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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   42869   clinical trials with a EudraCT protocol, of which   7063   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2021-001070-38
    Sponsor's Protocol Code Number:B-pVAC-SARS-CoV-2
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2021-03-24
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-001070-38
    A.3Full title of the trial
    B-pVAC-SARS-CoV-2: Phase I/II multi-center safety and immungenicity trial of multi-peptide vaccination to prevent COVID-19 infection in adults with B-cell/antibody deficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    B-pVAC-SARS-CoV-2: Phase I/II multi-center safety and immungenicity trial of multi-peptide vaccination to prevent COVID-19 infection in adults with B-cell/antibody deficiency
    A.4.1Sponsor's protocol code numberB-pVAC-SARS-CoV-2
    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 SponsorUniversity Hospital Tuebingen
    B.1.3.4CountryGermany
    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 supportUniversity Hospital Tuebingen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZentrum fuer Klinische Studien
    B.5.2Functional name of contact pointZentrum fuer Klinische Studien
    B.5.3 Address:
    B.5.3.1Street AddressFrondsbergstrasse 23
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)70712985434
    B.5.5Fax number+49(0)70712925080
    B.5.6E-mailzks-pm@med.uni-tuebingen.de
    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 No
    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 nameMultipeptide vaccine + XS15
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    Adults with congenital or acquired B cell/antibody deficiency
    E.1.1.1Medical condition in easily understood language
    Adults with congenital or acquired B cell/antibody deficiency
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I:
    The primary objective of phase I of this trial is to evaluate the safety and tolerability of CoVac-1 in adults with congenital or acquired B cell/antibody deficiency.

    Phase II:
    The primary objective of phase II of this trial is to evaluate the efficacy of the CoVac-1 vaccine in terms of induction of SARS-CoV-2 specific T cells.
    E.2.2Secondary objectives of the trial
    Phase I:
    The secondary objective of phase I of this trial is to
    evaluate the efficacy of the CoVac-1 vaccine. In
    addition, humoral immune responses will be assessed.

    Phase II:
    The secondary objectives of phase II of this trial are to
    evaluate the safety and tolerability of CoVac-1. In
    addition, humoral immune responses will be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult (≥18 years) male or non-pregnant, non-lactating
    female
    2. Primary antibody deficiency syndrome or Secondary
    antibody deficiency syndrome, defined by one of the
    following:
    - IgG < 5.5 g/l
    - Ongoing substitution of immunoglobline for
    hypogammaglobinemia
    - Anti-CD20 antibody (monospecific) therapy for
    malignant disease:
     after combined Anti-CD20 antibody
    therapy with chemotherapy (e.g.
    fludarabin, cyclophosphamid,
    bendamustin, anthracycline, vincristin)
    (within 1-6 months post therapy)
     ongoing or up to 6 months after single
    agent Anti-CD20 antibody therapy
     ongoing or up to 6 months after combined
    Anti-CD20 antibody therapy with BTKinhibitors
    or BCL2-inhibitors
     Anti-CD20 antibody maintenance therapy
    3. Ability to understand and voluntarily sign an informed
    consent form
    4. Ability to adhere to the study visit schedule and other
    protocol requirements
    5. Female patients of child bearing potential (FCBP) and
    male patients with partners of child bearing potential, who
    are sexually active, must agree to the use of two effective
    forms (at least one highly effective method) of
    contraception. This should be started from the signing of
    the informed consent and continue until three months
    after vaccination. Furthermore, contraception must be
    carried on by patients receiving B-cell depleting therapies
    for the whole duration of the treatment.
    6. Postmenopausal or evidence of non-child-bearing
    status. For women of childbearing potential: negative
    urine or serum pregnancy test within 7 days prior to study
    treatment. Postmenopausal or evidence of nonchildbearing
    status is defined as:
    - Amenorrhoea for 1 year or more following
    cessation of exogenous hormonal treatments
    - Luteinizing hormone (LH) and Follicle stimulating
    hormone (FSH) levels in the postmenopausal
    range for women under 50
    E.4Principal exclusion criteria
    1. Pregnant or lactating females

