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    Clinical Trial Results:
    A Phase I clinical trial to assess the safety and immunogenicity of HIV DNA-C CN54ENV immunisations administered via the Intramuscular and Intradermal methods with and without electroporation followed by boosting with recombinant HIV CN54gp140 in healthy male and female volunteers

    Summary
    EudraCT number
    		 2015-001023-23
    Trial protocol
    		 GB  
    Global end of trial date
    22 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2018
    First version publication date
    03 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CUTHIVAC002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02589795
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Tom Cole, Imperial College London, 44 (0)2033136198, t.cole@imperial.ac.uk
    Scientific contact
    Tom Cole, Imperial College London, 44 (0)2033136198, t.cole@imperial.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
    22 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We aim to assess the safety of the HIV vaccines, and also to assess how well they stimulate responses by the body's immune system, when they are given by intradermal and intramuscular injection with or without electroporation.
    Protection of trial subjects
    The wellbeing of trial subjects was monitored closely during the period after each vaccination, through the use of symptom diaries, phone calls, and safety assessments at clinic visits.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    05 Oct 2015
    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: 28
    Worldwide total number of subjects
    28
    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)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All trial subjects were recruited at a single site in the UK: the NIHR Imperial Clinical Research Facility, part of Imperial College Healthcare NHS Trust. The first volunteer was screened on 11 Aug 2016, and the final screening visit was on 15 Feb 2017.

    Pre-assignment
    Screening details
    		 Trial subjects were screened using criteria designed to select healthy volunteers.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Randomised subjects
    Arm description
    		 This arm comprised the initial 24 subjects randomised.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DNA-C CN54ENV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use, Intradermal use
    Dosage and administration details
    Subjects received 3 doses of DNA-C CN54ENV, at 4-weekly intervals, at Weeks 0, 4 and 8 of the trial. Subjects in Group 1 received: intradermal (ID) injections of 0.6 mg, with electroporation (EP), into the skin overlying the deltoid; AND intramuscular (IM) injections of 2 mg, without EP, into the anterolateral thigh/vastus lateralis muscle. Subjects in Group 2 received: ID injections of 0.6 mg, without EP, into the skin overlying the deltoid; AND IM injections of 2 mg, with EP, into the anterolateral thigh/vastus lateralis muscle. Subjects in Group 3 received: ID injections of 0.6 mg, with EP, into the skin overlying the deltoid; AND IM injections of 2 mg, with EP, into the anterolateral thigh/vastus lateralis muscle.

    Investigational medicinal product name
    CN54gp140
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received a single dose of 50 micrograms of CN54gp140, by intradermal injection into the skin overlying the deltoid, at Week 20 of the trial.

    Arm title
    		 Replacement subjects
    Arm description
    		 This arm comprised the 4 subjects recruited to replace subjects in the 'Randomised subjects' arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DNA-C CN54ENV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use, Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of DNA-C CN54ENV, at 4-weekly intervals, at Weeks 0, 4 and 8 of the trial. Subjects in Group 1 received: intradermal (ID) injections of 0.6 mg, with electroporation (EP), into the skin overlying the deltoid; AND intramuscular (IM) injections of 2 mg, without EP, into the anterolateral thigh/vastus lateralis muscle. Subjects in Group 3 received: ID injections of 0.6 mg, with EP, into the skin overlying the deltoid; AND IM injections of 2 mg, with EP, into the anterolateral thigh/vastus lateralis muscle.

    Investigational medicinal product name
    CN54gp140
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received a single dose of 50 micrograms of CN54gp140, by intradermal injection into the skin overlying the deltoid, at Week 20 of the trial.

    Number of subjects in period 1
    		Randomised subjects Replacement subjects
    Started
    24
    4
    Completed
    20
    3
    Not completed
    4
    1
         Consent withdrawn by subject
    2
    -
         Physician decision
    -
    1
         Lost to follow-up
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomised subjects
    Reporting group description
    		 This arm comprised the initial 24 subjects randomised.

    Reporting group title
    Replacement subjects
    Reporting group description
    		 This arm comprised the 4 subjects recruited to replace subjects in the 'Randomised subjects' arm.

