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    Summary
    EudraCT Number:2021-002171-19
    Sponsor's Protocol Code Number:HEVACC
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-002171-19
    A.3Full title of the trial
    Heterologous vaccination with a Vaxzervia (ChAdOx1-S) prime and a Comirnaty (BNT162b2) boost
    Heterologe Impfung mit Vaxzervia (ChAdOxl-S, AstraZeneca) gefolgt von Comirnaty (BNT162b2, Pfizer)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Heterologous vaccination with a Vaxzervia (ChAdOx1-S) prime and a Comirnaty (BNT162b2) boost
    Heterologe Impfung mit Vaxzervia (ChAdOxl-S, AstraZeneca) gefolgt von Comirnaty (BNT162b2, Pfizer)
    A.4.1Sponsor's protocol code numberHEVACC
    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 SponsorMedizinische Universität Innsbruck, Institut für Virologie
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Innsbruck
    B.5.2Functional name of contact pointSponsor representative and PI
    B.5.3 Address:
    B.5.3.1Street AddressPeter-Mayr-Straße 4b
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number00435212900371737
    B.5.6E-maildorothee.vonlaer@i-med.ac.at
    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 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.3.1Product 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOVID-19 mRNA vaccine
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S [recombinant])
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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.3.1Product nameVaxzevria
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOVID-19 Vaccine (ChAdOx1-S [recombinant])
    D.3.9.3Other descriptive nameCOVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    D.3.9.4EV Substance CodeSUB207764
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.5 × 10^8
    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 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S [recombinant])
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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.3.1Product nameVaxzevria
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOVID-19 Vaccine (ChAdOx1-S [recombinant])
    D.3.9.3Other descriptive nameCOVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    D.3.9.4EV Substance CodeSUB207764
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.5 × 10^8
    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 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
    Immunization for SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    Immunisierung gegen SARS-CoV-2
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021433
    E.1.2Term Immunization
    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
    Primary objectives:
    1. To determine whether the immune response to vaccine SARS‐CoV‐2 spike protein is at least as effective for the heterologous prime‐boost regime Vaxzevria followed by Comirnaty as in the
    approved homologous Vaxzevria and Comirnaty regimen.
    2. To determine immune responses in non‐responders after a third immunization
    3. To determine immune responses all participants after a third immunization
    E.2.2Secondary objectives of the trial
    1. Potentially show clinical efficacy against infection, especially with B.1.351, B.1.1.7+E484K and other immune escape variants
    2. To analyze in detail safety and tolerability after the second vaccination especially in the heterologous arm. (clinical, lab)
    3. To evaluate the clinical course and outcome of COVID‐19 diseases after vaccination with ChAdOx1‐S prime & boost vs. ChAdOx1‐S prime and BNT162b2 boost vs BNT162b2 prime & boost
    4. To analyze safety and tolerability after the 3rd dose vaccination (clinical, lab)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject provides written informed consent
    2. Participant is ≥ 18 and ≤ 65 years of age on the day of signing the ICF
    3. Individuals that are eligible for vaccination according to the Austrian vaccination plan.
    4. Participants that have been vaccinated with either ChAdOx1-S prime within the last 12 weeks or BNT162b2 prime within the last 3 – 6 weeks
    5. Subject understands and agrees to comply with study procedures
    6. Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
    7. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
    - has a negative urine pregnancy test at screening
    - has agreed to practice adequate contraception from providing consent until 3 months after administration of study vaccine
    - is not currently breastfeeding

    Adequate female contraception is defined as consistent and correct use of an approved contraceptive method, for example:
    • Barrier method (condoms, diaphragm, cervical cap) used in conjunction with spermicide
    • Prescription hormonal contraceptive taken administered via oral (pill), transdermal (patch), subdermal or IM route
    • Intrauterine device
    • Sterilization of a female participant`s monogamous male partner prior to study inclusion
    Cave: periodical abstinence (eg calendar, ovulation, symptothermal,...) and withdrawal are not acceptable methods of contraception.

