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    Clinical Trial Results:
    A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of VIS410 in Subjects with Uncomplicated Influenza A Infection

    Summary
    EudraCT number
    		 2015-004546-26
    Trial protocol
    		 BG   LV  
    Global end of trial date
    19 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2019
    First version publication date
    29 Aug 2019
    Other versions
    Summary report(s)
    		 VIS410-202 CT Results

    Trial information

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    Trial identification
    Sponsor protocol code
    VIS410-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Visterra, Inc.
    Sponsor organisation address
    275 2nd Avenue, 4th Floor, Waltham, MA, United States, 02451
    Public contact
    Kristi Schaefers , Visterra, Inc., 1 617-401-2019, kschaefers@visterra.com
    Scientific contact
    Kristi Schaefers , Visterra, Inc., 1 617-401-2019, kschaefers@visterra.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
    04 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the safety and tolerability of a single intravenous (IV) infusion of 2 dose levels of VIS410 in patients with uncomplicated influenza infection
    Protection of trial subjects
    An independent Data Safety Monitoring Board (DSMB) was established to review all available safety data after 30 subjects completed the Day 5 visit and again after 75 subjects completed the Day 28 visit. In addition, following the first DSMB, the DSMB was to convene in case of a drug related serious adverse event (SAE) or if the overall relative GI adverse event (AE) rate reached 50% or the rate of moderate GI AEs reached 25%.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Latvia: 15
    Country: Number of subjects enrolled
    United States: 58
    Country: Number of subjects enrolled
    South Africa: 73
    Worldwide total number of subjects
    150
    EEA total number of subjects
    19
    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)
    150
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was initiated in 58 study centers; 28 sites enrolled at least 1 subject.

    Pre-assignment
    Screening details
    		 When required, subjects may have been given a pre-screening informed consent in order to perform the Rapid Antigen Test for influenza. Flu-positive subjects were then given a full explanation of the nature of the study and written informed consent was obtained according to local requirements before any study-related assessment was carried out.

    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
    Blinding implementation details
    In order to maintain the blind, the site’s unblinded pharmacist or properly trained designee prepared the VIS410 or placebo dummy saline infusions according to the instructions in the Pharmacy Manual. The IV infusion bags were covered by an opaque sleeve in the pharmacy to protect the product from light and to maintain the study blind. Blinded site team was given the infusion bag with the opaque sleeve in place ready to be administrated to the subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VIS410 4000 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    VIS410 4000 mg
    Investigational medicinal product code
    VIS410
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution for infusion was administered as a single IV infusion over 2 hours

    Investigational medicinal product name
    VIS410 2000 mg
    Investigational medicinal product code
    VIS410
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution for infusion was administered as a single IV infusion over 2 hours

    Arm title
    		 VIS410 2000 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    VIS410 2000 mg
    Investigational medicinal product code
    VIS410
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution for infusion was administered as a single IV infusion over 2 hours

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    VIS410 4000 mg
    Investigational medicinal product code
    VIS410
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The site’s unblinded pharmacist or properly trained designee will prepare the VIS410 or placebo according to the instructions in the pharmacy manual. The required amount of VIS410 to be dosed (2000 mg or 4000 mg) will be diluted with normal saline up to a total volume of 200 mL. For placebo subjects, 200 mL of normal saline will be prepared.

    Investigational medicinal product name
    VIS410 2000 mg
    Investigational medicinal product code
    VIS410
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The site’s unblinded pharmacist or properly trained designee will prepare the VIS410 or placebo according to the instructions in the pharmacy manual. The required amount of VIS410 to be dosed (2000 mg or 4000 mg) will be diluted with normal saline up to a total volume of 200 mL. For placebo subjects, 200 mL of normal saline will be prepared.

    Investigational medicinal product name
    Placebo for VIS410
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The site’s unblinded pharmacist or properly trained designee will prepare the VIS410 or placebo according to the instructions in the pharmacy manual. The required amount of VIS410 to be dosed (2000 mg or 4000 mg) will be diluted with normal saline up to a total volume of 200 mL. For placebo subjects, 200 mL of normal saline will be prepared.

