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    Summary
    EudraCT Number:2012-004938-42
    Sponsor's Protocol Code Number:EHRVI
    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:2012-11-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-004938-42
    A.3Full title of the trial
    Experimental Human Rhinovirus Infection, a randomized placebo-controlled pilot study
    Experimentele menselijke Rhinovirus Infectie, een gerandomiseerde placebo-gecontroleerde pilot studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Experimental Human Rhinovirus Infection
    Experimentele menselijke Rhinovirus Infectie
    A.3.2Name or abbreviated title of the trial where available
    EHRVI
    EMRVI
    A.4.1Sponsor's protocol code numberEHRVI
    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 SponsorRadboud University Nijmegen Medical Centre
    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 supportRadboud University Nijmegen Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen Medical Centre
    B.5.2Functional name of contact pointR. Koch
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243668420
    B.5.5Fax number0031243541612
    B.5.6E-mailR.Koch@ic.umcn.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 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 nameHuman Rhinovirus Type 16
    D.3.2Product code HRV-16
    D.3.4Pharmaceutical form Nasal drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhuman rhinovirus 16
    D.3.9.2Current sponsor codeHRV-16
    D.3.9.3Other descriptive namehuman rhinovirus 16
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50 cell culture infective dose 50
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman Rhinovirus 16 (HRV-16), isolated from nasal lavage of a healthy female. Subsequently manufactered according to GMP standards.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolvent for nasal use
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Viral infections in general, and the "common cold" induced by HRV-16 in particular.
    Virale infecties in het algemeen en specifiek verkoudheid geïnduceerd door HRV-16
    E.1.1.1Medical condition in easily understood language
    Infections caused by viruses in general, and the "common cold" induced by HRV-16 in particular.
    Infecties veroorzaakt door virussen in het algemeen en specifiek verkoudheid geïnduceerd door HRV-16
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061494
    E.1.2Term Rhinovirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To set up the Human Rhinovirus (HRV)-model in our centre, using HRV serotype 16 (HRV-16).
    Om het menselijk rhinovirus model op te zetten in ons centrum, gebruik makend van HRV serotype 16 (HRV-16)
    E.2.2Secondary objectives of the trial
    To determine:
    1. The viral load of HRV-16 infection in nasal washes
    2. The incubation period of HRV-16 infection.
    3. The effects of HRV-16 infection on cold symptoms, temperature, and spirometry.
    4. Suitable inflammatory parameters (and their kinetics) that play a role in the HRV-16-induced local inflammatory response
    5. Whether HRV-16 infection can induce a systemic immune response and its kinetics
    6. The effect of HRV-16 seropositivity on the clinical and immunological response to re-infection with HRV-16.
    7. If a subject is protected against re-infection with HRV-16 within one week (tolerance formation to HRV), and if so which mechanisms play a role (local and systemic)
    8. Whether HRV-16 infection modulates the immune response of circulating leukocytes by measuring the cytokine response, of leukocytes ex vivo stimulated with different inflammatory stimuli.
    9. The relationship of the nasal and gut microbiota on HRV-16 (re-)infection and vice-versa.
    1. De viral load in neusspoelingen
    2. De incubatie periode van HRV-16 infection
    3. De effecten van HRV-16 op verkoudheidssymptomen, temperatuur en spirometrie
    4. Inflammatoire parameters (en hun kinetiek) welke een rol spelen in de HRV-16 geïnduceerde lokale immunrespons
    5. Of HRV-16 infectie een systemische immuunrespons opwekt
    6. Het effect van HRV-16 seropositiviteit op de klinische en immunologische respons
    7. Of een proefpersoon beschermd is tegen HRV-16 re-infectie, en welke mechanismen hier een rol in spelen.
    8. Of HRV-16 infectie de immuunresponse van circulerende cytokines kan moduleren
    9. Het effect van HRV-16 infectie op neus en darm microbiota
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18 and ≤35
    - Healthy
    - Leeftijd ≥18 en ≤35
    - Gezond
    E.4Principal exclusion criteria
    - Pregnancy or lactating
    - Pre-existent lung disease, including asthma
    - A history of allergic rhinitis with positive allergen skin tests
    - Use of any medication
    - Use of nutritional supplements / probiotics
    - Use of alcohol > 5 units/day or >20 units/wk
    - Use of any drugs
    - Current smoker or more than 5 pack-year history
    - Frequently have nosebleeds
    - Recent nasal or otologic surgery
    - Febrile illness or a common cold within four weeks before the HRV challenge
    - Currently participating in another clinical trial
    - Borstvoeding of zwangerschap
    - Voorgeschiedenis van longziekten inclusief asthma
    - Voorgeschiedenis van allegische rhinitis met een positieve huid test
    - Gebruik van enige medicatie
    - Gebruik van voedingssupplementen of pro-biotica
    - Gebruik van alchol >5 eenheden per dag, of >20 eenheden per week
    - Gebruik van drugs
    - Roken of een voorgeschiedenis van >5 pakjaren
    - Frequente neusbloedingen
    - Recente nasale or otologische chirurgie
    - Koorts of verkoudheid in de 4 weken voorafgaand aan de HRV-blootstelling
    - momenteel deelnemen aan een andere klinische trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the infection rate (defined by a positive viral culture, qPCR and/or a four-fold rise in antibody titre) of healthy volunteers inoculated with a standardized dose of HRV-16.
    Het primaire eindpunt is de infectiegraad van gezonde vrijwilligers geïnioculeerd met een gestandaardiseerde dosis HRV-16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 0, days 2, and days 28
    dag 0, 2 en 28
    E.5.2Secondary end point(s)
    - Incubation period of HRV-16 infection.
    - Symptom scores measured by diary cards (WURSS 21 scoring method)
    - Temperature
    - Forced expiratory volume at a timed interval of 1 second (FEV1), and forced expiratory flow 25-75% (FEF 25-75%).
    - Leukocyte counts and differentiation (NK-cells, CD4 / CD8, neutrophils), and cytokine levels in nasal washes (including but not limited to IL-8, IL-1β, CCL5)
    - Leukocyte counts and circulating plasma cytokines (including but not limited to TNF-α, IL-6, IL-10, IFN-γ, IL-8, CCL5)
    - The cytokine response (including but not limited to TNF-α, IL-6, IL-10, IFN-γ), of leukocytes ex vivo stimulated with different stimuli (including but not limited to LPS, HRV, Staphylococcus aureus).
    - Composition of the nasal and gut microbiota
    - Incubatieperiode van HRV-16 infectie
    - Symptoomscores gemeten met dagboekkaarten (WURSS 21 methode)
    - Temperatuur
    - "Forced expiratory volume" na 1 seconde (FEV1) en "forced expiratory flow 25-75%" (FEF 25-75%).
    - witte bloedcel aantallen en differentiatie in neusspoelingen
    - witte bloedcel aantallen en circulerende plasma cytokines
    - De cytokine respons van witte bloedcellen ex vivo gestimuleerd met verschillende stimuli
    - Samenstelling van neus en darm microbiota
    E.5.2.1Timepoint(s) of evaluation of this end point
    days 0, 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 28
    dag 0, 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 28
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To set up the Human Rhinovirus (HRV)-model in our centre, using HRV serotype 16 (HRV-16).
    Om het menselijk rhinovirus model op te zetten in ons centrum, gebruik makend van HRV serotype 16 (HRV-16)
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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
    28 days after the last subject was inoculated with HRV-16 for the first time.
    28 dagen nadat de laatste vrijwilliger voor de eerste keer geinoculeerd werd met HRV-16
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    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: 40
    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 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 state40
    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 Decision2012-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-28
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