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    Summary
    EudraCT Number:2015-002895-26
    Sponsor's Protocol Code Number:PrEP-CS-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-002895-26
    A.3Full title of the trial
    A Phase II, Repeated Dose, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Healthy Subjects Subsequently Challenged with Influenza A/Perth/16/2009(H3N2) Virus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influenza A/Perth/16/2009(H3N2) Virus challenge study of PrEP-001 in Healthy Volunteers
    A.4.1Sponsor's protocol code numberPrEP-CS-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 SponsorhVIVO Services Limited
    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 supporthVIVO Services Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportPrEP Biopharm
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen Research & Development
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationhVIVO Services Limited
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressQueen Mary BioEnterprises Innovation Centre, 42 New Road
    B.5.3.2Town/ cityWhitechapel/London
    B.5.3.3Post codeE1 2AX
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailregsubmissions@hvivo.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.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePrEP-001 (JNJ-43260295-AAM)
    D.3.4Pharmaceutical form Nasal powder
    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 INNNA
    D.3.9.1CAS number 42424-50-0
    D.3.9.2Current sponsor codeJNJ-43260295-AAM
    D.3.9.3Other descriptive nameJNJ-43260295, Product Number WO643, Poly IC, Poly I: Poly C
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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 powder
    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
    Influenza A/Perth/16/2009(H3N2) Virus
    E.1.1.1Medical condition in easily understood language
    Influenza
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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
    The primary objective of the study is to assess the prophylactic effect of repeated intranasal dosing of PrEP-001 in healthy subjects subsequently challenged with Influenza A/Perth/16/2009 (H3N2) Virus on the incidence of laboratory-confirmed Influenza illness when compared to placebo.
    E.2.2Secondary objectives of the trial
    To determine the prophylactic effect of PrEP-001 after repeated nasal dosing in healthy subjects subsequently challenged with Influenza A/Perth/16/2009(H3N2) Virus, on clinical signs and symptoms of Influenza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (IMP).
    In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation. A subject with a history of Herpes type 1 or 2 infection may be included if there are no active lesions present and the subject is not taking active medication.
    A documented medical history for a minimum of the last 2 years prior to entry into the study.
    A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2. If the BMI is more than 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
    The following inclusion criteria are applicable to subjects in a heterosexual relationship (i.e., the criteria do not apply to those in a same sex relationship):
    - True abstinence - when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
    Female study subjects who are not heterosexually active must have periodic confirmation of continued abstinence from heterosexual intercourse
    Or
    - Two forms of effective contraceptive methods among (between) the couple, which are defined as:
    For males:
    i. Condom with spermicidal foam/gel/film/cream, sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. This applies only to males participating in the study).
    For females:
    i. Women who are not of child bearing potential i.e., women who are (post-menopausal [having a history of amenorrhea for at least 2 years], or have documented status as being surgically sterile,[have had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation, as confirmed by the General Practitioner (GP), or are otherwise incapable of becoming pregnant], must use a condom when having heterosexual intercourse from screening until 90 days after receiving the study drug. (The latter applies only to females participating in the study).
    ii. If of childbearing potential, acceptable forms of contraception include:
    Established (a minimum of 2 weeks prior to admission) use of oral, injected or implanted hormonal methods of contraception.
    - Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    - Barrier methods of contraception or occlusive cap (diaphragm or cervical/vault caps), both with one of the following - spermicidal foam/gel/film/cream/suppository.
    The longevity of contraception is as follows:
    i. Male subjects must comply with agreed contraception at entry to quarantine, and continuing until 90 days after the date of Viral Challenge.
    ii. Male subjects must not donate sperm following discharge from quarantine until 90 days after the date of Viral Challenge
    iii. Female subjects of childbearing potential must have a negative pregnancy test at screening and just prior to the date of first dosing with IMP and must be using contraception consisting of two forms of birth control (one of which must be a barrier method) starting from14 days prior to entry to quarantine and continuing until 90 days after the date of Viral Challenge.
