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    Summary
    EudraCT Number:2020-005997-82
    Sponsor's Protocol Code Number:900452-CT-20-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-27
    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 number2020-005997-82
    A.3Full title of the trial
    Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study
    (ACT-study)
    Anti-COVID19 AKS-452 fase I/II VaccinaTie Studie (ACT-Studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination phase I/II study against COVID-19
    Vaccinatie fase I/II studie tegen COVID-19
    A.3.2Name or abbreviated title of the trial where available
    ACT-Study
    ACT-Studie
    A.4.1Sponsor's protocol code number900452-CT-20-001
    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 SponsorUMCG
    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 supportAkston Biosciences Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointGooitzen van Dam
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31622914614
    B.5.6E-mailGo@tracercro.com
    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 No
    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 nameAKS-452
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAKS-452
    D.3.9.3Other descriptive nameCOVID-19 vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0 to 100
    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) 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 Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    The corona virus, COVID-19
    Het corona virus, COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    To evaluate the safety, tolerability and humoral immunogenicity profile of AKS-452 following
    two injections administered 28 days apart in a combinatorial phase I/II single-center, open label
    clinical study.
    Het evalueren van de veiligheid, dosis, verdraagzaamheid en exploratieve efficacy van de humorale immunogeniciteit van AKS-452 na 1 of 2 toegediende injecties (met daartussen 28 dagen) in een gecombineerde fase I/II studie.
    E.2.2Secondary objectives of the trial
    Evaluate the cell-mediated immune responses to AKS-452 induced by two consecutive
    immunizations to estimate peak Ab titers and duration of Ab response.
    Evalueren van de cell-gemedieerde immuunrespons tegen AKS-452 geinduceerd door 2 opeenvolgende immunisaties, met als doel om de piek titer Ab en duur Ab response in te schatten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-65 years (extremes included), males and females. This will be expanded to 85 years of age for phase II.
    - SARS-CoV-2 serology (an anti-SARS-Cov-2 SP-specific IgG ELISA):
    o Tests negative for IgG titer and no known prior SARS-Cov-2 infection
    - Body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive
    - General good health, without significant medical illness, as determined via physical exam findings, ECG or vital signs
    o Note: one retest of vital functions and ECG is allowed within the screening window
    - No clinically significant laboratory abnormalities as determined by the investigator
    o Note: one retest of lab tests is allowed within the screening window
    - Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose and procedures required for the study and is willing to participate in the study
    - Willing to adhere to the prohibitions and restrictions specified in this protocol
    - For phase I: nNo invitation is received to get a registered vaccine within the first 2 months after the moment of participation in this study. For phase II this criterium will be abandoned as the whole population will have received an invitation to get a registered vaccine. Therefore, a participant should agree not to receive a registered vaccine within 28 days after receiving the last AKS-452 vaccine.
    - Negative hepatitis panel (including hepatitis B surface Ag and anti-hepatitis C virus Abs) and negative human immunodeficiency virus Ab and Ag screens at screening
    - Female subjects should fulfil one of the following criteria:
    o At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone >30 mIU/mL) at screening;
    o Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
    o Will use adequate forms of contraceptives from screening to discharge.
    - Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge
    o Note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, double barrier, sterilization and vasectomy
    - Female subject has a negative pregnancy test at screening and upon check-in at the clinical site.
    o Note: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at other (dosing) visits, in all women.
    Leeftijd 18-85 jaar, mannen en vrouwen
    - SARS-CoV-2 serologie (een kwantitatieve anti-SARS-Cov-2 SP/RBD-specifieke IgG ELISA):
    o test negatief voor IgG titer and geen bekende SARS-CoV-2 infectie
    - Voor fase 1: geen uitnodiging gehad om in de eerste 2 maanden na deelname aan de studie een reeds geregistreerd anti-COVID19 vaccin te ontvangen. Voor fase 2 zal dit criterium komen te vervallen aangezien de gehele Nederlandse bevolking een uitnodiging zal hebben gehad. Daarom moet een deelnemer instemmen geen ander vaccin te ontvangen gedurende minimaal 28 dagen na het laatste AKS-452 vaccin.
    - Body mass index (BMI) tussen19.0 and 30.0 kg/m2,
    - In algemene goede gezondheid, zonder significante medische aandoeningen, bepaald door een lichamelijk onderzoek, ECG en vitale functies
    o NB: een nieuwe meting van vitale functies en ECG is toegestaan in het screening window
    - Geen afwijkende lab waarden, bepaald door de onderzoeker
    NB: een nieuwe meting van labwaarden is toegestaan in het screening window
    - Een vrijwillig getekend Informed Consent Formulier, waaruit blijkt de de deelnemer op de hoogte is van het doel en handelingen van de studie en de deelnemer vrijwillig deelneemt, voordat enige studie gerelateerde handelingen uitgevoerd worden
    - Bereid om zich aan de restricties en leefregels, die in dit protocol beschreven zijn te houden.
