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    Summary
    EudraCT Number:2020-004137-21
    Sponsor's Protocol Code Number:78591.041.21
    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:2021-08-14
    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 number2020-004137-21
    A.3Full title of the trial
    Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection – a human challenge study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nasal administration of palivizumab in an RSV human challenge model
    A.3.2Name or abbreviated title of the trial where available
    CHIMP
    A.4.1Sponsor's protocol code number78591.041.21
    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 SponsorUniversity Medical Center Utrecht
    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 supportUniversity Medical Center Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointnarsyn trial information
    B.5.3 Address:
    B.5.3.1Street AddressLundlaan 6
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584EA
    B.5.3.4CountryNetherlands
    B.5.6E-mailchimp@umcutrecht.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 nameCommercial Synagis
    D.3.4Pharmaceutical form Nasal drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal drops
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    respiratory syncytial virus infection
    E.1.1.1Medical condition in easily understood language
    respiratory syncytial virus infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study A:
    Productive RSV infection (defined as positive viral detections by PCR assay on 2 consecutive sampling points during the quarantine, post RSV inoculation measured on day 2 onwards).
    Study B will start if there is productive infection in at least 1/6 volunteers in Study A

    Study B:
    Area under the curve (AUC) for viral load as determined by quantitative PCR from a daily nasal-wash sample from day 2 to day 14 similar to previous studies.
    E.2.2Secondary objectives of the trial
    Study A:
    1. To understand transmission by performing RSV PCR on nasal samples from study personnel and fomites (faucet, handle to flush toilet, doorknob and light switch) before and after wiping these surfaces with alcohol on day 7 post inoculation [(nasal) swabs]
    2. Safety measured by self-reported and physician-reported local and systemic adverse events and severe RSV disease defined as lower respiratory tract infection with PCR-confirmed RSV that requires hospitalization or ICU admission.
    Other: Leukocyte characterization, cytokines & chemokine profiles, RSV microneutralization, lung function over time, safety, adverse events, symptom profile.

    Study B:
    1. Local and systemic safety of IN palivizumab
    2. PK & PD of palivizumab
    3. To measure anti-drug antibodies (ADA's) to palivizumab
    Other: Leukocyte characterization, cytokines & chemokine profiles, RSV microneutralization, lung function over time, safety, adverse events, symptom profile.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy males or females
    2. Age 18-55 years
    3. Signed and dated informed consent form
    E.4Principal exclusion criteria
    1. Child < 3 years old living in subject’s household
    2. Person > 65 years old or significant primary or secondary immunodeficiency living in subject’s household
    3. Presence of significant acute or chronic medical illness that is associated with increased risk of respiratory viral illness related complications. These include but are not limited to:
    a. Recent (within adulthood) history of asthma, chronic obstructive pulmonary disease (COPD), hypertension, reactive airway disease, or any other chronic lung illness
    b. History or evidence of impaired immune responsivity or autoimmune disease
    c. Confirmed hepatitis B (HBV), human immunodeficiency virus (HIV), or hepatitis C (HCV) infection
    4. Adults with a nasal cold or obstructions which could interfere with administration of the study intervention
    5. Simultaneous use of other nasal drops, sprays, or medications
    6. Nasal surgery prior to or during the trial
    7. COVID-19 infection 48 hours before study start
    8. Pregnancy
    9. Symptoms of clear nasal congestion
    E.5 End points
    E.5.1Primary end point(s)
    Study A: The primary endpoint is the percent of patients with productive infection (defined by 2 positive viral detections by PCR assay on 2 consecutive sampling points during quarantine, post RSV inoculation measured from day 2 onwards)

    Study B: The primary endpoint is the AUC viral load as measured by the qRT-PCR assay from viral load measurement from day 2 through day 14. This analysis will be performed to test the null hypothesis that there is no difference between the Narsyn (IMP) and placebo treatment groups in the mean AUC viral load. For the primary analysis, a mixed-effects model with a repeated-measures approach will be implemented to allow for unequal variances.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation occurs from day 0-10 and follow up through day 28
    E.5.2Secondary end point(s)
    Study A:
    We will use a longitudinal mixed effect model to analyze the repeated measurements which can be considered a continuous outcome measure. We will fit a random intercept per participant to take the correlation within subjects into account. We will add time as a categorical variable (dummy coding) as the number of time points is limited. From this model, we can estimate the mean (95% CI) at every time point and calculate the area under the curve over time for each subject and the overall group.

    Study B:
    Quantitative assessments of symptom scores, lung function, viral load (AUC), leukocyte numbers and inflammatory markers will be compared between study arms. These measures will be generated using descriptive statistics (sample size, mean, standard deviation, median, Q1, Q2, minimum and maximum). Dosing regimens were individually compared with the pooled placebo group, and all comparisons were two-sided, with the level of significance set at 0.05. Differences will be analyzed using two-tailed t-tests or Wilcoxon signed rank test as appropriate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow up for human experimental model efficacy, definition of local and systemic safety of intranasal administration of palivizumab, pharmacokinetics and pharmacodynamics of palivizumab after intranasal administration, immunogenicity of preventative antibodies, and the determination of the half life of palivizumab occurs from day 0 to 10 and follow up occurs from day 11 to 28
    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 Yes
    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 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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 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
    LVLS
    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 months6
    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: 34
    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 state34
    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)
    If phase IIB shows efficacy we will move to a phase III trial so that the product can be registered so access is guaranteed in the pediatric population, since the trial population is not the target population for the drug. Otherwise, no special treatment after the end of trial participation other than standard medical care is guaranteed.
    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 Decision2021-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-11
    P. End of Trial
    P.End of Trial StatusOngoing
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