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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-005564-21
    Sponsor's Protocol Code Number:SIRAVA
    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:2021-11-09
    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 number2021-005564-21
    A.3Full title of the trial
    Five-year boostability after single-visit single-dose intramuscular rabies pre-exposure prophylaxis.
    Anamnestische antistofrespons vijf jaar na een enkele rabiesvaccinatie als pre-exposure profylaxe.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    How well does the immune system remember vaccination against rabies five years after a single shot?
    Hoe goed herinnert het afweersysteem een inenting tegen hondsdolheid vijf jaar na een enkele injectie?
    A.3.2Name or abbreviated title of the trial where available
    SIRAVA
    SIRAVA
    A.4.1Sponsor's protocol code numberSIRAVA
    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 SponsorLeiden University Medical Center
    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 supportBavarian Nordic A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointDepartment of Infectious Diseases
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.6E-mailL.G.Visser@lumc.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.2.1.1.1Trade name Rabipur
    D.2.1.1.2Name of the Marketing Authorisation holderBavarian Nordic A/S
    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.3.1Product nameRabipur
    D.3.4Pharmaceutical form Lyophilisate and solvent 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 INNRabies vaccine
    D.3.9.3Other descriptive nameRABIES VIRUS (INACTIVATED) STRAIN FLURY LEP
    D.3.9.4EV Substance CodeSUB25746
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.5
    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 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
    Healthy volunteers
    Gezonde vrijwilligers
    E.1.1.1Medical condition in easily understood language
    Rabies vaccination
    Vaccinatie tegen hondsdolheid
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10069589
    E.1.2Term Rabies 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
    To demonstrate the presence of a rapid and adequate anamnestic antibody response against rabies virus vaccine five years after primary vaccination with a single intramuscular dose (1.0 mL) of rabies vaccine. The rate of increase in geometric mean concentrations of RVNA observed at day 8 after a standard 2-dose PEP vaccination schedule should be non-inferior to that of the reference group who received primary vaccination with 2-dose PrEP.
    We vergelijken de langdurige werking en veiligheid van een enkele vaccinatie tegen hondsdolheid met twee vaccinaties tegen hondsdolheid. Vijf jaar na pre-exposure profylaxe kijken we of de stijging in RVNA titers op dag 8 na post-exposure profylaxe non-inferior is bij mensen die 1 vaccinatie hebben ontvangen vergeleken met mensen die 2 vaccinaties hebben ontvangen.
    E.2.2Secondary objectives of the trial
    1. To describe the kinetics of rabies virus neutralizing antibody levels in healthy young adults, who received single-visit single-dose rabies PrEP or two-visit PrEP, during a five-year follow-up.

    2. To describe the kinetics of rabies-specific memory B-cells in healthy young adults, who received single-visit single-dose rabies PrEP or two-visit PrEP, during a five-year follow-up.
    1. De kinetiek beschrijven van RVNA titers in gezonde jongvolwassenen gedurende een follow-up van vijf jaar na ofwel een enkele ofwel twee vaccinaties tegen hondsdolheid.

    2. De kinetiek beschrijven van rabies-specifieke B-geheugencellen in gezonde jongvolwassenen gedurende een follow-up van vijf jaar na ofwel een enkele ofwel twee vaccinaties tegen hondsdolheid.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 years and ≤40 years
    • Good health according to investigator
    • Willingness and ability to adhere to the study regimen
    • Able to provide informed consent
    • Naïve to rabies exposure or vaccination
    • Willing to comply to a follow-up of 5 years
    • Unlikely to require rabies PrEP in next 5 years
    • Minimaal 18 en maximaal 40 jaar oud
    • Goede gezondheid
    • Bereid en in staat tot het volhouden van de studieplanning
    • In staat om informed consent te verlenen
    • Niet eerder blootgesteld aan of gevaccineerd tegen rabies
    • Bereid om aan een follow-up van vijf jaar deel te nemen
    • Waarschijnlijk geen PEP nodig in de komende vijf jaar
    E.4Principal exclusion criteria
    • History of previous rabies vaccination
    • Suspected previous vaccination against rabies
    • Known or suspected severe allergy against egg protein
    • Known or suspected allergy against any of the other vaccine components
    • History of unusual or severe reactions to any previous vaccination
    • History of (pre)syncope associated with medical procedures involving needles