    - Negatief hepatitis panel (inclusief hepatitis B surface antigen en anti-hepatitis C virus antilichamen) en negatief human immunodeficiency virus (HIV) antilichamen en antigen tests op het moment van screening
    - Vrouwelijke deelnemers dienen in ieder geval aan 1 van de volgende criteria te voldoen
    o Tenminste 1 jaar na de menopauze (Amenorroe >12 maanden en/of follicle-stimulating hormone >30 mIU/mL) op het moment van de screening;
    o Chirurgische sterilisatie (bilaterale ovariëctomie, hysterectomie, of tubaligatie);
    o Gebruik van adequate contraceptie van screening tot het einde van de studie .
    - Vrouwelijke proefpersonen in de vruchtbare leeftijd en seksueel actieve mannen met een vrouwelijke partner in de vruchtbare leeftijd dienen gebruik te maken van adequate contraceptie van screening tot het einde van de studie .
    - Vrouwelijke proefpersonen dienen een negatieve zwangerschapstest te hebben op het moment van screening en check-in van de studie.
    o NB: een serum zwangerschapstest wordt uitgevoerd bij de screening en een urine test op alle andere momenten.
    E.4Principal exclusion criteria
    - Pregnant of breast feeding females
    - Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, hematologic,
    rheumatologic, endocrine, autoimmune, or renal disease
    - Any laboratory test which is abnormal, and which is deemed by the Investigator(s) to be
    clinically significant
    - Behavioral or cognitive impairment or psychiatric disease that in the opinion of the
    investigator affects the ability of the subject to understand and cooperate with the study
    protocol
    - Current alcohol/illicit drug/nicotine abuse or addiction: history or evidence of current drug
    use or addiction (positive drug screen for amphetamines, barbiturates, benzodiazepines,
    cannabinoids, cocaine, or opiates) or signs of excessive use of alcohol at screening and Day -2.
    - Presence of any febrile illness (T > = 38.0°C or lab confirmed viral disease (PCR)) or
    symptoms suggestive of a viral respiratory infection within 1 weeks prior to vaccination
    - Use of corticosteroids (excluding topical preparations for cutaneous or nasal use) or use
    of immunosuppressive drugs within 30 days before inoculation
    - A history of anaphylaxis, history of allergic reaction to vaccine, known allergy to one of the
    components in AKS-452. Mild allergies without angio-oedema or treatment need can be
    included if deemed not to be of clinical significance (including but not limited to allergy to
    animals or mild seasonal hay fever)
    - A history of asthma within the past 10 years, or a current diagnosis of asthma or reactive
    airway disease associated with exercise
    - Receipt of a licensed vaccine within 4 weeks prior to viral inoculation
    - Received any experimental SARS-CoV-2 vaccine or drug
    - Receipt of blood or blood-derived products (including immunoglobulin) within 6 months
    prior to vaccination.
    - Receipt of another investigational agent within 30 days or 5 times the product half-life
    (whichever is longest) prior to vaccination
    - Shares household with /works with immunocompromised individual(s), adults with
    significant cardiopulmonary disease, persons with significant asthma, institutionalized
    elderly or elderly with functional disability
    - Deprived of freedom by an administrative or court order or in an emergency setting
    - Any condition that in the opinion of the principal investigator (PI) would jeopardize the
    safety or rights of a person participating in the trial or would render the person unable to
    comply with the protocol.
    - Zwanger / borstvoeding gevende vrouwen
    - Aanwezigheid van klinisch significante neurologische, cardiale, pulmonale, hematologische, hematologische, reumatologische, endocriene, autoimmuun, of nier aandoeningen
    - Enige afwijkende laboratorium test, en welke door de onderzoekers als klinisch significant wordt beoordeeld
    - Gedrags- of cognitieve beperkingen of psychiatrische aandoeningen, die naar de mening van de onderzoeker de mogelijkheden beperkt voor de proefpersoon om objectief het studieprotocol te kunnen beoordelen of deel te nemen
    - Op dit moment aanwezige alcohol of drugs / nicotine verslaving / misbruik, in het verleden drugs gebruik of verslavingen (i.e. in verleden positieve tests voor amphetamines, barbituraten, benzodiazepines, cannabinoids, cocaine of opiaten) of tekenen van excessief alcoholgebruik ten tijde van de screening en 2 dagen voordien.
