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    Clinical Trial Results:
    Ancillary study evaluating ChAd155-hIi-HBV shedding in a subset of chronic hepatitis B patients enrolled in the first-time-in-human, Phase I/II, randomised, multi-centric, single-blind study TH HBV VV-001

    Summary
    EudraCT number
    		 2017-002574-39
    Trial protocol
    		 DE  
    Global end of trial date
    02 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    207811
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    79 New Oxford Street, London, WC1A 1DG, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the shedding of ChAd155-hIi-HBV following intramuscular administration.
    Protection of trial subjects
    The specific measures that were put in place to protect the participants in the TH HBV VV-001 (2017-001452-55) primary study are also applicable for the sub-population included in this ancillary study. Internal Safety Review Committee (iSRC) oversaw the safety and wellbeing of the study participants, with a set of pre-defined holding rules in place. An external (non-GSK) expert with clinical expertise in hepatology worked together with the iSRC to review the safety data and contribute to the decision-making process to hold or continue the study. In the TH HBV VV-001 primary study, vaccines were administered only to eligible participants that had no contraindications to any components of the vaccine. Vaccines were administered by qualified and trained personnel. All participants were observed closely for at least 60 minutes following the administration of the vaccines in the TH HBV VV-001 primary study, with appropriate medical treatment readily available in case of an immediate systemic allergic reaction. All participants were closely followed up for adverse events for 2.5 years.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 2020
    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: 2
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Taiwan: 11
    Country: Number of subjects enrolled
    Thailand: 12
    Worldwide total number of subjects
    53
    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)
    52
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 21 centers in 6 countries: 5 in Germany, 1 in UK, 5 in Taiwan, 1 in France, 2 in Thailand and 7 in Spain.

    Pre-assignment
    Screening details
    		 Out of the 53 participants enrolled in the current ancillary study, 1 participant was eliminated due to protocol deviations, and hence, 52 participants were included in the Exposed set and completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Blinding in this study was directly linked to the blinding in the TH HBV VV-001 (2017-001452-55) primary study. For laboratory testing, samples were not labelled with any reference to the participant number used in the TH HBV VV-001 primary study in order to keep that study blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 B1 Group
    Arm description
    		 Participants received one dose of ChAd155-hIi-HBV high dose formulation vaccine at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.
    Arm type
    		 ChAd155-hIi-HBV shedding evaluation

    Investigational medicinal product name
    ChAd155-hIi-HBV high dose formulation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No study intervention was administered in this ancillary study. Participants received one dose of ChAd155-hIi-HBV high dose formulation vaccine at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study. Throat swab and urine samples were collected from all participants at Day 1 (before study intervention administration in the TH HBV VV-001 primary study), Day 3, Day 8, Day 15 and Day 31 in the current ancillary study.

    Arm title
    		 Control Group
    Arm description
    		 Participants received either one dose of HBc-HBs/AS01B-4 high dose formulation vaccine at Day 1 or one dose of negative control (placebo) at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.
    Arm type
    		 ChAd155-hIi-HBV shedding evaluation

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No study intervention was administered in this ancillary study. Participants received one dose of Placebo at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study. Throat swab and urine samples were collected from all participants at Day 1 (before study intervention administration in the TH HBV VV-001 primary study), Day 3, Day 8, Day 15 and Day 31 in the current ancillary study.

    Investigational medicinal product name
    HBc-HBs/AS01B-4 high dose formulation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No study intervention was administered in this ancillary study. Participants received one dose of HBc-HBs/AS01B-4 high dose formulation vaccine at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study. Throat swab and urine samples were collected from all participants at Day 1 (before study intervention administration in the TH HBV VV-001 primary study), Day 3, Day 8, Day 15 and Day 31 in the current ancillary study.

    Number of subjects in period 1 [1]
    		B1 Group Control Group
    Started
    24
    28
    Completed
    24
    28
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 53 participants enrolled in the current ancillary study, 1 participant was eliminated due to protocol deviations, and hence, 52 participants were included in the Exposed set and completed the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    B1 Group
    Reporting group description
    		 Participants received one dose of ChAd155-hIi-HBV high dose formulation vaccine at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received either one dose of HBc-HBs/AS01B-4 high dose formulation vaccine at Day 1 or one dose of negative control (placebo) at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.