    • Immunocompromized state due to illness or medication
    • Administration of plasma or blood products three months prior to inclusion
    • (hydroxy)chloroquine or mefloquine use
    • History of any neurological disorder including epilepsy
    • Pregnancy during study visits in which the participant is vaccinated
    • Breastfeeding during and up to 4 weeks after study visits in which the participant is vaccinated
    • Any current infectious disease other than seasonal cold
    • Bleeding disorders or use of anticoagulants
    • Eerder gevaccineerd tegen rabies
    • Vermoeden van eerdere vaccinatie tegen rabies
    • Bekende of vermoede ernstige allergie tegen eiwit
    • Bekende of vermoede allergie tegen overige vaccincomponenten
    • Voorgeschiedenis van ongebruikelijke of ernstige reacties op eerdere vaccinaties
    • Voorgeschiedenis van (pre)syncope bij medische procedures met naalden
    • Immunogecompromitteerd door ziekte of medicatie
    • Toedeniening van plasma of bloedproducten in de drie maanden voor inclusie
    • Gebruik van (hydroxy)chloroquine of mefloquine
    • Voorgeschiedenis van een neurologische aandoening, waaronder epilepsie
    • Zwangerschap tijdens studiebezoeken waarbij de deelnemer gevaccineerd wordt
    • Borstvoeding geven tijdens en tot 4 weken na studiebezoeken waarbij de deelnemer gevaccineerd wordt
    • Elke andere infectieziekte dan seizoensverkoudheid
    • Bloedziekten of het gebruik van anticoagulantia
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of rabies neutralizing antibodies between day 1 and day 8 after revaccination.
    De stijging van geometrisch gemiddelde concentraties (GMC) van rabies-neutraliserende antistoffen tussen dag 1 en 8 na revaccinatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years after pre-exposure immunization.
    Vijf jaar na pre-exposure profylaxe.
    E.5.2Secondary end point(s)
    Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination.
    Percentage of subjects with RVNA titers>0.5 IU/mL at D1, D8 and D15, after the simulated post-exposure vaccination.
    Percentage of subjects with RVNA titers>3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP.
    GMCs at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination, and at D1, D8 and D15 after the simulated post-exposure vaccination.
    Percentage proefpersonen met RVNA titer >0.5 IU/mL op D1, D57 of D64, Y1, Y2 en Y5 na primaire vaccinatie.
    Percentage proefpersonen met RVNA titers>0.5 IU/mL op D1, D8 en D15, na gesimuleerde post-exposure vaccinatie.
    Percentage proefpersonen met RVNA titers>3 IU/mL, en percentage proefpersonen met >5 IU/mL op dag 8 na gesimuleerde post-exposure post-exposure vaccinatie.
    GMCs op D1, D57 of D64, Y1, Y2 en Y5 na primaire vaccinatie, en op D1, D8 en D15 na gesimuleerde post-exposure vaccinatie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination.
    Percentage of subjects with RVNA titers>0.5 IU/mL at D1, D8 and D15, after the simulated post-exposure vaccination.
    Percentage of subjects with RVNA titers>3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP.
    GMCs at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination, and at D1, D8 and D15 after the simulated post-exposure vaccination.
    Some timepoints contain a margin in which it is acceptable that the study visit takes place. For D57/D64, this margin is -2 days and +7 days. For year 1, year 2 and year 5, this margin is -7 days and +7 days.
    Percentage proefpersonen met RVNA titer >0.5 IU/mL op D1, D57 of D64, Y1, Y2 en Y5 na primaire vaccinatie.
    Percentage proefpersonen met RVNA titers>0.5 IU/mL op D1, D8 en D15, na gesimuleerde post-exposure vaccinatie.
    Percentage proefpersonen met RVNA titers>3 IU/mL, en percentage proefpersonen met >5 IU/mL op dag 8 na gesimuleerde post-exposure post-exposure vaccinatie.
    GMCs op D1, D57 of D64, Y1, Y2 en Y5 na primaire vaccinatie, en op D1, D8 en D15 na gesimuleerde post-exposure vaccinatie.
    Rondom enkele tijdpunten zit een marge waarin het studiebezoek plaats mag vinden. Voor D57/D64is dat -2 dagen en +7 dagen. Voor jaar 1, jaar 2 en jaar 5 is dat -7 dagen en +7 dagen.
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    Laboratorium (analyse) geblindeerd betreft allocatie
    Laboratory blinded from allocation
    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
    Standaard pre-exposure profylaxe (2 vaccinaties)
    Standard pre-exposure prophylaxis (2 vaccinations)
    E.8.2.4Number of treatment arms in the trial2
    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 years6
    E.8.9.1In the Member State concerned months0
    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: 240
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    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 Decision2021-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-28
    P. End of Trial
    P.End of Trial StatusOngoing
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