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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.
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    Summary
    EudraCT Number:2020-002502-75
    Sponsor's Protocol Code Number:P-pVAC-SARS-CoV-2
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-26
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-002502-75
    A.3Full title of the trial
    P-pVAC-SARS-CoV-2: Phase I single-center safety and immungenicity trial of multi-peptide vaccination to prevent COVID-19 infection in adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Covid-19 Vaccination Trial
    A.4.1Sponsor's protocol code numberP-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 organisationUniversity Hospital Tuebingen
    B.5.2Functional name of contact pointZenrtum fuer Klinische Studien
    B.5.3 Address:
    B.5.3.1Street AddressFrondsbergstrasse 23
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72070
    B.5.3.4CountryGermany
    B.5.4Telephone number4970712985635
    B.5.5Fax number4970712925080
    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 nameMulti Peptide Vaccine + XS 15
    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
    healthy subjects obtaining a potential vaccine for COVID-19
    E.1.1.1Medical condition in easily understood language
    Vaccine for COVID-19
    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
    To evaluate the safety and immunogenicity of a single use of a SARS-CoV-2 specific multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in adults

    The primary objective of this trial is to evaluate the safety and tolerability of the CoVac-1 vaccine, a single dose SARS-CoV-2 specific multi-peptide vaccine combined with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG in adults.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this trial are to evaluate the efficacy (immunogenicity), overall safety, SARS-CoV-2 infection rate and course of COVID-19 disease upon application of the CoVac-1 vaccine, a single dose SARS-CoV-2 specific multi-peptide vaccine combinedwith the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male or non-pregnant, non-lactating female
    1. Part I: Age 18-55 at the time of screening
    2. Part II: Age 56-80 years at the time of
    screening
    2. Pre-existing medical condition
    1. Part I : Free of clinically significant health
    problems, as determined by pertinent medical
    history and clinical examination at study
    screening
    2. Part II: With or without pre-existing medical
    condition, not requiring change in therapy or
    hospitalization before enrollment
    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 volunteers of child bearing potential (FCBP)
    and male volunteers 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
    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:
    1. Amenorrhoea for 1 year or more following
    cessation of exogenous hormonal treatments
    2. Luteinizing hormone (LH) and Follicle stimulating
    hormone (FSH) levels in the postmenopausal
    range for women under 50
    7. Be willing to minimize blood and body fluid exposure
    from others for 7 days after vaccination
    1. Use of effective barrier prophylaxis, such as latex
    condoms, during sexual intercourse
    2. Avoiding the sharing of needles, razors, or
    toothbrushes
    3. Avoiding open-mouth kissing
    8. Refrain from blood donation during the course of the
    study
    E.4Principal exclusion criteria
    1. Pregnant or lactating females.
    2. Participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint
    3. Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint
    4. Any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day)
    5. Serological evidence of prior SARS-CoV-2 infection prior to vaccination
    6. Prior or current infection with SARS-CoV-2 tested serologically or by throat/nose swab (PCR)
    7. History of Guillain-Barré Syndrome
    8. Positive serological HIV, hepatitis B and C test. In case of positive HBsAg volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
    9. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child)
    10. Baseline laboratory with lymphocyte count ≤ 1000/µl
    11. Only Part I: Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test
    12. Hospitalization at study inclusion
    13. Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
    14. History of blood donation within 30 days of enrollment or plans to donate within the study period
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of critical events (any (S)AE ≥ 4) associated with administration of CoVac-1 until Visit 4 (V4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1,2,3,4
    E.5.2Secondary end point(s)
    • The nature, frequency, and severity of AEs and/or SAEs associated with administration of CoVac-1 until V5.
    • Solicited: AEs occurring from the time of injection throughout 28 days following the procedure, facilitated by use of a volunteer diary
    • Unsolicited: AEs from the time of injection throughout 56 days following injection
    • SAEs from the time of injection unit the final study visit for each subject
    • Incidence of AESIs until V5
    • Development of a CoVac-1 specific T cell response and IgG antibodies (≥2-fold increase) on Visits 2, 3, 4 and 5 measured by ELISpot and ELISA, respectively as compared to baseline (V1)
    • Infection rate up to 28 days after vaccination
    • if applicable:
     Hospitalization rate after infection
     Duration of hospitalization
     Proportion admitted to ICU
     Proportion requiring invasive ventilation
     COVID-19 related mortality within 2 month
    • Quality of life from baseline until end of safety follow-up as assessed by EORTC (QLQ-C30)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The nature, frequency, and severity of AEs and/or SAEs associated with administration of CoVac-1 V1-V5.
    • Solicited: through out 28 days following the procedure
    • Unsolicited: throughout 56 days following injection
    • SAEs from the time of injection unit the final study visit
    • Incidence of AESIs until V1- V5
    • specific T cell response and IgG antibodies on Visits 2, 3, 4 and 5 respectively as compared to baseline (V1)
    • Infection rate up to 28 days after vaccination
    • if applicable:
     Hospitalization rate after infection
     Duration of hospitalization
     Proportion admitted to ICU
     Proportion requiring invasive ventilation
     COVID-19 related mortality within 2 month
    • Quality of life from baseline until end of safety follow-up
    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 trial32
    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 the study is defined as the last visit of the last volunteer.
    See Protocol Section Ch.6.6 to 6.10
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 No
    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 state32
    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 Decision2020-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-21
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