    Reporting group values
    		 B1 Group Control Group Total
    Number of subjects
    		 24 28 52
    Age Categorical
    Units: Participants
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Age at first vaccination in the TH-HBV VV-001 (2017-001452-55) primary study.
    Units: years
        arithmetic mean (standard deviation)
    		 48.5 ( 8.6 ) 49.7 ( 7.1 ) -
    Gender Categorical
    Units: Participants
        Female
    		 5 7 12
        Male
    		 19 21 40
    Race/Ethnicity, Customized
    The "All Other Races" category (i.e., Black Or African American and White where 0<n<11) are combined into one category to maintain participant confidentiality and privacy.
    Units: Subjects
        Asian
    		 12 12 24
        All Other Races
    		 12 16 28

    End points

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    End points reporting groups
    Reporting group title
    B1 Group
    Reporting group description
    		 Participants received one dose of ChAd155-hIi-HBV high dose formulation vaccine at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received either one dose of HBc-HBs/AS01B-4 high dose formulation vaccine at Day 1 or one dose of negative control (placebo) at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.

    Primary: Number of participants with Chimpanzee Adenovirus (ChAd)155 vector Deoxyribonucleic Acid (DNA) in throat swab above the limit of detection (LOD) of the quantitative polymerase chain reaction (qPCR) assay

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    End point title
    		 Number of participants with Chimpanzee Adenovirus (ChAd)155 vector Deoxyribonucleic Acid (DNA) in throat swab above the limit of detection (LOD) of the quantitative polymerase chain reaction (qPCR) assay [1]
    End point description
    The biological samples of throat swab were collected at Days 1, 3, 8, 15 and Day 31 in the current ancillary study. The number of participants with ChAd155 vector DNA detected (i.e. above the LOD of the qPCR assay for ChAd155 vector) in throat swab is tabulated by group. The analysis was performed on the Exposed Set, which included all enrolled participants who received the study interventions at Day 1 in the TH HBV VV-001 (2017-001452-55) primary study and for whom data were available at the specified time points.
    End point type
    Primary
    End point timeframe
    At Days 1, 3, 8, 15, 31
    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
    		 B1 Group Control Group
    Number of subjects analysed
    24
    28
    Units: Participants
        Day 1 (N=23; 28)
    0
    0
        Day 3 (N=21; 25)
    0
    0
        Day 8 (N=23; 27)
    0
    0
        Day 15 (N=24; 27)
    0
    0
        Day 31 (N=22; 27)
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with ChAd155 vector DNA in urine above the LOD of the qPCR assay

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    End point title
    		 Number of participants with ChAd155 vector DNA in urine above the LOD of the qPCR assay [2]
    End point description
    The biological samples of urine were collected at Days 1, 3, 8, 15 and Day 31 in the current ancillary study. The number of participants with ChAd155 vector DNA detected (i.e. above the LOD of the qPCR assay for ChAd155 vector) in urine is tabulated by group. The analysis was performed on the Exposed Set, which included all enrolled participants who received the study interventions at Day 1 in the TH HBV VV-001 (2017-001452-55) primary study and for whom data were available at the specified time points.
    End point type
    Primary
    End point timeframe
    At Days 1, 3, 8, 15, 31
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 B1 Group Control Group
    Number of subjects analysed
    24
    28
    Units: Participants
        Day 1 (N=24; 28)
    0
    0
        Day 3 (N=23; 28)
    0
    0
        Day 8 (N=24; 28)
    0
    0
        Day 15 (N=24; 28)
    0
    0
        Day 31 (N=23; 28)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Not applicable for this study. Safety was being investigated in the TH HBV VV-001 (2017-001452-55) primary study.
    Adverse event reporting additional description
    There were no adverse events data collected during the current ancillary study. Safety results were evaluated in the TH HBV VV-001 (2017-001452-55) primary study and described in the respective results summary.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Participants received either one dose of HBc-HBs/AS01B-4 high dose formulation vaccine at Day 1 or one dose of negative control (placebo) at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.

    Reporting group title
    B1 Group
    Reporting group description
    		 Participants received one dose of ChAd155-hIi-HBV high dose formulation vaccine at Day 1 in step B of the TH-HBV VV-001 (2017-001452-55) primary study and were evaluated for ChAd155-hIi-HBV shedding in the current ancillary study.

    Serious adverse events
    		 Control Group B1 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 24 (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
    		 Control Group B1 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 24 (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: There were no adverse events data collected during this ancillary study. Safety results were evaluated in the primary study TH HBV VV-001 (2017-001452-55) and were described in the respective results summary.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jun 2020
    This protocol amendment 2 outlines measures that may be applicable during special circumstances (e.g., Coronavirus disease 2019 [COVID-19] pandemic). The purpose of the amendment is to protect patient’s welfare and safety, and as far as possible ensure the potential benefit to the patient and promote data integrity. Additionally, since this study is ancillary to the TH HBV VV-001 (2017-001452-55) primary study, applicable changes have been incorporated from the TH HBV VV-001 protocol amendment 5.

    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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