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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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:2021-001040-10
    Sponsor's Protocol Code Number:CoVVac
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-26
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-001040-10
    A.3Full title of the trial
    Humoral and cellular immune response to COVID-19 vaccines in immunocompromised and healthy individuals – The CoVVac study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Humoral (antibodies) and cellular (white blood cells) immune response to COVID-19 vaccines in immunocompromised (people with impaired immune system) and healthy individuals – The CoVVac study
    A.3.2Name or abbreviated title of the trial where available
    The CoVVac study
    A.4.1Sponsor's protocol code numberCoVVac
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    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 supportMedical University of Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 2
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.6E-mailmartin.stradner@medunigraz.at
    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 concentrate for dispersion for injection
    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.3.4Pharmaceutical form Concentrate for solution 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 INNCOVID-19 mRNA Vaccine
    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) 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 dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    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.3.4Pharmaceutical form Concentrate for solution 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 INNCOVID-19 mRNA Vaccine
    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 microgram(s)
    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.IMP: 3
    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 Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S [recombinant])
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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.3.4Pharmaceutical form Suspension 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 INNCOVID-19 Vaccine
    D.3.9.3Other descriptive nameCOVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    D.3.9.4EV Substance CodeSUB207764
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.5E8
    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
    Active immunisation to prevent COVID-19 in immunocompromised individuals.
    E.1.1.1Medical condition in easily understood language
    Active immunisation to prevent coronavirus disease 2019 in individuals with weak immune system.
    E.1.1.2Therapeutic area Health Care [N] - Population Characteristics [N01]
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Characterization of the anti-SARS-CoV-2 humoral immune response after vaccination with a focus on the anti-spike protein response: an analysis in immunocompromised patients compared to healthy controls.
    E.2.2Secondary objectives of the trial
    Compare T cell response of healthy & immunodeficient subject
    Differnce in seroconversion or T cell response between different vaccines
    Impact of immune system´s aging to humoral & cellular immune response
    Impact of the various forms of immunosuppression on the vaccine-induced response
    Impact of previous SARS-CoV-2 infection and
    Role of previous asymptomatic SARS-CoV-2 infection on the vaccine induced response
    Compare immune response of the various vaccines & participants
    Difference in the induction of secretory IgA and serum IgA in comparison to the serum IgG and IgM response
    Influence of previous infections caused by endemic CoV on the vaccine response
    Difference in the induction of neutralizing antibodies in subsets of immunocompromised & in COVID-19 recovered individuals compared to COVID-19 naïve controls
    Difference in the neutralizing capacity of antibodies after vaccination towards the emerging SARS-CoV-2 variants
    Humoral & cellular effect of a booster vaccination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet one of the following inclusion criteria:
    1. Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
    or
    2. Patients with primary immunodeficiencies
    or
    3. Patients with B-cell depleting therapy due autoimmune disease
    or
    4. Patients with benign and malignant hematological diseases receiving specific treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies.
    or
    5. Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment.
    or
    6. Patients >3 months but <12 months after autologous HSCT.
    or
    7. Patients >3 months but <12 months after allogeneic HSCT.
    or
    8. Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy.
    or
    9. Patients with chronic GvHD and persistent immunodeficiency.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria cannot be enrolled into the trial:

    Healthy participants
    1. Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.
    2. Presence of a disease requiring change in therapy during 4 weeks before enrollment.
    3. Any contraindications to the vaccine planned to receive as listed in the product characteristics.
    4. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
    5. Women who are pregnant or breastfeeding.
    6. Previous vaccination with any coronavirus vaccine.
    7. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).

    Immunodeficient participants
    1. Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells).
    2. Patients with hematological malignancies in remission and >12 months after end of specific therapy.
    3. Patients within three months from HSCT.
    4. Any contraindications to the vaccine planned to receive as listed in the product characteristics.
    5. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
    6. Women who are pregnant or breastfeeding.
    7. Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank).
    8. Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
    E.5 End points
    E.5.1Primary end point(s)
    The seroconversion leading to anti-SARS-CoV-2 spike protein humoral immune response at day 21-28 after the second vaccination measured by SARS-CoV-2 antigen-binding Ig assay, comparing immunocompromised patients to healthy controls.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 21-28 after the second vaccination.
    E.5.2Secondary end point(s)
    • Seroconversion measured by SARS-CoV-2 antigen-binding Ig assay 6 and 12 months after second, 3-5 weeks and 6 months after third vaccination
    • Concentrations of recombinant S protein-binding IgG depending on prior exposure to SARS-CoV-2.
    • Concentrations of secretory and serum IgA in comparison to IgG and IgM after second and third vaccination in immunocompromised, in recovered individuals and in healthy controls.
    • Cytokine production of T cells after SARS-CoV-2 antigen exposure, measured by FACS and ELISpot
    • Identification of parameters predicting the response to COVID-19 vaccinations: prior CoV infection (cross-reactive antibodies), quantitative immunoglobulins, B cell subsets, T cell subsets; T cell aging (TCR diversity, telomere length, TREC levels)
    • Neutralizing capacity of antibodies in respect of different SARS-CoV-2 variants
    • Correlation of dietary inflammation index and subcutaneous fat thickness sum with seroconversion after second vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After second and third vaccination and 6 and months after vaccination, respectively.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Characterization of the anti-SARS-CoV-2 humoral immune response after vaccination with a focus on the anti-spike protein response: an analysis in immunocompromised patients compared to healthy controls.
    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 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 years
    E.8.9.1In the Member State concerned months26
    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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 195
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-03-26. Yes
    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 state390
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-20
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