    Number of subjects in period 1
    		VIS410 4000 mg VIS410 2000 mg Placebo
    Started
    50
    50
    50
    Completed
    49
    48
    50
    Not completed
    1
    2
    0
         Consent withdrawn by subject
    -
    1
    -
         Lost to follow-up
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VIS410 4000 mg
    Reporting group description
    		 -

    Reporting group title
    VIS410 2000 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Total
    Number of subjects
    		 50 50 50 150
    Age categorical
    Adults (18-65)
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 50 50 50 150
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 27 29 28 84
        Male
    		 23 21 22 66
    Subject analysis sets

    Subject analysis set title
    Intent to Treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects randomized to treatment.

    Subject analysis set title
    Modified Intent to treat population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all ITT subjects who received IV study drug.

    Subject analysis set title
    Pharmacokinetic Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated.

    Subject analysis sets values
    		 Intent to Treat population Modified Intent to treat population Safety Population Pharmacokinetic Population
    Number of subjects
    150
    138
    148
    96
    Age categorical
    Adults (18-65)
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    150
    138
    148
    96
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    VIS410 4000 mg
    Reporting group description
    		 -

    Reporting group title
    VIS410 2000 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    Intent to Treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all subjects randomized to treatment.

    Subject analysis set title
    Modified Intent to treat population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all ITT subjects who received IV study drug.

    Subject analysis set title
    Pharmacokinetic Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated.

    Primary: Adverse events and adverse events of interest

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    End point title
    		 Adverse events and adverse events of interest [1]
    End point description
    • The proportion of subjects with AEs and SAEs following administration of VIS410 • The proportion of subjects with TEAEs including o Hypersensitivity reaction o Anaphylactic reaction o AEs of special interest (AESIs) following dosing
    End point type
    Primary
    End point timeframe
    3.3 months (100 ± 7 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: An overall summary of AEs, TEAEs, and adverse events of interest was presented by treatment group, including the combined low-dose and high-dose VIS410, and overall subjects, with subject counts, percentages, and the exact 95% CI for the percentage of subjects with the event.
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Safety Population
    Number of subjects analysed
    49
    49
    50
    148
    Units: Number of patients
        Subjects with any TEAE
    27
    17
    12
    58
        Subjects With Any Treatment-Related TEAE
    15
    7
    6
    28
        Subjects with any SAEs
    0
    0
    2
    2
        Subjects With Any Treatment-Related SAEs
    0
    0
    1
    1
        Subjects With Any TEAEs of Special Interest
    17
    8
    6
    31
        Hypersensitivity reaction
    0
    0
    0
    0
        Anaphylactic reaction
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: FluPRO Questionnaire Total Symptom Score

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    End point title
    		 FluPRO Questionnaire Total Symptom Score
    End point description
    FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group, including a combined low-dose and high-dose VIS410 group. This analysis was performed using the mITT population. The domain, component, and total symptom scores for an individual were calculated as the mean of the questions that were non-missing. Low mean scores indicate mild disease. The minimum data requirement for calculating each of the domain symptom scores was: nose 3 of 4 items, throat 2 of 3 items, eyes 2 of 3 items, chest/respiratory 5 of 7 items, GI 3 of 4 items, and body/systemic 8 of 11 items. Total symptom scores were calculated only if the conditions of missing data for all domains were met.
    End point type
    Secondary
    End point timeframe
    10 days
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    46
    44
    48
    138 [2]
    Units: Total Symptoms Score
    arithmetic mean (standard deviation)
        Percent change from baseline to Day 2
    -26.12 ( 27 )
    -29.98 ( 29.55 )
    -19.53 ( 26.51 )
    0 ( 0 )
        Percent change from baseline to Day 3
    -38.65 ( 28.78 )
    -49.37 ( 29.62 )
    -33.63 ( 23.6 )
    0 ( 0 )
        Percent change from baseline to Day 4
    -53.46 ( 26.16 )
    -59.08 ( 31.12 )
    -44.55 ( 28.2 )
    0 ( 0 )
        Percent change from baseline to Day 5
    -60.85 ( 25.52 )
    -64.61 ( 29.91 )
    -56.75 ( 24.31 )
    0 ( 0 )
        Percent change from baseline to Day 6
    -69.31 ( 20.90 )
    -66.8 ( 33.42 )
    -64.01 ( 23.35 )
    0 ( 0 )
        Percent change from baseline to Day 7
    -74.03 ( 19.31 )
    -70.76 ( 31.18 )
    -71.51 ( 20.61 )
    0 ( 0 )
        Percent change from baseline to Day 8
    -77.98 ( 20.76 )
    -76.03 ( 25.53 )
    -76.16 ( 21.01 )
    0 ( 0 )
        Percent change from baseline to Day 9
    -80.05 ( 19.78 )
    -78.48 ( 25.95 )
    -79.27 ( 22.91 )
    0 ( 0 )
        Percent change from baseline to Day 10
    -82.30 ( 20.07 )
    -81.38 ( 20.43 )
    -84.35 ( 17.52 )
    0 ( 0 )
    Notes
    [2] - Combined data not summarized
    Statistical analysis title
    		 Pt Diary - Influenza Pt Reported Outcomes (FluPRO)
    Statistical analysis description
    FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group, including a combined low-dose and high-dose VIS410 group. This analysis was performed using the mITT population. The domain, component, and total symptom scores for an individual were calculated as the mean of the questions that were non-missing. Low mean scores indicate mild disease. The minimum data requirement for calculating each of t
    Comparison groups
    VIS410 2000 mg v VIS410 4000 mg v Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.173
    Method
    		 Logrank
    Confidence interval

