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    Clinical Trial Results:
    Exploring novel mechanisms of vaccine failure and induction of pulmonary immunity following live attenuated influenza vaccination in HIV infected and uninfected individuals: a pilot study.

    Summary
    EudraCT number
    		 2014-001924-31
    Trial protocol
    		 GB  
    Global end of trial date
    15 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions
    Summary report(s)
    		 Primary Endpoint Data

    Trial information

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    Trial identification
    Sponsor protocol code
    STH18166
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02266992
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    Trust Headquarters, 8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    Scientific contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    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
    15 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Do HIV infected individuals have distinct differential early gene expression profiles following intra-nasal live attenuated influenza vaccine, when compared to age and sex matched HIV negative subjects, thus providing insights into the aberrant immunological response to live vaccines modulated by HIV infection?
    Protection of trial subjects
    All participants were given a participant information sheet to read and consider for at least 24 hours before attending for a screening visit for the study. Participants were reviewed by a clinician, or an experienced study nurse who was delegated to this task, according to the strict inclusion and exclusion criteria. All participants give written informed consent prior to enrolment to the study
    Background therapy
    		 Nil therapy
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    05 Sep 2014
    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: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Two groups: HIV-uninfected subjects and HIV-infected subjects. Recruited from Sheffield, UK. Recruitment period: 05/09/2014 - 31/10/2015

    Pre-assignment
    Screening details
    		 HIV infected subjects, on antiretroviral therapy were screened in accordance with the eligibility criteria. HIV-negative subjects were screened in accordance with eligibility criteria. They must have had history of having received at least one dose of trivalent inactivated influenza vaccine in the past and be a Non-smoker All were 18 – 49

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Trial was not blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HIV Infected Participants
    Arm description
    		 HIV Infected Participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    FLUENZ tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
    Investigational medicinal product code
    EMEA/H/C/002617 (European Medicines Agency code)
    Other name
    FLUENZ tetra nasal spray suspension
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    One dose (0.1ml divided dose into each nostril)

    Arm title
    		 HIV not infected participants
    Arm description
    		 HIV not infected participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    FLUENZ tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
    Investigational medicinal product code
    EMEA/H/C/002617 (European Medicines Agency code)
    Other name
    FLUENZ tetra nasal spray suspension
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    One dose (0.1ml divided dose into each nostril)

    Number of subjects in period 1
    		HIV Infected Participants HIV not infected participants
    Started
    8
    20
    Day 3
    7
    20
    Day 7
    6
    20
    Completed
    4
    19
    Not completed
    4
    1
         Lost to follow-up
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HIV Infected Participants
    Reporting group description
    		 HIV Infected Participants

    Reporting group title
    HIV not infected participants
    Reporting group description
    		 HIV not infected participants

    Reporting group values
    		 HIV Infected Participants HIV not infected participants Total
    Number of subjects
    		 8 20 28
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 8 20 28
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 10 14
        Male
    		 4 10 14

    End points

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    End points reporting groups
    Reporting group title
    HIV Infected Participants
    Reporting group description
    		 HIV Infected Participants

    Reporting group title
    HIV not infected participants
    Reporting group description
    		 HIV not infected participants

    Primary: Antiinfluenza antibody titres in serum - H1N1

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    End point title
    		 Antiinfluenza antibody titres in serum - H1N1 [1]
    End point description
    Antiinfluenza antibody titres in serum
    End point type
    Primary
    End point timeframe
    median fold rise in antibody titre from day 0 to day 28 post-vaccination, per influenza antigen included in the vaccine - H1N1
    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: Hypothesis testing was not relevant to the study objectives. Please note that this is a secondary endpoint, not a primary end point as stated. Unable to submit EudraCT form without a primary end point inputted. See attachment for primary endpoint data.
    End point values
    		 HIV Infected Participants HIV not infected participants
    Number of subjects analysed
    4
    19
    Units: haemagglutinating units
        median (inter-quartile range (Q1-Q3))
    1 (1 to 1.25)
    1 (1 to 1)
    No statistical analyses for this end point

    Primary: Antiinfluenza antibody titres in serum - H3N2

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    End point title
    		 Antiinfluenza antibody titres in serum - H3N2 [2]
    End point description
    Antiinfluenza antibody titres in serum
    End point type
    Primary
    End point timeframe
    median fold rise in antibody titre from day 0 to day 28 post-vaccination, per influenza antigen included in the vaccine - H3N2
    Notes
    [2] - 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: Hypothesis testing was not relevant to the study objectives. Please note that this is a secondary endpoint, not a primary end point as stated. Unable to submit EudraCT form without a primary end point inputted. See attachment for primary endpoint data.
    End point values
    		 HIV Infected Participants HIV not infected participants
    Number of subjects analysed
    4
    19
    Units: haemagglutinating units
        median (inter-quartile range (Q1-Q3))
    1 (1 to 1)
    1 (1 to 1)
    No statistical analyses for this end point

    Primary: Antiinfluenza antibody titres in serum - Influenza B

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    End point title
    		 Antiinfluenza antibody titres in serum - Influenza B [3]
    End point description
    Antiinfluenza antibody titres in serum
    End point type
    Primary
    End point timeframe
    median fold rise in antibody titre from day 0 to day 28 post-vaccination, per influenza antigen included in the vaccine - Influenza B
    Notes
    [3] - 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: Hypothesis testing was not relevant to the study objectives. Please note that this is a secondary endpoint, not a primary end point as stated. Unable to submit EudraCT form without a primary end point inputted. See attachment for primary endpoint data.
    End point values
    		 HIV Infected Participants HIV not infected participants
    Number of subjects analysed
    4
    19
    Units: haemagglutinating units
        median (inter-quartile range (Q1-Q3))
    1 (1 to 1)
    1 (1 to 1.25)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The reporting period for adverse events was be from the date informed consent is signed until 28 days after administration of IMP.
    Adverse event reporting additional description
    Subjects were asked about the appearance of any potential adverse effects on day 3 and 7 following LAIV administration. No SAEs occured in this trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    HIV Infected Participants
    Reporting group description
    		 HIV Infected Participants

    Reporting group title
    HIV not infected participants
    Reporting group description
    		 HIV not infected participants

    Serious adverse events
    		 HIV Infected Participants HIV not infected participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HIV Infected Participants HIV not infected participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    12 / 20 (60.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 20 (20.00%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Eye disorders
    Itchy eyes
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Swollen eyelid
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 8 (0.00%)
    7 / 20 (35.00%)
         occurrences all number
    0
    8
    Runny nose
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    Sore throat
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 20 (20.00%)
         occurrences all number
    0
    4
    Musculoskeletal and connective tissue disorders
    Generalised Muscle Aches
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    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.
    See attachment for primary endpoint data. Secondary endpoint (Influenzaspecific Tcell responses in blood) is not reported upon in this publication as the lung substudy did not start. The T-cell data is not available.
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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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