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    Clinical Trial Results:
    An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ Compared with Engerix-B® in Adults With Chronic Kidney Disease Who Have Previously Received a Hepatitis B Vaccine Series

    Summary
    EudraCT number
    		 2010-022372-31
    Trial protocol
    		 DE  
    Global end of trial date
    09 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Aug 2021
    First version publication date
    25 Aug 2021
    Other versions
    Summary report(s)
    		 study-report-dv2-hbv-19 synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    DV2-HBV-19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01282762
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 US IND Number: BB-IND 12692
    Sponsors
    Sponsor organisation name
    Dynavax Technologies Corporation
    Sponsor organisation address
    2929 Seventh Street, Suite 100 Berkeley, Berkeley, California, United States, 94710
    Public contact
    Referat Klinische Prüfung, Paul-Ehrlich-Institut (PEI), +49 610377 1811, klinpruefung@pei.de
    Scientific contact
    Referat Klinische Prüfung, Paul-Ehrlich-Institut (PEI), +49 610377 1811, klinpruefung@pei.de
    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 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    to evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg ≥ 10 mIU/mL) at baseline; starting 5 months after the secondary vaccine series; and starting 6 months to 1 year after the first booster dose and 6 months to 1 year after each subsequent booster dose; and starting 6 months after baseline for subjects not requiring a secondary series or booster.
    Protection of trial subjects
    All subjects were monitored for safety until study completion. Safety evaluations included assessments of solicited local and systemic post-injection reactions for 7 days following each study injection.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2010
    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 States: 109
    Country: Number of subjects enrolled
    Canada: 17
    Country: Number of subjects enrolled
    Germany: 21
    Worldwide total number of subjects
    147
    EEA total number of subjects
    21
    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)
    72
    From 65 to 84 years
    75
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 18 centres in the US, 2 centres in Canada and 7 centres in Germany.

    Pre-assignment
    Screening details
    		 A total of 147 subjects were enrolled & included in the safety analysis set. Among subjects seroprotected in HBV-17, 9 subjects were removed from the immunogenicity analysis in HBV-19 due to GCP non-compliance. These 9 subjects were seroprotected upon study entry and received no study treatment during HBV-19, therefore there were 138 total subjects

    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
    NA - observational, long-term follow up study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HEPLISAV
    Arm description
    		 HEPLISAV vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    HEPLISAV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg recombinant HBsAg subtype adw 3000 mcg 1018 ISS adjuvant. Single intramuscular injection (0.5 mL) injected in the deltoid muscle at Month 0.Week 0, Month 1/Week 4 and Month 6/Week 24. Lot numbers TDG010 and TDG013

    Arm title
    		 Engerix-B
    Arm description
    		 Engerix-B treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg recombinant HBsAg combined with 500 mcg alum adjuvant. 2 intramuscular injections of 1.0 mL each (for a total dose of 40 mcg BHsAg and 1 mg alum) in the deltoid muscle at Month 0/Week 0, Month 1/Week 4 and Month 6/Week 24. Lot numbers AHBVB910AA and AHBVC111AA (US), AHBVB925AB and AHBVC145AM (Canada) and AHBVB988AB and AHBVC016AC (Germany)

    Number of subjects in period 1
    		HEPLISAV Engerix-B
    Started
    73
    74
    Completed
    53
    55
    Not completed
    20
    19
         Consent withdrawn by subject
    4
    7
         Death
    1
    2
         Other
    1
    3
         Non-GCP Compliance
    7
    2
         Lost to follow-up
    7
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HEPLISAV
    Reporting group description
    		 HEPLISAV vaccine

    Reporting group title
    Engerix-B
    Reporting group description
    		 Engerix-B treatment

    Reporting group values
    		 HEPLISAV Engerix-B Total
    Number of subjects
    		 73 74 147
    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)
    		 34 38 72
        From 65-84 years
    		 39 36 75
        85 years and over
    		 0 0 0
        Not Recorded
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.8 ± 10.44 60.9 ± 11.26 -
    Gender categorical
    Units: Subjects
        Female
    		 22 27 49
        Male
    		 51 47 98
    Subject analysis sets

    Subject analysis set title
    HEPLISAV mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects excluding those with no immunogenicity data who were treated with HEPLISAV

    Subject analysis set title
    HEPLISAV Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects enrolled in the study who were treated with HEPLISAV

    Subject analysis set title
    Engerix-B mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects excluding those with no immunogenicity data who were treated with Engerix-B

    Subject analysis set title
    Engerix-B Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects enrolled in the study who were treated with Engerix-B

    Subject analysis sets values
    		 HEPLISAV mITT HEPLISAV Safety Engerix-B mITT Engerix-B Safety
    Number of subjects
    66
    73
    72
    74
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    34
    38
        From 65-84 years
    39
    36
        85 years and over
    0
    0
        Not Recorded
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    62.8 ± 10.44
    ±
    60.9 ± 11.26
    Gender categorical
    Units: Subjects
        Female
    21
    22
    45
    27
        Male
    45
    51
    27
    47

    End points

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    End points reporting groups
    Reporting group title
    HEPLISAV
    Reporting group description
    		 HEPLISAV vaccine

    Reporting group title
    Engerix-B
    Reporting group description
    		 Engerix-B treatment

    Subject analysis set title
    HEPLISAV mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects excluding those with no immunogenicity data who were treated with HEPLISAV

    Subject analysis set title
    HEPLISAV Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects enrolled in the study who were treated with HEPLISAV

    Subject analysis set title
    Engerix-B mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects excluding those with no immunogenicity data who were treated with Engerix-B

