-RBD IgG titers performed on days 0 and 28 after third dose and at 6 and 12 months
    • analyze the titer of neutralizing antibodies 28 days after the second dose as well as days 0, 28 and at 6 and 12 months after the third dose
    • To investigate the safety of the Comirnaty vaccine. Safety will be reported in terms of incidence and severity of systemic adverse events (AEs)

    Third dose vaccine only (n=20)
    • To study the evolution and duration of the immune response after vaccination (analyze anti-RBD IgG titers performed at day 28, 6 months and 12 months after the third dose)
    • investigate the efficacy of immune response (assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of documented SARS-CoV-2 infection within12 months after the third dose)
    • investigate the safety of a third dose of the Comirnaty® vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Full protocol (3 vaccines, n=50)

    - prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment.
    - age> or = 18years at inclusion.
    - written informed consent

    Third dose vaccine only (n=20)

    - Prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment.
    - age > or = 18years at inclusion.
    - written informed consent
    - Prior vaccination with 2 doses of the Comirnaty® vaccine after allo-HCT
    E.4Principal exclusion criteria
    Full protocol (3 vaccines, n=50)

    - HIV seropositivity
    - Pregnancy
    - Active malignant disease at inclusion
    - Current grade III-IV acute GVHD
    - In vitro T-cell depletion of the graft if vaccination within the 6 months after transplantation.
    - Rituximab administration in the 6 months prior to study inclusion
    - Prior documented COVID-19 infection occurring after allo-HCT

    Third dose vaccine only (n=20)

    - HIV seropositivity
    - Pregnancy
    - Active malignant disease at inclusion
    - Current grade III-IV acute GVHD
    - Rituximab administration in the 6 months prior to study inclusion for the third dose
    - Subjects who were not previously vaccinated with a COVID-19 vaccine according to the scheme mentioned above
    - Subjects who already received a third booster dose of a COVID-19 vaccine
    - Prior documented COVID-19 infection occurring after allo-HCT
    E.5 End points
    E.5.1Primary end point(s)
    There are two co-primary endpoints

    First co-primary endpoint
    The first primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after vaccination (day 28 after second dose) in allo-HCT recipients. Antibody titers to the full Spike, S1, S2, RBD (receptor binding domain) and N (nucleocapsid) protein of SARS-COV-2 will be measured quantitatively. For this measurement a Multiplex SARS-COV-2 Immunoassay will be used. Since anti-RBD IgG is the most relevant antibody (best correlation with in vitro neutralisation), the presence of this antibody will also be tested with an in house anti-RBD IgG ELISA.

    Second co-primary endpoint

    The second co-primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after the third vaccination (day 28 after the third dose) in allo-HCT recipients (this will be the sole primary endpoint for the 20 patients included only for the third dose of the vaccine).


    A second co-primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after the third vaccination (day 28 after the third dose) in allo-HCT recipients (this will be the sole primary endpoint for the 20 patients included only for the third dose of the vaccine).
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28 after the third vaccination
    E.5.2Secondary end point(s)
    Full protocol (n=50)
    • To study the evolution and duration of the immune response after vaccination: using serology assays to analyze anti-RBD IgG titers performed at day of the third dose and on days 0 and 28 after third dose and at 6 months and 12 months after the third dose.
    • To analyze the titer of neutralizing antibodies 28 days after the second dose as well as 0 days, 28 days, and at 6 and 12 months after the third dose.
    o This will be assessed by the capacity of the antibodies to neutralize an infection with SARS-CoV-2 or pseudoviral particles in vitro. These methodologies are established and available at the laboratory of Sciensano (Isabelle Desombere; Co-worker of Cov-Allo).
    • To identify factors predicting response to vaccine in allo-HCT recipients.
    • To investigate the efficacy of the immune response. This will be assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2 infection within a time-frame from study inclusion to of 12 months after the start of the studythird dose.
    • In depth assessment of the immune response: by measuring the SARS-Cov2 specific T and B cell response and its evolution and longevity by sampling blood at different time points (B-cell immunity 7 days after the second dose (test performed at Sciensano), T-cell immunity 28 days after the second and the third doses).
    • To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). Safety will be reported in terms of incidence and severity of systemic adverse events (AEs). Adverse events will also be analyzed in terms of seriousness, relatedness, and expended or not. Incidence and nature of newly occurring immune related AEs of grade ≥ 3 according to the Common Terminology Criteria for Adverse Events version 5.0 including information on vaccine specific safety.

    Third dose vaccine only (n=20)

    • To study the evolution and duration of the immune response after vaccination: using serology assays to analyze anti-RBD IgG titers performed at day 28 after third dose and at 6 months and 12 months after the third dose.
    • To analyze the titer of neutralizing antibodies on 0 day, 28 days, and at 6 and 12 months after the third dose.
    o This will be assessed by the capacity of the antibodies to neutralize an infection with SARS-CoV-2 or pseudoviral particles in vitro. These methodologies are established and available at the laboratory of Sciensano (Isabelle Desombere; Co-worker of Cov-Allo).
    • To identify factors predicting response to the third dose vaccine in allo-HCT recipients.
    • To investigate the efficacy of the immune response. This will be assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2 infection within a time-frame of 12 months after the start of the third dose.
    • In depth assessment of the immune response: by measuring the SARS-Cov2 specific T and B cell response and its evolution and longevity by sampling blood at different time points, 0, 7 and 28 days after the third dose).
    • To investigate the safety of a third administration of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). Safety will be reported in terms of incidence and severity of systemic adverse events (AEs). Adverse events will also be analyzed in terms of seriousness, relatedness, and expended or not. Incidence and nature of newly occurring immune related AEs of grade ≥ 3 according to the Common Terminology Criteria for Adverse Events version 5.0 including information on vaccine specific safety.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study
    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 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 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
    When the database is cleaned and frozen.
    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 months9
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state70
    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 Decision2021-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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