    Secondary: Hospitalization for influenza-related complications

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    End point title
    		 Hospitalization for influenza-related complications
    End point description
    • Percentage of participants requiring hospitalization for influenza-related complications
    End point type
    Secondary
    End point timeframe
    3.3 Months (100 ± 7 days)
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    46
    44
    48
    138
    Units: Percentage of participants requiring h
    number (not applicable)
        Hospitalized for influenzas-related complications
    0
    0
    2
    2
    No statistical analyses for this end point

    Secondary: Complications of influenza

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    End point title
    		 Complications of influenza
    End point description
    • Percentage of participants with complications of influenza
    End point type
    Secondary
    End point timeframe
    3.3 Months (100 ± 7 days)
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    46
    44
    48
    138
    Units: Percentage of participants with compli
    number (not applicable)
        influenzas-related complications
    1
    3
    3
    7
    No statistical analyses for this end point

    Secondary: Percentage of participants with influenza A relapse/reinfection

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    End point title
    		 Percentage of participants with influenza A relapse/reinfection
    End point description
    • Percentage of participants with influenza A relapse/reinfection
    End point type
    Secondary
    End point timeframe
    3.3 Months (100 ± 7 days)
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    46
    44
    48
    138
    Units: Percentage of participants with influenz
    number (not applicable)
        influenza A relapse
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: VIS410 PK parameters

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    End point title
    		 VIS410 PK parameters [3]
    End point description
    • VIS410 PK parameters (Cmax, time corresponding to maximum serum concentration [tmax], area under the concentration-time curve extrapolated to infinity [AUC0-∞], area under the concentration-time curve from time 0 to the last measurable concentration [AUC0-last], elimination half-life (t1/2), Volume of distribution [Vd]), and clearance (CL) in serum
    End point type
    Secondary
    End point timeframe
    3.3 Months (100 ± 7 days)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Standard non-compartmental approaches using Phoenix WinNonlin (Pharsight Corporation, Princeton, NJ, USA; Version 7.0 or higher) were used to estimate PK parameters.
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Modified Intent to treat population
    Number of subjects analysed
    47
    49
    96 [4]
    Units: Cmax, Tmax, AUC
    arithmetic mean (standard deviation)
        AUC 0 to infinity
    9157.319 ( 3209.0221 )
    5592 ( 1544.29 )
    0 ( 0 )
        AUC 0 to last
    24.722 ( 3250 )
    5624 ( 1619 )
    0 ( 0 )
        Cmax
    1066 ( 313 )
    729 ( 574 )
    0 ( 0 )
        T ½
    10.42 ( 2.35 )
    10.645 ( 3.35 )
    0 ( 0 )
        Clearance
    499.8 ( 211.659 )
    329.2 ( 124.8 )
    0 ( 0 )
        Tmax
    .210 ( .4873 )
    0.428 ( 1.28 )
    0 ( 0 )
        Volume of distribution
    7187 ( 2897 )
    5730 ( 1843 )
    0 ( 0 )
    Notes
    [4] - Totalk PK not calculated
    No statistical analyses for this end point

