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    Clinical Trial Results:
    A phase IV, open, multicentric study to evaluate the immune response to a hepatitis B challenge dose in healthy subjects, 72 to 78 months after they received a primary vaccination course of GSK Biologicals’ Engerix-B (thiomersal-free 20 µg or preservative-free 10 µg) vaccine, in the primary study HBV-280

    Summary
    EudraCT number
    		 2007-000261-38
    Trial protocol
    		 BE  
    Global end of trial date
    14 May 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Apr 2023
    First version publication date
    04 Dec 2014
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    108988
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00524576
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 May 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune response to a challenge dose of hepatitis B vaccine administered in subjects who previously received a complete hepatitis B primary vaccination course, 72 to 78 months ago.
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the subjects remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2007
    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
    Australia: 67
    Country: Number of subjects enrolled
    Belgium: 77
    Worldwide total number of subjects
    144
    EEA total number of subjects
    77
    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)
    72
    Adults (18-64 years)
    72
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Engerix 2 doses + challenge dose
    Arm description
    		 Subjects received 2 doses of Engerix-B (Month 0 and 6) in the primary study and a single dose of Engerix-B during the booster study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biological: Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of Engerix-B (Month 0 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Arm title
    		 Engerix 3 doses + challenge dose
    Arm description
    		 Subjects received 3 doses of Engerix-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix-B during the booster study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of Engerix-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Number of subjects in period 1
    		Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Started
    97
    47
    Completed
    97
    47

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Engerix 2 doses + challenge dose
    Reporting group description
    		 Subjects received 2 doses of Engerix-B (Month 0 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Reporting group title
    Engerix 3 doses + challenge dose
    Reporting group description
    		 Subjects received 3 doses of Engerix-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Reporting group values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose Total
    Number of subjects
    		 97 47 144
    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
    Units: years
        arithmetic mean (standard deviation)
    		 19.5 ± 1.22 19.3 ± 1.46 -
    Gender categorical
    Units: Subjects
        Female
    		 50 23 73
        Male
    		 47 24 71

    End points

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    End points reporting groups
    Reporting group title
    Engerix 2 doses + challenge dose
    Reporting group description
    		 Subjects received 2 doses of Engerix-B (Month 0 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Reporting group title
    Engerix 3 doses + challenge dose
    Reporting group description
    		 Subjects received 3 doses of Engerix-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Primary: Number of subjects with immunological response to challenge dose in terms of anti-hepatitis B surface antigen (anti-HBs) antibody concentration

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    End point title
    		 Number of subjects with immunological response to challenge dose in terms of anti-hepatitis B surface antigen (anti-HBs) antibody concentration [1]
    End point description
    Immune response defined as: *For initially seronegative subjects (anti-HBs antibody concentration <3.3 milli-international unit per milliliter [mIU/mL] before vaccination) antibody concentration ≥ 10mIU/mL at post booster. *For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration.
    End point type
    Primary
    End point timeframe
    30 days post-challenge 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Number of subjects analysed
    53
    21
    Units: Subjects
        (anti-HBs) antibody concentration
    53
    21
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-HBs antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with anti-HBs antibody concentrations above the cut-off value
    End point description
    Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    30 days post-challenge dose
    End point values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Number of subjects analysed
    53
    21
    Units: Subjects
        ≥ 3.3 mIU/mL
    53
    21
        ≥ 10 mIU/mL
    53
    21
        ≥ 100 mIU/mL
    50
    20
    No statistical analyses for this end point

    Secondary: Concentration of anti-HBs antibodies

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    End point title
    		 Concentration of anti-HBs antibodies
    End point description
    Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.
    End point type
    Secondary
    End point timeframe
    30 days post-challenge dose
    End point values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Number of subjects analysed
    53
    21
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Concentration of anti-HBs antibodies
    6214.1 (3213.1 to 12018)
    16564.3 (6394.9 to 42905.6)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period (Day 0-3) after the challenge dose
    End point values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Number of subjects analysed
    55
    22
    Units: Subjects
        Pain
    22
    4
        Redness
    11
    1
        Swelling
    9
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms

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    End point title
    		 Number of subjects reporting solicited general symptoms
    End point description
    Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period (Day 0-3) after the challenge dose
    End point values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Number of subjects analysed
    55
    22
    Units: Subjects
        Fatigue
    19
    7
        Fever ≥ 37.5 degree Celsius
    1
    0
        Gastrointestinal disorder
    7
    4
        Headache
    14
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events (AE)

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AE)
    End point description
    An AE was any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period (Day 0-30) after the challenge dose
    End point values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Number of subjects analysed
    55
    22
    Units: Subjects
        Subjects reporting AE
    19
    5
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAE)

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    End point title
    		 Number of subjects reporting serious adverse events (SAE)
    End point description
    An SAE was any untoward medical occurrence that: results in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or evolved into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period (Day 0-30) after the challenge dose
    End point values
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Number of subjects analysed
    55
    22
    Units: Subjects
        Subjects reporting SAE
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse events (SAE) = Day 0 to Day 30. Solicited local and general symptoms =During the 4-day (Days 0-3) post-challenge dose period. Unsolicited AEs = during the 31-day (Day 0-30) follow-up period after the challenge dose.
    Adverse event reporting additional description
    For the other adverse events: Data from the Australian center were not included following data quality issues detected at the investigator site.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Engerix 2 doses + challenge dose
    Reporting group description
    		 Subjects received 2 doses of Engerix-B (Month 0 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Reporting group title
    Engerix 3 doses + challenge dose
    Reporting group description
    		 Subjects received 3 doses of Engerix-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix-B during the booster study.

    Serious adverse events
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Engerix 2 doses + challenge dose Engerix 3 doses + challenge dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 55 (70.91%)
    14 / 22 (63.64%)
    Nervous system disorders
    Headache (AE)
         subjects affected / exposed
    4 / 55 (7.27%)
    2 / 22 (9.09%)
         occurrences all number
    4
    2
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 55 (40.00%)
    4 / 22 (18.18%)
         occurrences all number
    22
    4
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 55 (20.00%)
    1 / 22 (4.55%)
         occurrences all number
    11
    1
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 55 (16.36%)
    0 / 22 (0.00%)
         occurrences all number
    9
    0
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 55 (34.55%)
    7 / 22 (31.82%)
         occurrences all number
    19
    7
    Gastrointestinal disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 55 (12.73%)
    4 / 22 (18.18%)
         occurrences all number
    7
    4
    Headache (Solicited Symptom)
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 55 (25.45%)
    4 / 22 (18.18%)
         occurrences all number
    14
    4

    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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