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    Summary
    EudraCT Number:2021-000842-16
    Sponsor's Protocol Code Number:PIRVACoV
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-18
    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 number2021-000842-16
    A.3Full title of the trial
    Does PFAS-exposure modify the risk of COVID-19 infection or the immunological response after vaccination against SARS-CoV-2?
    Modifierar PFAS-exponering risk för COVID-19 eller immunologiskt svar efter vaccination mot SARS-CoV-2?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of Perfluoroalkyl substances on SARS-CoV-2 vaccination.
    Effekterna av Perfluorerade alkylsyror på SARS-CoV-2-vaccination.
    A.4.1Sponsor's protocol code numberPIRVACoV
    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 SponsorKristina Jakobsson
    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 supportSwedish Research Council for Health, Working Life and Welfare (FORTE)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Gothenburg
    B.5.2Functional name of contact pointKristina Jakobsson
    B.5.3 Address:
    B.5.3.1Street AddressMedicinaregatan 16A
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code405 30
    B.5.3.4CountrySweden
    B.5.4Telephone number+46031786 6256
    B.5.6E-mailKristina.jakobsson@amm.gu.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.2.1.2Country 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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    An observational study in healthy, differently PFAS-exposed subjects to check if PFAS modifies the immunological response to SARS-CoV-2 vaccination. The immunological response is quantified as SARS-CoV-2-specific IgG antibody production and T-cell activity.
    En observationsstudie i friska, olikt PFAS-exponerade personer för att se om PFAS modifierar den immunologiska response till SARS-CoV-2 vaccination. Den immunologiska response är kvantifierad som SARS-CoV-2-specifik IgG-antikroppsproduktion och T-cellsaktivitet.
    E.1.1.1Medical condition in easily understood language
    An observational study in healthy subjects with different exposure to Perfluoroalkyl substances (PFAS). The aim is to see if PFAS affects immune response after SARS-CoV-2 vaccination.
    En observationsstudie i friska deltagare med olika exponeringar för Perfluorerade Alkylsubstanser (PFAS). Syftet är att se om PFAS påverkar immunsvaret efter SARS-CoV-2-vaccination.
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084462
    E.1.2Term SARS-CoV-2 vaccination
    E.1.2System Organ Class 100000004865
    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
    The overarching aim is to gather knowledge about how Perfluoroalkyl substances (PFAS) affects the immune system. This aim is studied through immunological response after SARS-CoV-2-vaccination in adults.

    Primary research question: Does PFAS-exposure modify IgG-antibody production after SARS-CoV-2-vaccination?

    The question will be answered through quantification of IgG-antibodies against SARS-CoV-2 S-protein. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high.
    Det övergripande syftet är att få ökad kunskap om hur PFAS påverkar immunsystemet. Specifikt studeras det immunologiska svaret vid vaccination mot SARS-CoV-2 bland vuxna.

    Primär frågeställning: Påverkar PFAS-exponering IgG-antikroppssvaret efter vaccination mot SARS-CoV-2?

    Utfallsmått: IgG mot SARS-CoV-2 S protein. Exponeringsmått: Summan av 16 PFAS-ämnen i serum, kategoriserad som antingen låg eller hög.
    E.2.2Secondary objectives of the trial
    Secondary research question: Does PFAS-exposure affects the cellular immune response after SARS-CoV-2-vaccination?

    This question will be answered through analyses of SARS-CoV-2 specific T-cell response. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high.
    Sekundär frågeställning: Påverkar PFAS-exponering det cellulära immunsvaret mot SARS-CoV-2 S protein efter vaccination mot SARS-CoV-2?

    Utfallsmått: För T-celler bestäms SARS-CoV-2 specifika T-cellssvar. Exponeringsmått: Summan av 16 PFAS-ämnen i serum, kategoriserad som antingen låg eller hög.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women, 20 to 60 years old, who participated in PFAS-studies 2014-2016 with measured serum PFAS-levels, planning to be vaccinated against SARS-CoV-2.
    Män och kvinnor, 20 till 60 år gamla, som deltog I PFAS-studierna 2014-2016 med mätt serum-PFAS-nivåer och som planerar att bli vaccinerad mot SARS-CoV-2.
    E.4Principal exclusion criteria
    Previous vaccination against SARS-CoV-2
    Tidigare vaccinering mot SARS-CoV-2
    E.5 End points
    E.5.1Primary end point(s)
    IgG-antibodies against S-protein from SARS-CoV-2
    IgG-antikroppar mot S-protein från SARS-CoV-2
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 6 and 24 months after full vaccination.
    1, 6 och 24 månader efter full vaccination.
    E.5.2Secondary end point(s)
    T-cell response against S-protein from SARS-CoV-2
    T-cellssvar mot S-protein från SARS-CoV-2
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 6 and 24 months after full vaccination.
    1, 6 och 24 månader efter full 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 No
    E.6.4Safety No
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 500
    F.1.3Elderly (>=65 years) No
    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 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 2021-02-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state500
    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
    Inga
    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 Decision2021-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
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