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    Clinical Trial Results:
    Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines.

    Summary
    EudraCT number
    		 2016-004991-23
    Trial protocol
    		 ES  
    Global end of trial date
    31 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2021
    First version publication date
    08 May 2021
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    IBS-VACANTIB-1701
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03410953
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IBSAL (INSTITUTO DE INVESTIGACION BIOMEDICA)
    Sponsor organisation address
    CAU Salamanca. Hospital Virgen de la Vega, 10ª Planta. Paseo de San Vicente, 58-182, Salamanca, Spain, 37007
    Public contact
    unidad de ensayos clinicos, IBSAL (INSTITUTO DE INVESTIGACION BIOMEDICA), 0034 923210960, ensayosclinicos@ibsal.es
    Scientific contact
    unidad de ensayos clinicos, IBSAL (INSTITUTO DE INVESTIGACION BIOMEDICA), 0034 923210960, ensayosclinicos@ibsal.es
    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
    24 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To benefit and equip SACYL staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine
    Protection of trial subjects
    Adequate information of each patient and efficient monitoring of treatment safety through pharmacovigilance.
    Background therapy
    		 Fendrix®, the hepatitis B vaccine formulated with the new AS04 adjuvant (MPL + aluminum salts) by GlaxoSmithKline.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2017
    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
    Spain: 67
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    67
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B.

    Pre-assignment
    Screening details
    		 Anti-HBs antibody titers of <10 mIU/ml following administration of six 20 µg doses of conventional vaccine (two complete series).

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 FENDRIX
    Arm description
    		 Fendrix®, the hepatitis B vaccine formulated with the new AS04 adjuvant (MPL + aluminum salts) by GlaxoSmithKline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fendrix®
    Investigational medicinal product code
    650862
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose.

    Number of subjects in period 1
    		FENDRIX
    Started
    67
    Completed
    67

    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
    		 67 67
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    subjects had to work in the SNS —including university students undertaking work placements in SNS health centres (subject to and limited by the specific regulations on health and safety in each autonomous region)— and be of working age.
    Units: years
        median (standard deviation)
    		 49.46 ( 11.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 47
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    FENDRIX
    Reporting group description
    		 Fendrix®, the hepatitis B vaccine formulated with the new AS04 adjuvant (MPL + aluminum salts) by GlaxoSmithKline.

    Primary: Seroprotection reached

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    End point title
    		 Seroprotection reached [1]
    End point description
    A cumulative analysis of the response data indicated a gradual increase in subjects reaching seroprotection: 68.66% with the first dose, 86.57% with the second dose, 89.55% with the third dose and 94.03% with the fourth dose.
    End point type
    Primary
    End point timeframe
    first dose second dose third dose fourth dose.
    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: We only need an descriptive analysis. Of the 67 subjects participating in this trial, 63 (94.03%) attained anti-HBs levels of >10 mIU/ml, indicating seroprotection against HBV. A cumulative analysis of the response data indicated a gradual increase in subjects reaching seroprotection: 68.66% with the first dose, 86.57% with the second dose, 89.55% with the third dose and 94.03% with the fourth dose.
    End point values
    		 FENDRIX
    Number of subjects analysed
    67
    Units: 63
    number (not applicable)
        Seroprotected at first dose
    46
        Seroprotected at second dose
    12
        Seroprotected at third dose
    2
        Seroprotected at fourth dose
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    April 13, 2018 and October 31, 2019
    Adverse event reporting additional description
    The 67 participants reported 32 adverse effects (AEs), of which 25 were adverse reaction (AR). None of the adverse effects reported were considered serious and all patients recovered from their corresponding adverse effect, suggesting a low risk of serious adverse effects and an acceptable risk in relation to non-serious adverse effects, which corr
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Vaccinated
    Reporting group description
    		 The 67 participants reported 32 adverse effects (AEs), of which 25 were adverse reaction (AR). None of the adverse effects reported were considered serious and all patients recovered from their corresponding adverse effect, suggesting a low risk of serious adverse effects and an acceptable risk in relation to non-serious adverse effects, which corresponded to those already identified in the Technical Data Sheet.

    Serious adverse events
    		 Vaccinated
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vaccinated
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 67 (31.34%)
    Investigations
    Puncture Zone Pain
         subjects affected / exposed
    14 / 67 (20.90%)
         occurrences all number
    19
    Discomfort
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences all number
    4
    Fatigue
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Diarrhea
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Paresthesia in the puncture area
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Cramp
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Diverticulitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    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.
    One of the greatest difficulties we encountered while conducting this trial was recruitment, as samples from all hospitals were small. This resulted in the need to extend recruitment to additional centres in order to obtain an optimal study sample.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33334613
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