    An informed consent document signed and dated by the subject and the Investigator.
    Sero-suitable for the Challenge Virus.
    A history of childhood asthma before the age of 12 years is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing (lasting less than 8 weeks) after age 12 years can be included at the Investigator's discretion provided the episode was more than 4 years ago and did not require a hospital admission and/or oral/intravenous steroids.
    All documents containing GP history have been checked to confirm eligibility.
    E.4Principal exclusion criteria
    1.Subjects who have a significant history of any tobacco use at any time (total ≥ 10 pack year history [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years]
    2.Females who:Are breastfeeding, or Have been pregnant within 6 months prior to the study, or Have a positive pregnancy test at any point during screening or prior to first dosing with IMP.
    3.Any history or evidence of any clinically significant cardiovascular, dermatological (including psoriasis), gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study.
    4.Abnormal pulmonary function in the opinion of the Investigator as evidenced by the responses to the respiratory screening questions and/or clinically significant abnormalities in spirometry (FEV1 and FVC).
    5. History or evidence of autoimmune disease or known immunodeficiency of any cause – with the exception of atopic eczema/atopic dermatitis as described in exclusion criteria number (3).
    6. Subjects with any history of COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (see inclusion criteria number [8] for asthma).
    7.Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.
    8. Any significant abnormality altering the anatomy of the nose or nasopharynx.
    9. Any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or History of being hospitalized due to epistaxis on any previous occasion.
    10. Any nasal or sinus surgery within 6 months of Viral Challenge.
    11.Recurrent history of fainting.
    12.Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the Investigator, where available using information from a central reader.
    13. Confirmed positive test for drugs of abuse deemed by the Investigator to be clinically significant
    14.Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
    15.Any clinically significant allergies such as allergy to the excipients in the Challenge Virus inoculum, PrEP-001 (cohort B only) or Placebo formulations (Cohort B only) as stipulated in the protocol.
    16. Evidence of vaccinations within the 4 weeks prior to the planned date of first dosing with IMP or intention to receive any vaccination(s) before the last day of Follow-up. (NB. No travel restrictions will apply after the Day 28 Follow-up visit).
    17. Those employed or immediate relatives of those employed at hVIVO
    18. Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood during the 3 months prior to the planned date of first dosing with IMP or planned during the 3 months after the final visit.
    19. Use within 7 days prior to the planned date of first dosing with IMP of any medication or product (prescription or over-the-counter), for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infections including the use of nasal steroids.
    20. Receipt of any investigational drug within 3 months prior to the planned date of first dosing with IMP. Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of first dosing with IMP. Prior inoculation with a virus from the same virus-family as the Challenge Virus.
    Prior participation in another Human Viral Challenge study with a respiratory virus in the preceding 12 months, taken from the date of first dosing with IMP in the previous study to the date of expected Viral Challenge in this study.
    21. Receipt of systemic (intravenous and/or oral) glucocorticoids or systemic antiviral drugs within 6 months prior to the planned date of first dosing with IMP.
    22. History suggestive of respiratory infection within 14 days prior to admission to the Quarantine Unit or Presence of significant respiratory symptoms on the day of first dosing with IMP.
    23. Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows
    24. Any other finding that, in the opinion of the Investigator, deems the subject unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    AUC of total symptom score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Day 28 (+/- 5 Days)
    E.5.2Secondary end point(s)
    - Symptom scores
    - Incidence(s) of illness and infection
    - Viral load parameters (using TCID50 and/or qPCR)
    -Seroconversion/seroprotection as calculated by a ratio of Influenza A/Perth/16/2009 (H3N2) Virus antibodies at follow-up versus pre-dose.
    - Total weight of mucus produced.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to Day 28 (+/- 5 Days)
    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 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
    Tolerability
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 70
    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 state70
    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)
    There is no planned post trial treatment as all subjects are healthy population.
    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 Decision2015-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-14
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