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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2015-002895-26
    Trial protocol
    		 GB  
    Global end of trial date
    14 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2018
    First version publication date
    15 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PrEP-CS-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    hVIVO Services Limited
    Sponsor organisation address
    QMB Innovation Centre, 42 New Road, London, United Kingdom, E1 2AX
    Public contact
    Regulatory Affairs, hVIVO Services Limited, regsubmissions@hvivo.com
    Scientific contact
    Regulatory Affairs, hVIVO Services Limited, regsubmissions@hvivo.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was 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.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    66
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were healthy males and/or females, 18 to 55 years of age, who met the eligibility criteria outlined in the Protocol.

    Pre-assignment period milestones
    Number of subjects started
    		 66
    Number of subjects completed
    		 66

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Cohort A: Cohort A was open label. No randomisation was applied. All Subjects received virus inoculum only on Day 0. Cohort B: PrEP-001 and placebo treatment arms were double blinded and randomised 1:1.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort B: PrEP-001
    Arm description
    		 PrEP-001
    Arm type
    		 Experimental

    Investigational medicinal product name
    PrEP-001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    6400 μg micrograms per day (4 x 800μg per nostril), equally divided over both nostrils (powder).

    Arm title
    		 Cohort B: Placebo
    Arm description
    		 Placebo to PrEP-001
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to PrEP-001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    Other than active ingredient it is identical to PrEP-001.

    Arm title
    		 Cohort A: Sentinel group
    Arm description
    		 Challenge Virus Only. No IMP.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Cohort B: PrEP-001 Cohort B: Placebo Cohort A: Sentinel group
    Started
    27
    28
    11
    Completed
    25
    27
    11
    Not completed
    2
    1
    0
         Abnormal lab finding
    1
    1
    -
         Physician decision
    1
    -
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Cohort B: PrEP-001
    Reporting group description
    		 PrEP-001

    Reporting group title
    Cohort B: Placebo
    Reporting group description
    		 Placebo to PrEP-001

    Reporting group title
    Cohort A: Sentinel group
    Reporting group description
    		 Challenge Virus Only. No IMP.

    Primary: Area under the curve (AUC) of total symptom score Day 1

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    End point title
    		 Area under the curve (AUC) of total symptom score Day 1
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint was the area under the curve (AUC) of total symptom score Day 1 (post viral challenge) to Day 8 (quarantine discharge).
    End point values
    		 Cohort B: PrEP-001 Cohort B: Placebo Cohort A: Sentinel group
    Number of subjects analysed
    25
    27
    11
    Units: mins*score
        arithmetic mean (standard deviation)
    4502.6 ± 6144.84
    9859.6 ± 12215.84
    17956.5 ± 23780.83
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    Continuous variables was summarised using number of observations, mean, standard deviation, median, lower quartile, upper quartile, minimum and maximum values. Categorical variables was summarised using proportions (counts and percentages).
    Comparison groups
    Cohort B: Placebo v Cohort B: PrEP-001
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.05 [2]
    Method
    		 No formal method.
    Confidence interval
    Notes
    [1] - Descriptive statistics
    [2] - No formal statistics was performed, the p-value that is included in the above box is irrelevant

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Collected from informed consent until final follow up visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Overall safety population
    Reporting group description
    		 -

    Serious adverse events
    		 Overall safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 66 (72.73%)
    Investigations
    Alanine aminotransferase increased
    Additional description: For occurrences all number 14 is the minimum value.
         subjects affected / exposed
    14 / 66 (21.21%)
         occurrences all number
    14
    Aspartate aminotransferase increased
    Additional description: For occurrences all number 11 is the minimum value
         subjects affected / exposed
    11 / 66 (16.67%)
         occurrences all number
    11
    Blood cholesterol increased
    Additional description: For occurrences all number 8 is the minimum value
         subjects affected / exposed
    8 / 66 (12.12%)
         occurrences all number
    8
    Activated partial thromboplastin time prolonged
    Additional description: For occurrences all number 6 is the minimum value
         subjects affected / exposed
    6 / 66 (9.09%)
         occurrences all number
    6
    Low density lipoprotein increased
    Additional description: For occurrences all number 5 is the minimum value
         subjects affected / exposed
    5 / 66 (7.58%)
         occurrences all number
    5
    C-reactive protein increased
    Additional description: For occurrences all number 4 is the minimum value
         subjects affected / exposed
    4 / 66 (6.06%)
         occurrences all number
    4
    Lipase increased
    Additional description: For occurrences all number 4 is the minimum value
         subjects affected / exposed
    4 / 66 (6.06%)
         occurrences all number
    4
    Blood fibrinogen increased
    Additional description: For occurrences all number 3 is the minimum value
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Blood triglycerides increased
    Additional description: For occurrences all number 3 is the minimum value
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Neutrophil count decreased
    Additional description: For occurrences all number 3 is the minimum value
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    White blood cell count increased
    Additional description: For occurrences all number 2 is the minimum value
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Procedural haemorrhage
    Additional description: For occurrences all number 17 is the minimum value
         subjects affected / exposed
    17 / 66 (25.76%)
         occurrences all number
    17
    Skin abrasion
    Additional description: For occurrences all number 2 is the minimum value
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Nervous system disorders
    Headache
    Additional description: For occurrences all number 5 is the minimum value
         subjects affected / exposed
    5 / 66 (7.58%)
         occurrences all number
    5
    General disorders and administration site conditions
    Pyrexia
    Additional description: For occurrences all number 2 is the minimum value. The adverse event of pyrexia for one of these two subjects was reviewed post database lock and determined to be a symptom rather than an AE (the database was not changed).
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Infections and infestations
    Viral upper respiratory tract infection
    Additional description: For occurrences all number 3 is the minimum value
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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