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    Summary
    EudraCT Number:2021-000461-33
    Sponsor's Protocol Code Number:P2020_312
    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:2021-02-04
    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 number2021-000461-33
    A.3Full title of the trial
    Covid-19: Sars-Cov2 vaccination in hemodialysis patient: a phase IV study of the immunogenicity and its determinants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Covid-19: Sars-Cov2 vaccination in hemodialysis patient: a phase IV study of the immunogenicity and its determinants
    A.3.2Name or abbreviated title of the trial where available
    NEPHRO-VAC hemodialysis
    A.4.1Sponsor's protocol code numberP2020_312
    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 SponsorHopital Erasme, Université Libre de Bruxelles
    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 organisationHopital Erasme, Université Libre de Bruxelles
    B.5.2Functional name of contact pointdata manager
    B.5.3 Address:
    B.5.3.1Street AddressRoute de Lennik 808
    B.5.3.2Town/ cityAnderlecht
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.4Telephone numberBelgi025553334
    B.5.5Fax numberBelgi025556499
    B.5.6E-maildelphine.kemlin@erasme.ulb.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.3.9.3Other descriptive nameCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) No
    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
    Chronic hemodialysis patients
    E.1.1.1Medical condition in easily understood language
    Chronic hemodialysis patients
    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
    In the year 2020, the COVID19 pandemic caused by the Sars-Cov2 virus was responsible for a high mortality rate particularly in hemodialysis patients. The recent availability of anti-Sars-Cov2 vaccines could protect them from severe disease. However, it is widely accepted that vaccine responses are much weaker in this populations compared to healthy controls. The primary objective is to assess the immune response to SARS-Cov2 vaccination (vaccine BNT162b2 Comirnaty®; Pfizer- BioNTech) in 120 hemodialysis patients. The initial schedule of vaccination included two doses of BNT 162b2 at D0 and D21.
    Due to new SARS-CoV-2 variants and waning immunity, additional SARS-CoV-2 vaccinations may be necessary. This amendment concerns the follow-up of the immune response, both in naïve and previously infected patients, after additional SARS-CoV-2 vaccinations done in the framework of the national vaccination program is highly relevant.
    E.2.2Secondary objectives of the trial
    - to assess the safety of immunization by the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech) after two doses
    - to study the duration of the immune response using serology assays performed on day 28 after the second dose and up to one year after the first dose
    - to assess in depth the humoral and cellular responses to the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech), by measuring the Sars-Cov2 specific T and B cell responses and its evolution and longevity by sampling blood at different time point
    - To compare the immunogenicity and safety of vaccination in patients previously infected or not by SARS-Cov2
    - To assess the safety and the efficacy of a third dose of vaccination in COVID19-free patients
    - To assess the immune reponse to additional dose of anti-SARS-CoV2 vaccination
    - To assess the immune response to new variants in breakthrough cases
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age of 18 years old or older
    - Patients should met one of the cohort criteria
    - life expectancy > 12 months
    - Ability to provide informed consent
    E.4Principal exclusion criteria
    - women who are pregnant or breastfeeding

    To reflect the real-world population of hemodialysis patients, the NEPHRO-VAChemodialysis project is designed as inclusive as possible. Exclusion criteria are minimal and serve to exclude patients who are not evaluable, or in whom vaccination is considered not safe or not effective.
    Since baseline blood samples before vaccination will provide an individual reference level of antibody measures, potential bias can be anticipated for. As such, we can still evaluate the immune response induced by the vaccination only. Moreover, At baseline (ie before vaccination) blood samples will be taken. The existence of SARS-Cov-2 antibodies will be examined in the samples in retrospect. As such, based on the baseline antibody levels, we can divide the study population in a COVID+ and COVID- subgroup and perform subgroup analysis to evaluate the effect of this variable. We feel it is not feasible and necessary to exclude patients for the trial based on prevaccination SARS-CoV-2 antibody positivity. First of all the procedures in the study reflect the real life situation. Secondly, analyzing the study results the revaccination antibody levels will be a variable used in the analysis.
