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    Summary
    EudraCT Number:2018-004015-49
    Sponsor's Protocol Code Number:FLU010
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-004015-49
    A.3Full title of the trial
    Efficacy of MVA-NP+M1 in the influenza H3N2 Human Challenge model
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    na
    A.4.1Sponsor's protocol code numberFLU010
    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 SponsorVaccitech Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVaccitech Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVaccitech Ltd
    B.5.2Functional name of contact pointDalila Karbiche
    B.5.3 Address:
    B.5.3.1Street AddressThe Schrödinger Building, 2nd Floor, Heatley Road,The Oxford Science Park
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX4 4GE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number +44(0)1865 818 808
    B.5.6E-mailDalila.Karbiche@vaccitech.co.uk
    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 nameMVA-NP+M1
    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 INNna
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codeMVA-NP+M1
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5x10^8
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    influenza disease
    E.1.1.1Medical condition in easily understood language
    flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to show that MVA-NP+M1 decreases the viral shedding of influenza virus, as measured by the cumulative area under the curve, following human challenge.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to show safety, the effect on the incidence of laboratory-confirmed influenza-like illness (ILI), total and individual symptom scores, and mucous production (measured by tissue weight). Immune T cell responses and correlation of these responses with efficacy will also be investigated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment.
    2. Non-smokers or those who stopped smoking ≥ 3 months prior to screening 1 visit.
    3. Willingness to remain in isolation for the duration of the study.
    4. A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
    a. Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
    b. Of childbearing potential but agrees to practice effective contraception or abstinence from 4 weeks prior to vaccination to 8 weeks after administration of the influenza challenge virus. Acceptable methods of contraception include 1 or more of the following:
    i. male partner who is sterile prior to the female participants entry into the study and is the sole sexual partner for the female participant;
    ii. implants of levonorgestrel;
    iii. injectable progestogen;
    iv. an intrauterine device with a documented failure rate of < 1%;
    v. oral contraceptives.
    5. Pre-challenge serum microneutralization (MNT) against A/Belgium/4217/2015 (H3N2) challenge strain ≤ 10.
    E.4Principal exclusion criteria
    1. Body Mass Index (BMI) < 19 and > 32.
    2. Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness including a history of chronic respiratory illness.
    3. History of seasonal hay fever or a seasonal allergic rhinitis (SAR), including the use of symptomatic prescription only medication and non-prescription medication.
    4. History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic dermatitis/eczema and atopic rhinitis.
    5. Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine.
    6. History of lung disease (Asthma, COPD).
    7. Current smokers or those who stopped smoking < 3months prior to screening 1 visit.
    8. Positive diagnostic tests for HIV, Hepatitis B or Hepatitis C indicating active infection.
    9. Evidence of drug abuse or a positive urine drug screen or alcohol breath test.
    10. Acute use of any medication or other product, prescription or over-the-counter, for symptoms of rhinitis or nasal congestion within 7 days prior to challenge. This includes any corticosteroid or beta agonist containing nasal spray.
    11. Chronic use of any medication or other product (prescription or over-the-counter), for symptoms of rhinitis or nasal congestion or for any chronic nasopharyngeal complaint, or chronic use of any intranasal medication for any indication that has not cessed within 30 days prior to screening 1.
    12. Receipt of any investigational drug within 3 months prior to vaccination, or prior participation in a clinical trial of any influenza vaccine, or any investigational vaccine or experimental influenza viral challenge delivered directly to the respiratory tract within 1 year prior to challenge.
    13. Receipt of the 2018/2019 seasonal flu vaccine.
    14. Receipt of any live vaccines within the 4 weeks prior to vaccination.
    15. Any laboratory test which is abnormal and which is deemed by the Investigator(s) to be clinically significant.
    16. Receipt of any systemic chemotherapy agent at any time.
    17. Physician reported influenza or a syndrome consistent with influenza (as judged by the investigator) in the previous 6 months.
    18. Presence of fever, defined as subject presenting with a temperature reading of > 38.0°C on admission to quarantine.
    19. Known close contact with anyone known to have influenza in the past 7 days at the time of quarantine.
    20. Known allergy to treatments for influenza (including but not limited to oseltamivir).
    21. History of frequent epistaxis (nose bleeds).
    22. Any nasal or sinus surgery within 6 months of Viral Challenge or any significant abnormality, either of which results in alteration of the anatomy of the nose or nasopharynx (including significant nasal polyps).
    23. Volunteers with household contacts who are at risk for serious or severe complications of influenza disease including, but not limited to, persons > 65 years, presence of significant chronic cardiopulmonary, metabolic, renal, or neurological conditions, immunosuppression due to any condition or therapies, or BMI >40.
    24. Subjects that are an employee or family member of the Investigator or study site personnel may not be enrolled.
    25. Any other finding that, in the opinion of the Investigator, deems the subject unsuitable for the study
    Exclusion (Challenge Period only)
    1. Abnormal spirometry assessed to be clinically significant.
    2. Known close contact with anyone known to have influenza in the past 7 days at the time of quarantine.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Total viral area under the curve (vAUC) for virologic shedding as measured by quantitative PCR (qPCR) for MVA-NP+M1 vs. Placebo groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout the trial
    E.5.2Secondary end point(s)
    - Incidence in each group (MVA-NP+M1 and saline Placebo) of laboratory-confirmed ILI (qPCR or culture).
    - Total AUC for total symptom score (regardless of take rate) for MVA vs. Placebo
    - Total days of fever for MVA-NP+M1 vs. Placebo
    - Total mucus weight (regardless of take rate) for MVA vs. Placebo
    - Correlation of T cell responses (as defined by ELISpot assay) to the primary endpoint, symptom scores, and influenza incidence
    - The attack rate, defined as percentage of inoculated subjects with at least two consecutive positive swabs as determined by qPCR

    Safety
    - Frequency and severity of patient-recorded local and systemic adverse events recorded for the 7 days following vaccination
    - Frequency and severity of non-solicited adverse events captured throughout the study after vaccination
    - Frequency and types of serious adverse events
    - Severity of adverse events in each study group following intranasal challenge with H3N2
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the trial
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Proof of concept
    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 years1
    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: 155
    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 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 state155
    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)
    see protocol
    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 Decision2019-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-07
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