    2. Participation in any clinical trial with intake of any investigational or non-registered vaccine product

    3. Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint:
    - Active infection
    - Psychiatric disorders
    - Known systemic anaphylaxis


    4. Prior or current infection with SARS-CoV-2 as assessed by medical history, or by throat/nose swab (PCR) or
    serologically documented immunization against SARS-CoV-2 (after infection or vaccination)
    5. persisting symptoms developed after vaccination against SARS-CoV-2 with one of the approved vaccines-products

    6. HIV infection, chronic or active hepatitis B or C

    7. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/haemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child)

    8. Baseline laboratory CD4+ T cell count < 100 µl

    9. The following pre-existing medical conditions:
    - Chronic liver failure defined as Child-Pugh Score ≥B
    - Chronic renal failure defined as GFR <40 ml/min/1,73m2
    - Serious pre-existing cardiovascular disease such as NYHA ≥ III
    - Sickle cell anemia

    10. Known hypersensitivity to any of the components included in the CoVac-1 vaccine

    11. Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis

    12. Patient receiving active treatment with Proteosome- Inhibitors (e.g. Bortezomib), Phosphoinositid-3-Kinase-Inhibors (e.g. Idelalisib)
    13. Patient receiving active treatment with small molecules, including Tyrosine Kinases-Inhibitors (e.g. Ibrutinib),
    Proteosome-Inhibitors (e.g. Bortezomib), Bcl-2-Inhibitors (Venetoclax) or Phosphoinositid-3-Kinase-Inhibors (e.g. Idelalisib)
    14. Intention of receiving one dose of an already approved vaccine against SARS-CoV-2 before day 56
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    Based on the primary objective the primary endpoint is defined as:
    • The nature, frequency, and severity of AEs and/or SAEs associated with CoVAC-1:
    - Solicited: ADRs/AEs occurring from the time of each injection throughout V4 days following the procedure, facilitated by use of a patient diary
    - Unsolicited: AEs from the time of injection throughout V5 following injection
    - SAEs from the time of injection until the final study visit for each subject
    - Incidence of AESIs until the final study visit for each subject
    Phase II:
    Based on the primary objective the primary endpoint is defined as:
    • Development of a CoVac-1 specific T cell response to at least one of the single SARS-CoV-2 T cell epitopes included in the CoVac-1 vaccine in > 80% of the patients until V4 measured by IFN-γ ELISpot ex vivo and after in vitro T cell amplification (compared to Visit 1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 98, Month 5 and 8 after peptide vaccination
    E.5.2Secondary end point(s)
    Phase I
     Cellular immunity: Development of a CoVac-1 specific T cell response to at least one of the single SARS-CoV-2 T cell
    epitopes included in the CoVac-1 vaccine on Visits 2, 3, 4, 5, 6 measured by IFN-γ
    ELISpot ex vivo and after in vitro T cell amplification (compared to Visit 1), this includes:
     Cellular conversion rate (CCR) at Visits 2, 3, 4, 5, 6 after immunization
     Assessment of humoral immune response: Development of SARS-CoV-2 specific antibodies at Visits 2, 3, 4, 5, 6 after immunization (measured by Siemens sCOVG Assay at the Central Laboratory of the
    University Hospital Tubingen).
    Phase II
    - Solicited: ADRs/AEs occurring from the time of each injection throughout V4
    following the procedure, facilitated by use of a patient diary
    - Unsolicited: AEs from the time of injection throughout V5 following injection
    - SAEs from the time of injection until the final study visit for each subject
    - Incidence of AESIs until the final study visit for each subject
     Assessment of humoral immune response: Development of SARS-CoV-2 specific antibodies at Visits 2, 3, 4, 5, 6 after immunization (measured by Siemens sCOVG Assay at the Central Laboratory of the
    University Hospital Tubingen).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 98, Month 5 and 8 after peptide vaccination
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.2.4Number of treatment arms in the trial1
    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
    The end of Study for a subject enrolled in this trial is defined as the last study visit.
    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 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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state60
    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)
    not applicable
    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 Decision2021-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-21
    P. End of Trial
    P.End of Trial StatusRestarted
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