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    Summary
    EudraCT Number:2021-003386-35
    Sponsor's Protocol Code Number:INSIGHT-016
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-07-13
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-003386-35
    A.3Full title of the trial
    SARS-CoV-2 vaccination strategies in previous hospitalised and recovered COVID-19 patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination for Recovered Inpatients with COVID-19 (VATICO)
    A.3.2Name or abbreviated title of the trial where available
    VATICO
    A.4.1Sponsor's protocol code numberINSIGHT-016
    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 SponsorRegents of the University of Minesota
    B.1.3.4CountryUnited States
    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 Insitute of Health
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHIP - Rigshospitalet, University of Copenhagen
    B.5.2Functional name of contact pointJens Lundgren
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number453545 5757
    B.5.5Fax number453647 3340
    B.5.6E-mailjens.lundgren@regionh.dk
    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 concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOMIRNATY
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    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 Spikevax dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN S.L.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSpikevax dispensation for injection
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine Moderna (CX-024414)
    D.3.9.4EV Substance CodeSUB207171
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, and who are still [TICO assignment] blinded, and who are still within 28 to 90 days after initial TICO randomization, will be randomized in this 2x2 factorial design to one of four groups of the Moderna mRNA 1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines)
    E.1.1.1Medical condition in easily understood language
    Same as above
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    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
    1. Among participants in TICO who were randomized to placebo, to estimate the difference in NAb levels at Week 48 to the Moderna mRNA-1273 vaccine or the Pfizer BNT162b2 vaccine among participants who are vaccinated early (i.e. at time of enrolment into this protocol, within 28 to 90 days of enrolment in TICO) versus deferred (i.e. 12 weeks after enrolment into this protocol).

    2. Among participants in TICO who were randomized to placebo, to estimate the difference in neutralizing antibody levels at Week 48 to the Moderna mRNA-1273 vaccine or the Pfizer BNT162b2 vaccine among participants who are vaccinated once versus twice.
    E.2.2Secondary objectives of the trial
    1 Estimate difference in NAb response to the Moderna vaccine or the Pfizer vaccine
    2 Explore safety of the Moderna or the Pfizer vaccines in persons with prior COVID-19 who did or did not receive prior TICO-defined invest. agents
    3 Explore whether the timing of vaccination and/or use of one or two doses affect the safety/tolerability
    4 Estimate the percentage in each of the four vaccination groups with differences from baseline to Week 48
    5 Compare the one and two-dose vaccination strategies for the percentage of participants who experience a composite outcome of death, SAE, grade 3, grade 4 AEs from vaccination
    6 Compare the percentage of who experience death or an SAE through 24 weeks
    7 Explore whether host characteristics, co-morbidities, co-medication, the course of prior COVID-19, type of vaccine, interval between enrolment in this protocol and baseline immune status affect humoral responses to SARS-CoV-2 vaccination and kinetics in NAb titers from 12 weeks after vaccination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participating in the TICO trial and received a selected blinded investigational agent or placebo for that agent at selected sites.
    NOTE: A list of selected investigational agents will be posted on the INSIGHT website.

    2. Willingness to strictly adhere to the randomly allocated dosage number and schedule for vaccine administration
    3. Participant is between Day 28 and Day 90 TICO visits inclusive at the time of randomization
    4. At the time of screening for this protocol, experienced sustained recovery (i.e. the primary endpoint in TICO) for at least two consecutive weeks, i.e. having returned uninterrupted to the person’s premorbid living facility (or equivalent) for at least 2 consecutive weeks
    5. Ability and willingness of participant (or legally authorized representative [LAR]) to provide informed consent prior to initiation of any study procedures
    E.4Principal exclusion criteria
    1. Receipt of a SARS-CoV-2 (also known as COVID-19) vaccine after enrollment into TICO. Participants who received a SARS-CoV-2 vaccine prior to enrollment in TICO may be enrolled in this substudy

    2. Known allergy to any component of the study eligible vaccine(s)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is neutralizing antibody levels specific to the Moderna or Pfizer vaccine at Week 48 after randomization.

    Comparisons will be evaluated using the ratio of geometric mean responses. Antibody levels will be log10 transformed and summarized with stratified analysis of covariance
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48 after randomization
    E.5.2Secondary end point(s)
    1. Antibody levels 12 weeks after the first vaccination (i.e. at Weeks 12 and 24 depending on randomization to vaccinate immediately or deferred).
    2. Estimated percentage of participants in each of the four vaccination groups with > 16, 8-16, 4-8, 2-4, and < 2-fold differences in NAbs from baseline to Week 48 and from just before vaccination to 12 weeks thereafter.
    3. Relative pre-vaccine to post-vaccine change in NAb response defined as the ratio, post-vaccine level/pre-vaccine level. The pre-vaccine NAb measurement will be obtained immediately before the first dose of the vaccine (i.e. at Week 0 or 12) and the post-vaccine measurement will be obtained at Week 12 or at Week 24, depending on whether the vaccine was administered immediately or deferred.
    4. Composite outcome of death, serious adverse event (SAE), grade 3 AEs, and grade 4 AEs within 12 weeks following randomization for the immediate group and from Week 12 to Week 24 in the deferred group.
    5. Deaths or SAEs through Week 24.
    6. The percentage of participants assigned to 2nd dose who do not receive it: a) for any reason and b) due to an AE following the 1st dose.
    7. Non-adherence to the assigned treatment strategy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As above
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Randomisation to one of the 4 treatment groups will depend on the treatment in TICO study
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    Nigeria
    Peru
    Singapore
    Uganda
    Ukraine
    United States
    Denmark
    Spain
    Sweden
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 640
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 640
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INSIGHT (International Network for strategic Initiatives in Global HIV Trials
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-12-21
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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