    - Aanwezigheid van koorts (T>=38.0 °C) of laboratorium testen die een virale ziekte vermoeden (PCR-test) of symptomen die wijzen op een virale longinfectie minder dan 1 week vooraf aan de vaccinatie
    - Gebruik van corticosteroïden (m.u.v. uitwendig gebruik for huid of nasaal gebruik), of het gebruik van immuunsuppressiva minder dan 30 dagen vooraf aan de vaccinatie.
    - Patiënten met een voorgeschiedenis van anaphylaxis, allergische reacties op vaccins, bekende allergie tegen 1 van de componenten van AKS-452. Milde allergieën zonder angio-oedeem of noodzaak tot behandeling kunnen geincludeerd worden indien ingeschat wordt dat dit niet van klinische relevantie is (ingesloten, maar niet gelimiteerd tot allergieën voor dieren of milde seizoensgebonden hooikoorts)
    - Voorgeschiedenis van asthma de afgelopen 10 jaar, of een huidige diagnose van asthma of reactieve luchtwegen geassocieerd met inspanning / sporten
    - Toediening van een gelicenseerd vaccin 4 weken voorafgaan aan de vaccinatie met AKS-452
    - Het ontvangen van enig experimenteel SARS-CoV-2 vaccin of medicament
    - Het ontvangen van bloed of bloedproducten (inclusief immunoglobulines) minder dan 6 maanden voorafgaand aan de vaccinatie met AKS-452
    - Het ontvangen van enig ander onderzoek product / medicament de afgelopen 30 dagen, of 5x de halfwaarde tijd (welke het langsgereden is) vooraf aan de vaccinatie
    - Gedeelde huishoudens waarin immuungecompromiteerd individuen aanwezig zijn, of volwassenen met significante hartvaatziekten, longaandoeningen, asthma, geïnstitutionaliseerde ouderen of ouderen met functionele beperkingen.
    - Deelnemers die in opsluiting verkeren t.g.v. een gerechtelijke procedure of in een acute omstandigheid
    - Enige conditie die volgens de Principal Investigator de veiligheid van de proefpersoon in het geding zou kunnen brengen door deelname in de trial, of onmogelijkheid het protocol uit te voeren van de studie
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the safety, tolerability and humoral immunogenicity profile (i.e., SP/RBD-specific IgG titers) of AKS-452 following a one-injection regimen and a two-injection regimen administered 28 days apart in a combined Phase I/II single-center, open-label clinical study.

    - Main study parameter for phase I is safety and dose-finding in a classical 3x3 dosefinding
    design (In this phase I we have 6 cohorts), with an expansion to 10 subjects per dosing-cohort up to a total of 60 subjects (6x10)
    - Main study parameter for phase II is safety and initial efficacy measurement as a
    preparatory study towards a sufficient powered phase III study design. Phase II will consist of two-arms of 58
    subjects per cohort all receiving the active vaccine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    0, 28, 56, 90, and 180 days
    0,28, 56, 90, en 180 dagen
    E.5.2Secondary end point(s)
    - Anti-SARS-CoV-2 SP/RBD IgG titers at days 0, 28, 56, 90, and 180.
    - Serum titer inhibition of recombinant ACE2-SP/RBD binding and/or neutralization of live SARS-CoV-2 virus infection of live cells (Plaque Reduction Neutralization Test, PRNT) at days 0, 28, 56, 90, and 180.
    - T-cell responses measured ex vivo using PBMCs to measure SP/RBD-specific T cell production of IFN-g and Th1/Th2/Th17 related cytokines via ELISpot or other Ag-specific flowcytometric-based assays on days 0, 7(subset), 28, 35 (subset), 56, 90, and 180.
    - IgG-class, anti-SARS-CoV-2 SP RBD Ab titers op dag 0,28,56,90 en 180.
    - Serum titer remming (ACE2-SP/RBD binding) of levend virus neutralization (PRNT) assays voor SARS-CoV-2 virus infectie van levende cellen op dag 0,28,56,90 en 180.
    - T-cell responses gemeten ex vivo gebruik makende van PBMCs om SP/RBD-specifieke T cell
    production of IFN-g and other Th1/Th2/Th17 cytokines te meten via ELISpot of andere Ag-specifieke
    flowcytometrische assays op dag 0, 7(subset), 28, 35 (subset), 56, 90, en 180
    E.5.2.1Timepoint(s) of evaluation of this end point
    0, 7(subset), 28, 35 (subset), 56, 90, and 180 days
    0, 7(subset), 28, 35 (subset), 56, 90, en 180 dagen
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Phase I will not be randomized, Phase II is randomized
    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.8.2.4Number of treatment arms in the trial3
    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
    Laatste bezoek, laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 176
    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 state176
    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
    geen
    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 Decision2021-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-09
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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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