    Subject analysis set title
    Engerix-B Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects enrolled in the study who were treated with Engerix-B

    Primary: Seroprotection rate (SPR)

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    End point title
    		 Seroprotection rate (SPR) [1]
    End point description
    SPR defined as the percentage of subjects with anti-HBsAg greater than or equal to 10 mIU/mL. The comparisons of HEPLISAV and Engerix-B with regards to immunogenicity, and safety endpoints are descriptive. The analyses were performed by seroprotection category and treatment group. The HBV-19 baseline for the immunogenicity analysis was the last (Week 28) HBV-17 laboratory result for subjects who did not have a scheduled baseline HBV-19 result.
    End point type
    Primary
    End point timeframe
    5 months following the secondary vaccine series. 6 months to 1 year following the first booster dose. 6 months to 1 year following each subsequent booster dose. 6 months after baseline if a secondary series or booster was not required.
    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: Desriptive analysis
    End point values
    		 HEPLISAV mITT Engerix-B mITT
    Number of subjects analysed
    58
    61
    Units: Subjects
    42
    42
    No statistical analyses for this end point

    Secondary: Number of injections administered during the study

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    End point title
    		 Number of injections administered during the study
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial period
    End point values
    		 HEPLISAV mITT Engerix-B mITT
    Number of subjects analysed
    66
    72
    Units: Number
    43
    115
    No statistical analyses for this end point

    Secondary: Number of subjects receiving study injections

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    End point title
    		 Number of subjects receiving study injections
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial period
    End point values
    		 HEPLISAV mITT Engerix-B mITT
    Number of subjects analysed
    73
    74
    Units: Number
    24
    32
    No statistical analyses for this end point

    Secondary: SPR in subjects with diabetes mellitus

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    End point title
    		 SPR in subjects with diabetes mellitus
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 5 months after secondary vaccine series, 6 months to 1 year after first booster dose, and 6 months to 1 year after each subsequent booster dose
    End point values
    		 HEPLISAV mITT Engerix-B mITT
    Number of subjects analysed
    31
    29
    Units: Number
    20
    20
    No statistical analyses for this end point

    Secondary: Immunogenicity (anti-HBsAg greater than or equal to 100 mIU/mL)

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    End point title
    		 Immunogenicity (anti-HBsAg greater than or equal to 100 mIU/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 5 months after secondary vaccine series, 6 months to 1 year after the first booster dose, and 6 months to 1 year after each subsequent booster dose.
    End point values
    		 HEPLISAV mITT Engerix-B mITT
    Number of subjects analysed
    47
    50
    Units: Number
    25
    15
    No statistical analyses for this end point

    Secondary: Immunogenicity measured by anti-HBsAg geometric mean concentrations

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    End point title
    		 Immunogenicity measured by anti-HBsAg geometric mean concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 5 months after secondary vaccine series, 6 months to 1 year after the first booster dose, and 6 months to 1 year after each subsequent booster dose
    End point values
    		 HEPLISAV mITT Engerix-B mITT
    Number of subjects analysed
    47
    42
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    176.8 (107.4 to 297.0)
    108.9 (67.1 to 176.7)
    No statistical analyses for this end point

    Other pre-specified: Incidence of local and systemic post-injection reactions for 7 days following each study injection

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    End point title
    		 Incidence of local and systemic post-injection reactions for 7 days following each study injection
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Within 7-days post-injection
    End point values
    		 HEPLISAV Safety Engerix-B Safety
    Number of subjects analysed
    23
    30
    Units: Number
    7
    6
    No statistical analyses for this end point

    Other pre-specified: Incidence of AEs through 4 weeks following a secondary vaccine series or 4 weeks following a booster injection

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    End point title
    		 Incidence of AEs through 4 weeks following a secondary vaccine series or 4 weeks following a booster injection
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Overall trial period
    End point values
    		 HEPLISAV Safety Engerix-B Safety
    Number of subjects analysed
    24
    32
    Units: Number
    4
    6
    No statistical analyses for this end point

    Other pre-specified: Incidence of SAEs (German sites) through 6 months after each study injection

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    End point title
    		 Incidence of SAEs (German sites) through 6 months after each study injection
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Overall trial period
    End point values
    		 HEPLISAV Safety Engerix-B Safety
    Number of subjects analysed
    24
    32
    Units: Number
    1
    1
    No statistical analyses for this end point

    Other pre-specified: Incidence of AESIs

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    End point title
    		 Incidence of AESIs
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Overall trial period
    End point values
    		 HEPLISAV Safety Engerix-B Safety
    Number of subjects analysed
    24
    32
    Units: Number
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All subjects monitored for safety until study completion (48 months). Assessment of solicited local and systemic post injection reactions for 7 days following each injection; AEs and SAEs through 6 months following injection; AESIs until study completion
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    HEPSILAV population receiving at least 1 dose
    Reporting group description
    		 -

    Reporting group title
    Engerix-B population receiving at least 1 dose
    Reporting group description
    		 -

    Serious adverse events
    		 HEPSILAV population receiving at least 1 dose Engerix-B population receiving at least 1 dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 32 (3.13%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmacytoma
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Epidermolysis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-Organ Failure
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 HEPSILAV population receiving at least 1 dose Engerix-B population receiving at least 1 dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 24 (16.67%)
    6 / 32 (18.75%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmacytoma
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Epidermolysis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Multi-organ Failure
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Muscular weakness
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Infected bite
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2011
    Protocol Amendment 1 (Germany)
    03 Dec 2012
    Protocol Amendment 2 (Germany)

    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
    For support, Contact us.
    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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