    E.5 End points
    E.5.1Primary end point(s)
    ELISA RBD antibodies (IgG) 28 days after booster dose. For those with a previous COVID infection, the in house multiplex assay from Sciensano will be performed to discriminate between previous infection and vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28 after second vaccination
    E.5.2Secondary end point(s)
    - Safety is accurately followed in hemodialysis patients receiving a vaccine through an autoquestionnary. Patients receive an individual planning for their study visits to the hospital among which also vaccination days are planned. Of course patients are planned to get a vaccine during a study consult on a day also other patients will receive their vaccine. A maximum of 24 patients will receive a vaccination per day. Next to the study nurse, also a doctor will be present for patient monitoring. After the consult, any adverse events, including redness at the injection site, will be followed continuously during each medical visit. It will be noticed each “Adverse event (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)” and if there is a suspected relationship between AE and vaccin. Each suSAR will be reported in the SAE-form in the attached document.
    - ELISA RBD antibodies (IgG) 7 days after booster dose, titer of neutralizing antibodies 7 and 28 days after booster dose.
    Both total and neutralizing antibodies against SARS-Cov-2 will be assessed. The total amount of anti- SARS-Cov-2 IgG antibodies will be studied using an ELISA in which the binding capacities against SARS-CoV-2 spike protein – full S (S1 and S2) as well as against the receptor-binding domain of SARS-CoV-2 protein are tested. Furthermore, a multiplex immune assay will be used for simultaneously testing of the presence of different SARS-CoV-2 binding IgG antibodies. To measure the titers of neutralizing antibodies against SARS-Cov-2 spike protein and nucleocapsid protein, the capacity of the antibodies to neutralize an infection with SARSCoV-2 or pseudoviral particles in vitro will be tested. These methodologies are established and available at the laboratory of Sciensano.
    Both simple and multi parametric analyses will be performed. The aim is to have these answers within the first month after day 28 of the boost.
    - Additional endpoints: B-cell immunity seven days after booster dose, measuring memory B cells. T-cell immunity 28 days after boost.
    - After additional dose: humoral and cellular responses will be analyzed at two supplementary timepoints: just before the additional dose and 28 days after additional dose.
    - In case of breakthrough case: a blood sample during the 5 first days of symptomes and at day 21, in addition to a nasopharyngeal swab with PCR is planned, for humoral response assessment.

    Measurements of the geometric mean concentrations will be calculated for the SARS-CoV-2 specific IgG antibodies. If a serological correlate of protection for COVID-19 based IgG antibody levels (in IU/mL) will be known before data analysis the definition of a responder will be based on having serum concentration of IgG antibodies on day 28 after second vaccination above this cut-off. If no cut-off is established at time of data analysis, we will use a seroconversion (a ≥ 4-fold increase of the geometric mean concentration (GMC) of SARS-CoV-2 specific IgG antibodies over baseline). Titers will be expressed as GMCs with 95% CIs for each cohort, for each time point. Patients will be classified as responders or non-responders.
    As mentioned in the protocol, the statistical analysis is indeed descriptive. This means that the data resulting from the NEPHRO-VAC will be summarized in an organized manner by describing the immune response in a population of cancer patients. Box plots will be used for interpreting descriptive data in graphical form. This is a vital first step before making inferential statistical comparisons between different cohorts. This will include estimates of variance and comparisons between the different patient cohorts. The most robust appropriate statistical tests will be applied. Full transparency about the analysis and presentation of all individual data points will be available.
    All analyses will be performed in R (R Core Team (2018), available from https://www.R-project.org/), STATA or SAS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 28, day 49, day 180 and day 365 (end of the study) AND the day of the third dose, 7, 28 AND before an additional dose and 28 days after an additional dose.
    In case of breakthrough case: during the first 5 days of symptoms and at day 21
    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 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 concerned2
    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 months
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state120
    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 Decision2021-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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