    Secondary: Viral load AUC

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    End point title
    		 Viral load AUC
    End point description
    • The difference between VIS410 and placebo treatment groups in viral AUC from nasopharyngeal swabs
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    46
    44
    48
    138
    Units: viral AUC from nasopharyngeal swabs
    arithmetic mean (standard deviation)
        Viral load AUC
    25.352 ( 7.4381 )
    25.856 ( 8.2532 )
    26.535 ( 7.8894 )
    25.914 ( 7.8602 )
    No statistical analyses for this end point

    Secondary: Peak viral load

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    End point title
    		 Peak viral load
    End point description
    • The difference between VIS410 and placebo treatment groups in peak VL from nasopharyngeal swabs
    End point type
    Secondary
    End point timeframe
    3.3 Months (100 ± 7 days)
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    50
    50
    50
    90 [5]
    Units: Peak VL from nasopharyngeal swabs
    arithmetic mean (standard deviation)
        Peak viral load
    6.686 ( 1.1195 )
    6.26 ( 1.0187 )
    6.713 ( 1.4354 )
    6.657 ( 1.0658 )
    Notes
    [5] - Total VIS410 group only (no data for placebo)
    Statistical analysis title
    		 Viral Load
    Statistical analysis description
    Standard non-compartmental approaches using Phoenix WinNonlin (Pharsight Corporation, Princeton, NJ, USA; Version 7.0 or higher) were used to calculate peak VL and VL AUC. The VL at each study visit, proportion of subjects with negative results at each study visit, peak VL, and VL AUC based on qRT-PCR and half-maximal tissue culture infective dose (TCID50) from nasopharyngeal secretions were summarized with n, mean, SD, geometric mean, CV, minimum and maximum values in the mITT population overal
    Comparison groups
    VIS410 4000 mg v VIS410 2000 mg v Placebo
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.795
    Method
    		 Phoenix WinNonlin
    Confidence interval

    Secondary: Resolution of viral load

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    End point title
    		 Resolution of viral load
    End point description
    • The difference between VIS410 and placebo treatment groups in time to resolution of VL from nasopharyngeal swabs
    End point type
    Secondary
    End point timeframe
    3.3 Months (100 ± 7 days)
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    46
    44
    48
    90
    Units: time to resolution of VL from swabs
    arithmetic mean (confidence interval 95%)
        Resolution of viral load (days)
    2.100 (1.79 to 3.77)
    1.870 (1.83 to 1.99)
    3.790 (1.83 to 3.900)
    1.9 (1.84 to 2.10)
    No statistical analyses for this end point

    Secondary: Antidrug Antibodies

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    End point title
    		 Antidrug Antibodies
    End point description
    • Titer of anti-VIS410 antibody-positive samples
    End point type
    Secondary
    End point timeframe
    100 days
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Placebo Modified Intent to treat population
    Number of subjects analysed
    49 [6]
    47 [7]
    47 [8]
    96 [9]
    Units: Anti-VIS410 antibody-positive samples
    arithmetic mean (standard deviation)
        Baseline Positive
    6 ( 12.2 )
    4 ( 8.5 )
    4 ( 8.5 )
    10 ( 10.4 )
        Baseline Negative
    43 ( 87.8 )
    43 ( 91.5 )
    43 ( 91.5 )
    86 ( 89.6 )
        Day 100 Positive
    20 ( 40.8 )
    22 ( 47.8 )
    6 ( 12 )
    42 ( 44.2 )
        Day 100 Negative
    29 ( 59.2 )
    24 ( 52.2 )
    44 ( 88 )
    53 ( 55.8 )
    Notes
    [6] - Values reported are n and %
    [7] - Values reported are n and %
    [8] - Values reported are n and %
    [9] - Values reported are n and % . Includes only pts receiving VIS410
    Statistical analysis title
    		 Antidrug Antibodies
    Statistical analysis description
    Anti-VIS410 antibody titer was summarized by treatment group and time point using descriptive statistics.
    Comparison groups
    VIS410 4000 mg v VIS410 2000 mg v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Phoenix WinNonlin
    Parameter type
    		 Phoenix Win non-lin
    Confidence interval