    8. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as: surgically sterile (history of bilateral dubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (amenorrhea for  12 consecutive months prior to Screening without an alternative medical cause).
    9. Participants agrees to not donate bone marrow, blood and blood products from the study vaccine administration until 3 months after receiving the study vaccine

    Amendment protocol 2021-08-18: 3rd vaccination

    1. Subjects that have received the second dose of vaccination within this study.

    2. No neutralizing antibodies on day 90 post second dose (only for participants that will receive the third dose between day 110 and 180). All other participants will be offered a third dose between
    day 200 and 260 after the second dose, independent of their antibody titers.
    3. Subject provides written informed consent
    4. Subject understands and agrees to comply with study procedures
    5. Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
    6. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
    - has a negative urine pregnancy test at screening
    - has agreed to practise adequate contraception from providing consent until 3 months after administration of study vaccine
    - is not currently breastfeeding

    8. Participants agrees to not donate bone marrow, blood and blood products from the study vaccine administration until 3 months after receiving the study vaccine
    E.4Principal exclusion criteria
    1. Participant has already received full vaccination against SARS-CoV-2
    2. Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to either prevent or treat COVID-19
    3. Participant has received/plans to receive a non-study vaccine within 14 days prior to or after any dose of IP
    4. Participant has a contraindication to IM injections and blood draws (eg, bleeding disorders)
    5. Participants has a known or suspected allergy or history of anaphylaxis, urticaria or other significant adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to the IB)
    6. Subjects with previous positive PCR-test result for SARS-CoV-2 or positive anti-SARS-CoV-2 N protein antibody test
    7. History of leukemia, lymphoma, or underlying bone marrow disorder (eg, myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant.
    8. Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment.
    9. Has participated in an interventional clinical study within 30 days prior to study inclusion

    Amendment protocol 2021-08-18: 3rd vaccination

    1. Participant already received a third dose of vaccination.
    2. Subjects with positive PCR‐test result for SARS‐CoV‐2 after study enrolment or a positive anti‐SARS‐CoV‐2 N antibody test on day 180.
    E.5 End points
    E.5.1Primary end point(s)
    1a Level of neutralizing antibodies against wild‐type and immune escape variants in the 3 study groups at 10, 30, 90 and 180 days post boost.
    1b Level of neutralizing antibodies against wild‐type and immune escape variants at 10, 30, 90 and 180 days post 3rd immunization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 10, Day 30, Day 90, Day 180

    Amendment protocol 2021-08-18: 3rd vaccination
    Day 10, Day 30, Day 90, Day 180 after 3rd vaccination
    E.5.2Secondary end point(s)
    1. Level of T cell responses against SARS‐CoV‐2 spike protein peptides pools per subgroup at 30 days.
    2. Occurrence of breakthrough infection with wild type, B.1.351 and other immune escape variants of SARS‐CoV‐2
    3. Occurrence of adverse events, serious adverse events and adverse events of special interest
    4. The clinical course (hospitalization, ICU admission) and outcome of COVID‐19 diseases (recovery, long‐Covid mortality).
    5. Occurrence of adverse events, serious adverse events and adverse events of special interest after 3rd immunization
    6. Level of T cell responses against SARS‐CoV‐2 spike protein peptides pools in non‐responders after 3rd immunization
    7. Occurrence of breakthrough infection with wild type, B.1.351 and other immune escape variants of SARS‐CoV‐2 after 3rd immunization
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 - day 10 and weekly antigen-tests until day 180 after Boost shot

    Amendment protocol 2021-08-18: 3rd vaccination
    Day 1 - day 10 and weekly antigen-tests until day 180 after 3rd 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Amendment protocol 2021-08-18: arm Vaxzevria twice had to be closed, design switched to open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 2800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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 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 Decision2021-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-11
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