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    Summary
    EudraCT Number:2021-002363-22
    Sponsor's Protocol Code Number:IIV-482
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-002363-22
    A.3Full title of the trial
    Vaccination of older persons against Sars-Cov-2 and cellular immunogenicity for long term protection
    (participating in the Doetinchem Cohort Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination of older persons against SARS-CoV2 and inducing cellular immunity
    A.3.2Name or abbreviated title of the trial where available
    VOCAAL
    A.4.1Sponsor's protocol code numberIIV-482
    A.5.4Other Identifiers
    Name:ABR numberNumber:NL76719.041.21
    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 SponsorNational Institute for Public Health and the Environment
    B.1.3.4CountryNetherlands
    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 supportNational Institute for Public Health and the Environment
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute for Public Health and the Environment
    B.5.2Functional name of contact pointInge Pronk
    B.5.3 Address:
    B.5.3.1Street AddressAntonie van leeuwenhoeklaan, 9
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3701 MA
    B.5.3.4CountryNetherlands
    B.5.6E-mailvocaal@rivm.nl
    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 AuthorisationNetherlands
    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.3.11 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    SARS-CoV-19, frailty
    E.1.1.1Medical condition in easily understood language
    COVID-19, frailty
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Assess the magnitude of systemic antibody responses to the SARS-CoV-2 vaccine in 64-90 years old male and female persons at a month after completion of SARS-CoV-2 vaccination.
    • To address the magnitude and quality of T-cell and B-cell immune responses induced by the current new SARS-CoV-2 vaccines at a month after completion of SARS-CoV-2 vaccination in older male and female persons (64-90 years of age).

    E.2.2Secondary objectives of the trial
    • Monitoring of kinetics and longevity of antibody and cellular responses induced by SARS-CoV-2 vaccination.
    • Measuring vaccine-induced antibody capacity for (pseudo)neutralization of circulating SARS-CoV-2 subvariants, either dominant genotype or future mutations.
    • Measuring the (IgA and IgG) antibody response in the nasal mucosal lining fluid and/or saliva, induced by SARS-CoV-2 vaccines.
    • Assess possible interference of infection with SARS-CoV-2 with antibody responses and B end Tcell responsiveness as well , by measuring virus-specific serum IgG antibodies to SARS-CoV-2 Core N protein and using data on the results of PCR testing and from questionnaires.
    • Assess the relation of age and frailty index of older male and female persons with all immune responses to SARS-CoV-2.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Having participated the ISA study (part of the DCS).
    • Willing to receive the SARS-CoV-2 vaccine.
    • Willing to give the Informed Consent.
    E.4Principal exclusion criteria
    A potential subject will be excluded from participation in this study when a person already received the last SARS-CoV-2 vaccination more than a month earlier and has not signed the ICF at T0, T1 or T2 .
    E.5 End points
    E.5.1Primary end point(s)
    • Specific serum IgG antibody concentrations at one month after the second vaccination. Serum samples will be tested for the presence and concentration of SARS-CoV-2 specific antibodies by quantitative multiplex serology (21).
    • Frequencies of of the adaptive memory B-cell responses and functional T-cell responses at one month after the second SARS-CoV-2 vaccination will be measured.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month post last vaccination.
    E.5.2Secondary end point(s)
    1 Longevity of antibody levels and cellular responses as described above will be determined at 1 year post vaccination (T4)
    2 IgG antibody titers to other coronaviruses will be measured by bead-based multiplex immuno assay at T0, T3 and T4.
    3 Selected SARS-CoV-2 positive serum samples will be tested for antibody binding strength (avidity) and virus neutralization, providing a functional measure of immune protection at 1 month (T1) (T2), 6 months (T3) and 1 year (T4) post vaccination
    4 Mucosal IgA and IgG antibodies will be determined in nose fluids or saliva by bead-based multiplex immuno assay at T2 and T4.
    5 IgG antibodies to the SARS-CoV-2 core N protein indicating contact with the virus will be determined by the MIA assay as described
    6 Self-reported experiences possible SARS-CoV-2 infection from answers to a short questionnaires.
    7 Integrated endpoint analysis of all antibody analysis with age, sex and frailty data.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.1 year after last vaccination
    2. pre and 6 and 12 months post last vaccination.
    3. 1 month after first vaccination, 6 and 12 months post last vaccination.
    4. 1 month an 1 year post last 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 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
    Immune response to SARS-CoV-2 vaccines.
    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 No
    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 years1
    E.8.9.1In the Member State concerned months6
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state150
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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