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    Clinical Trial Results:
    Long term antibody response to CMV gB vaccine in patients requiring liver or renal transplant. A Phase II open, single-site study, in participants who received CMV gB vaccine or placebo in previous trial (CTA ref no 20363/0238/001-0010; REC ref no 5476; UCL sponsor no 05/009).

    Summary
    EudraCT number
    2012-002767-95
    Trial protocol
    GB  
    Global end of trial date
    13 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Apr 2019
    First version publication date
    13 Apr 2019
    Other versions
    Summary report(s)
    results for part 2 of this research
    results for part 1 of this research
    extra samples text
    extra samples summary

    Trial information

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    Trial identification
    Sponsor protocol code
    12/0161
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00299260
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower Street, London, United Kingdom, WC1E 6BT
    Public contact
    Paul Griffiths, University College London, 0207 8302997, p.griffiths@ucl.ac.uk
    Scientific contact
    Paul Griffiths, University College London, 0207 8302997, p.griffiths@ucl.ac.uk
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower Street, London, United Kingdom, WC1E 6BT
    Public contact
    Samim Patel, University College London, 44 207 679 9320 , samim.patel@ucl.ac.uk
    Scientific contact
    Samim Patel, University College London, 44 207 679 9320 , samim.patel@ucl.ac.uk
    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
    13 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The Primary objective is in two parts: 1) to see the antibody levels found months to years after patients entered the randomised placebo-controlled trial of a glycoprotein B vaccine against cytomegalovirus and 2) to have the previous samples retested using new and different methods which have been developed in different labs.
    Protection of trial subjects
    This refers to the main study: Negative pregnancy test was required before each vaccine dose Adverse and serious adverse events were tabulated and presented to a Data Safety Committee on six occasions.
    Background therapy
    Immunosuppressive drugs
    Evidence for comparator
    This refers to the main study: Placebo used to assess rate of side effects and immunogenicity
    Actual start date of recruitment
    03 Aug 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Blood samples collected from UK patients who had previously volunteered for a placebo controlled RCT of CMV gB vaccine (report published Lancet 2011) starting 3 December 2013 and ending 9 February 2016.

    Pre-assignment
    Screening details
    Patients who had previously volunteered for a placebo controlled RCT of CMV gB vaccine

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    vaccine or matching placebo were dispensed by a pharmacist according to a randomisation code

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    vaccine seropositive
    Arm description
    CMV glycoprotein B plus MF59 adjuvant
    Arm type
    Experimental

    Investigational medicinal product name
    glycoprotein B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 micrograms plus MF59 adjuvant

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 ml normal saline

    Arm title
    placebo seronegative
    Arm description
    normal saline
    Arm type
    Placebo

    Investigational medicinal product name
    normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.9% saline

    Arm title
    vaccine seronegative
    Arm description
    CMV glycoprotein B plus MF59 adjuvant
    Arm type
    Experimental

    Investigational medicinal product name
    CMV glycoprotein B plus MF59 adjuvant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 micrograms plus MF59 adjuvant

    Arm title
    placebo seropositive
    Arm description
    Normal saline
    Arm type
    Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Normal saline

    Number of subjects in period 1
    vaccine seropositive placebo seronegative vaccine seronegative placebo seropositive
    Started
    5
    10
    8
    8
    Completed
    5
    10
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    31 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    31 31
    Gender categorical
    Units: Subjects
        Female
    12 12
        Male
    19 19
    Subject analysis sets

    Subject analysis set title
    Glycoprotein B antibodies
    Subject analysis set type
    Per protocol
    Subject analysis set description
    measurement of titre of antibodies to glycoprotein B

    Subject analysis sets values
    Glycoprotein B antibodies
    Number of subjects
    31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    31
    Age continuous
    Median 48 (range 20-71)
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    12
        Male
    19

    End points

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    End points reporting groups
    Reporting group title
    vaccine seropositive
    Reporting group description
    CMV glycoprotein B plus MF59 adjuvant

    Reporting group title
    placebo seronegative
    Reporting group description
    normal saline

    Reporting group title
    vaccine seronegative
    Reporting group description
    CMV glycoprotein B plus MF59 adjuvant

    Reporting group title
    placebo seropositive
    Reporting group description
    Normal saline

    Subject analysis set title
    Glycoprotein B antibodies
    Subject analysis set type
    Per protocol
    Subject analysis set description
    measurement of titre of antibodies to glycoprotein B

    Primary: Titre of antibodies against glycoprotein B

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    End point title
    Titre of antibodies against glycoprotein B [1]
    End point description
    End point type
    Primary
    End point timeframe
    Months to years following vaccine
    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: Statistical analysis is not possible because of the small numbers, however, examination of the mean values for each group allows some general conclusions to be made. The seronegatives remain seronegative unless they develop viraemia. The seropositives may have a small boost in antibody level from viraemia. Once these effects of viraemia are taken into account, there is no substantial evidence that the vaccine was responsible for increasing antibody levels.
    End point values
    vaccine seropositive placebo seronegative vaccine seronegative placebo seropositive
    Number of subjects analysed
    5
    10
    8
    8
    Units: Antibody titre
    geometric mean (full range (min-max))
        Viraemia
    2.496 (2.165 to 2.826)
    2.237 (2.223 to 2.467)
    2.287 (2.109 to 2.546)
    3.083 (2.856 to 3.28)
        No viraemia
    2.272 (2.065 to 2.707)
    0.847 (0.311 to 2.059)
    0.852 (0.05 to 2.107)
    2.586 (1.935 to 3.061)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until end of trial 13 June 2016
    Adverse event reporting additional description
    SAEs and SUSARS
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    all patients donating blood

    Serious adverse events
    all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The scope of this sub-study was to look at the long-term antibody response to CMV gB vaccine in patients requiring liver or renal transplant who had participated in the trial: A Phase II Immunogenicity Trial Of Cytomegalovirus Glycoprotein B Vaccine In Allograft Candidate Recipients; CTA ref no 20363/0238/001-0010; REC ref no 5476; UCL sponsor no 05/009. No IMP was administered in the sub-study, one 40ml blood sample taken from the participants was the only intervention.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2014
    A substantial amendment was made on 17 September 2014 to the ethics committee to allow use of blood samples from patients recruited from the first study but who had since died and to analyse the samples overseas. This was approved on 10 October 2014.

    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.
    Note that no clinical trial medication was given to patients during this follow up study. There was no prior hypothesis and only descriptive statistics were used to gain insight into natural history of this infection.
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