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    Summary
    EudraCT Number:2021-000683-30
    Sponsor's Protocol Code Number:CoVacc
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-23
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-000683-30
    A.3Full title of the trial
    CoVacc - Immune response to vaccination against Covid-19, an open multicenter phase IV study
    CoVacc - Immunsvar vid vaccination mot Covid-19, en öppen multicenter fas IV studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CoVacc - Immune response to vaccination against Covid-19
    A.4.1Sponsor's protocol code numberCoVacc
    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 SponsorUmeå university
    B.1.3.4CountrySweden
    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 supportUmeå University
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportScience for Life Laboratory
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmeå university
    B.5.2Functional name of contact pointClas Ahlm
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Clinical Microbiology, University hospital
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code90185
    B.5.3.4CountrySweden
    B.5.6E-mailclas.ahlm@umu.se
    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 Covid-19 vaccine, all vaccines with marketing authorisation in Sweden are allowed.
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameCovid-19 vaccine
    D.3.2Product code NA
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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
    Individuals with and without pre-existing immunity to Covid-19.
    Individer med och utan existerande immunitet mot Covid-19.
    E.1.1.1Medical condition in easily understood language
    Individuals with and without previous Covid-19 disease.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does antibody development to SARS-CoV-2 S protein differ after vaccination between those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals?
    Skiljer sig antikroppsutveckling mot SARS-CoV-2 S-protein efter vaccination mellan de som haft tidigare SARS-CoV-2-infektion jämfört med Covid-19 naiva individer?
    E.2.2Secondary objectives of the trial
    Better understanding of how the human immune system reacts when exposed to foreign protein antigen measured as antibody level in serum, plasma and mucosa as well as at the cellular and genetic level.
    The secondary issues are those that are general to understanding how the human immune system works in both infection and vaccination.
    Att bättre förstå hur det mänskliga immunförsvaret reagerar när det blir exponerat för främmande proteinantigen mätt som antikroppsnivå i serum, plasma och slemhinna samt på cellullär och genetisk nivå.
    De sekundära frågeställningarna är sådana som är generella för att förstå hur det mänskliga immunförsvaret fungerar vid både infektion och vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Consents to participate in the study
    • Age ≥ 18 years
    • Samtycker till deltagande i studien
    • Ålder≥ 18 år
    E.4Principal exclusion criteria
    • Age <18 years
    • Incapable of giving informed consent (does not apply to participants in the elderly study)
    • Contraindication to vaccination
    • Severe disease (assessed to affect the subjects ability to complete the study)
    • Ongoing treatment that is judged to affect the vaccine response (Does not include inhaled steroids and nasal sprays, as well as tablet cortisone ≤15mg / day. Rituximab treatment is not an exclusion criterion.)
    Participants in the elderly study:
    The exclusion criteria described in the protocol above for CoVacc will not apply to the sub-study called The Elderly Study, this clinical research study in which people with severe illness and people who lack their own decision-making ability can be included. Data on chronic diseases or drugs will not be collected
    • Ålder <18 år
    • Beslutsoförmögna personer (gäller ej deltagare i äldrestudien)
    • Kontraindikation till vaccination
    • Svår sjukdom (som bedöms påverka forskningspersonens möjlighet att fullfölja studien)
    • Pågående läkemedelsbehandling som bedömes påverka vaccinsvaret (innefattar inte inhalationssteroider och nässpray, samt tablett kortison ≤15mg/dag. Rituximab behandling är ej ett exklusionskriterie)
    Deltagare i äldrestudien:
    De exklusionskriterier som är beskrivna i protokollet ovan för CoVacc kommer inte att gälla den delstudie som benämns Äldrestudien, denna kliniska forskningsstudie där personer med svår sjukdom och personer som saknar egen beslutsförmåga kan inkluderas. Uppgifter om kroniska sjukdomar eller läkemedel kommer inte att insamlas.

    E.5 End points
    E.5.1Primary end point(s)
    Investigate the level of specific antibodies to SARS-CoV-2 yearly, up to four years after vaccination.
    Undersöka nivån av specifika antikroppar mot SARS-CoV-2 årligen, upp till fyra år efter vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4 year after vaccination
    1, 2, 3, 4 år efter vaccination.
    E.5.2Secondary end point(s)
    Analyzes to investigate how the human immune system reacts to Covid 19 vaccine.
    Analyser för att utreda hur det mänskliga immunförsvaret reagerar vid Covid 19-vaccin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before and after each dose of vaccine. Thereafter the following times after vaccination: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years and 4 years.
    Före och efter varje dos av vaccin. Därefter följande tidpunkter efter vaccination: 1 månad, 3 månader, 6 månader, 1 år, 2 år, 3 år samt 4 år.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 concerned5
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 2250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 2021-02-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants in the elderly study:
    The Elderly Study, this clinical research study in which people with severe illness and people who lack their own decision-making ability can be included.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3000
    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 Decision2021-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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