    Secondary: PK data from nasopharyngeal swab

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    End point title
    		 PK data from nasopharyngeal swab [10]
    End point description
    • PK parameters (Cmax, tmax, AUC0-∞, AUC0-last, t1/2, AUC ratio for nasopharyngeal: serum) of VIS410 from nasopharyngeal secretions
    End point type
    Secondary
    End point timeframe
    3.3 Months (100 ± 7 days)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Standard non-compartmental approaches using Phoenix WinNonlin (Pharsight Corporation, Princeton, NJ, USA; Version 7.0 or higher) were used to estimate PK parameters.
    End point values
    		 VIS410 4000 mg VIS410 2000 mg Modified Intent to treat population
    Number of subjects analysed
    47
    49
    96 [11]
    Units: PK parameters
    arithmetic mean (standard deviation)
        AUC 0 to infinity
    288.575 ( 254.0967 )
    186.133 ( 197.7161 )
    0 ( 0 )
        AUC 0 to last
    290.009 ( 235.2349 )
    144.878 ( 176.0992 )
    0 ( 0 )
        Cmax
    30.942 ( 22.3197 )
    15.157 ( 15.8274 )
    0 ( 0 )
        T ½
    9.97 ( 3.033 )
    10.201 ( 3.5959 )
    0 ( 0 )
        Nasal to serum ratio Day 3 to infinity
    3.77 ( 2.8818 )
    2.761 ( 2.2756 )
    0 ( 0 )
        Tmax
    3.445 ( 1.9168 )
    3.212 ( 3.0468 )
    0 ( 0 )
    Notes
    [11] - Data not collected for combined groups
    No statistical analyses for this end point

    Secondary: Duration of Hospitalization for influenza related complications

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    End point title
    		 Duration of Hospitalization for influenza related complications
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Modified Intent to treat population
    Number of subjects analysed
    138
    Units: day
        number (not applicable)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3.3 Months (100 ± 7 days)
    Adverse event reporting additional description
    • The proportion of subjects with AEs and SAEs following administration of VIS410 • The proportion of subjects with TEAEs including o Hypersensitivity reaction o Anaphylactic reaction o AEs of special interest (AESIs) following dosing
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    VIS410 4000 mg
    Reporting group description
    		 All patients who received treatment

    Reporting group title
    VIS410 2000 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 VIS410 4000 mg VIS410 2000 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    2 / 50 (4.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Cerebrovascular accident
    Additional description: No action was taken with regard to the study drug because of this event.
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
    Additional description: No action was taken with regard to the study drug because of these events.
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 VIS410 4000 mg VIS410 2000 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 49 (100.00%)
    49 / 49 (100.00%)
    48 / 50 (96.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 49 (4.08%)
    2 / 50 (4.00%)
         occurrences all number
    3
    2
    2
    General disorders and administration site conditions
    Number of Subjects with any TEAE
         subjects affected / exposed
    27 / 49 (55.10%)
    17 / 49 (34.69%)
    12 / 50 (24.00%)
         occurrences all number
    27
    17
    12
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    13 / 49 (26.53%)
    8 / 49 (16.33%)
    6 / 50 (12.00%)
         occurrences all number
    13
    8
    6
    Vomiting
         subjects affected / exposed
    4 / 49 (8.16%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    4
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2016
    All countries- Modified safety assessments, clinical doses, and pretreatment regimens
    12 Oct 2016
    South Africa specific- Inclusion of HIV testing at Baseline
    15 Nov 2016
    Latvia specific- Revised to address VHP GNA comments of 7 November 2016
    14 Mar 2017
    South Africa specific- Modification of HIV exclusion criteria #12

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Jun 2017
    The Study was put on halt for one day and a half, the timeframe DSMB needed to meet with urgency and decide if it was safe to continue with the Study after evaluating SAE for patient 80811. Unfortunately, patient 80716 was being randomized at the time of the halt, and it was decided not to dose this patient since it couldn’t be done without DSMB meeting outcome. DSMB concluded that the study recruitment could be resumed, and study could continue as per study protocol. However, it was late for patient 80716 that couldn’t be dosed as it was outside the protocol allowed window.
    29 Jun 2017

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In this study, VIS410 therapy did not appear to reduce the ability to elaborate an antibody response to influenza A virus as anti-influenza A antibody titers were similar to that of the placebo group.
    For support, Contact us.
    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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