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    Summary
    EudraCT Number:2021-003573-58
    Sponsor's Protocol Code Number:2025
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-16
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-003573-58
    A.3Full title of the trial
    Vaccination against cOvid-19 In CancEr: booster shot BNT161b2 vaccine after full vaccination with ChAdOx1-S vaccine (Tri-VOICE plus)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Using one dose Pfizer to boost immunity after full vaccination with AstraZeneca in cancer patients
    A.3.2Name or abbreviated title of the trial where available
    Tri-VOICE plus
    A.4.1Sponsor's protocol code number2025
    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 SponsorAntwerp University Hospital
    B.1.3.4CountryBelgium
    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 supportfederal governance
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntwerp University Hospital
    B.5.2Functional name of contact pointdata manager
    B.5.3 Address:
    B.5.3.1Street AddressDrie Eikenstraat 655
    B.5.3.2Town/ cityEdegem
    B.5.3.3Post codeB2650
    B.5.3.4CountryBelgium
    B.5.6E-maillise.verbruggen@uza.be
    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 Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCOMIRNATY
    D.3.4Pharmaceutical form Dispersion 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) 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
    Onco-hematological patients
    E.1.1.1Medical condition in easily understood language
    Onco-hematological patients
    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
    In the Tri-VOICE plus project, we want to offer a BNT161b2 vaccine booster shot as third and fourth dose with priority in a cohort of cancer patients being fully vaccinated with the ChAd-Ox1-S vaccine. In this way, we provide an answer to the high probability that these patients are left unprotected. On top of that, collecting knowledge about mixing vaccines and administering a booster shot is in line with the current clinical trials.
    E.2.2Secondary objectives of the trial
    •To investigate the safety of the third and fourth dose of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®)
    •To investigate the kinetics and longevity of the antibody response after third and fourth dose
    •To investigate the proportion of high-responders per current treatment cohort from the day of receiving an additional shot of BNT162b2 vaccine and 28 days thereafter.
    •To analyze the IgG titer of neutralizing antibodies, only in cases lower limit of quantification for the detection of binding antibodies is exceeded, at all the different timepoints
    •Assessment of the cellular immune response
    •Assessment of the SARS-Cov2 breakthrough infection rate
    •Head-to-head comparison of the immune response day 28 after each additional dose and the primary endpoints of the Tri-VOICE plus study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with oncological or hematological malignancy
    • Vaccinated with priming and boosting ChAd-0x1-S vaccine
    • Ability to provide informed consent
    E.4Principal exclusion criteria
    • Women who are pregnant or breastfeeding
    • Immune deficiency not related to cancer or cancer treatment
    • Allergy (multiple)
    E.5 End points
    E.5.1Primary end point(s)
    The first co-primary endpoint is the difference in SARS-CoV-2 IgG levels, before and 28 days after third dose of COVID-19 mRNA vaccine BNT162b2 after 2 doses of ChAd-Ox1-S vaccine.

    The second co-primary endpoint is the difference in SARS-CoV-2 IgG before and 28 days after the administration of fourth dose of the COVID-19 mRNA BNT162b2 vaccine after third dose of BNT162b2 and previous 2 doses of ChAd-Ox1-S vaccine
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28 after booster shot BNT162b2 vaccine
    E.5.2Secondary end point(s)
    •To investigate the safety of the third and fourth dose of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®)
    •To investigate the kinetics and longevity of the antibody response after third and fourth dose
    •To investigate the proportion of high-responders per current treatment cohort from the day of receiving an additional shot of BNT162b2 vaccine and 28 days thereafter.
    •To analyze the IgG titer of neutralizing antibodies, only in cases lower limit of quantification for the detection of binding antibodies is exceeded, at all the different timepoints
    •Assessment of the cellular immune response
    •Assessment of the SARS-Cov2 breakthrough infection rate
    •Head-to-head comparison of the immune response day 28 after each additional dose and the primary endpoints of the Tri-VOICE plus study
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) 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 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
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 state182
    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 Decision2021-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-09
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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