    Reporting group values
    		 Randomised subjects Replacement subjects Total
    Number of subjects
    		 24 4 28
    Age categorical
    In order to be eligible for participation, subjects had to be aged 18-50 years on the day of screening.
    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)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Adults 18-50 years
    		 24 4 28
    Age continuous
    In order to be eligible for participation, subjects had to be aged 18-50 years on the day of screening.
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 27 (22 to 43) 31 (27 to 35) -
    Gender categorical
    Units: Subjects
        Female
    		 6 1 7
        Male
    		 18 3 21
    Ethnicity
    Units: Subjects
        White British
    		 17 2 19
        Other white
    		 3 1 4
        Other
    		 4 1 5
    Subject analysis sets

    Subject analysis set title
    Randomised subjects, Group 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the randomised subjects allocated to Group 1

    Subject analysis set title
    Randomised subjects, Group 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the randomised subjects allocated to Group 2

    Subject analysis set title
    Randomised subjects, Group 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the randomised subjects allocated to Group 3

    Subject analysis set title
    Replacement subjects, Group 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the replacement subjects allocated to Group 1

    Subject analysis set title
    Replacement subjects, Group 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the replacement subjects allocated to Group 3

    Subject analysis set title
    All Group 1 subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects allocated to Group 1, including both randomised and replacement subjects

    Subject analysis set title
    All Group 3 subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects allocated to Group 3, including both randomised and replacement subjects

    Subject analysis sets values
    		 Randomised subjects, Group 1 Randomised subjects, Group 2 Randomised subjects, Group 3 Replacement subjects, Group 1 Replacement subjects, Group 3 All Group 1 subjects All Group 3 subjects
    Number of subjects
    8
    8
    8
    1
    3
    9
    11
    Age categorical
    In order to be eligible for participation, subjects had to be aged 18-50 years on the day of screening.
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
    0
        Adults 18-50 years
    8
    8
    8
    1
    3
    9
    11
    Age continuous
    In order to be eligible for participation, subjects had to be aged 18-50 years on the day of screening.
    Units: years
        median (inter-quartile range (Q1-Q3))
    31 (25 to 34)
    27 (23 to 43)
    22 (21 to 47)
    23 ( to )
    35 (27 to 48)
    Gender categorical
    Units: Subjects
        Female
    2
    2
    2
    0
    1
        Male
    6
    6
    6
    1
    2
    Ethnicity
    Units: Subjects
        White British
    6
    5
    6
    1
    1
        Other white
    1
    0
    2
    0
    1
        Other
    1
    3
    0
    0
    1

    End points

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    End points reporting groups
    Reporting group title
    Randomised subjects
    Reporting group description
    		 This arm comprised the initial 24 subjects randomised.

    Reporting group title
    Replacement subjects
    Reporting group description
    		 This arm comprised the 4 subjects recruited to replace subjects in the 'Randomised subjects' arm.

    Subject analysis set title
    Randomised subjects, Group 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the randomised subjects allocated to Group 1

    Subject analysis set title
    Randomised subjects, Group 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the randomised subjects allocated to Group 2

    Subject analysis set title
    Randomised subjects, Group 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the randomised subjects allocated to Group 3

    Subject analysis set title
    Replacement subjects, Group 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the replacement subjects allocated to Group 1

    Subject analysis set title
    Replacement subjects, Group 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This subject analysis set comprises the replacement subjects allocated to Group 3

    Subject analysis set title
    All Group 1 subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects allocated to Group 1, including both randomised and replacement subjects

    Subject analysis set title
    All Group 3 subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects allocated to Group 3, including both randomised and replacement subjects

    Primary: Primary safety endpoint

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    End point title
    		 Primary safety endpoint
    End point description
    Grade 3 or above solicited local, systemic or laboratory adverse event, or any grade of adverse event leading to a clinical decision to discontinue immunizations, or any grade of unsolicited adverse event with onset within 7 days of immunization
    End point type
    Primary
    End point timeframe
    From Week 0 up to Week 22
    End point values
    		 Randomised subjects Replacement subjects Randomised subjects, Group 1 Randomised subjects, Group 2 Randomised subjects, Group 3 Replacement subjects, Group 1 Replacement subjects, Group 3
    Number of subjects analysed
    24
    4
    8
    8
    8
    1
    3
    Units: Number of subjects
    23
    2
    7
    8
    8
    0
    2
    Statistical analysis title
    		 Primary safety endpoint comparisons
    Statistical analysis description
    The proportions of subjects with primary safety outcomes were compared in a pairwise manner between the three randomised groups, using Fisher’s exact tests.
    Comparison groups
    Randomised subjects, Group 1 v Randomised subjects, Group 2 v Randomised subjects, Group 3
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 > 0.05 [2]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - Inequality test
    [2] - All comparisons gave P-values >0.05

    Primary: Primary immunogenicity

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    End point title
    		 Primary immunogenicity
    End point description
    Magnitude of antigen-specific systemic IgG antibody binding responses (ng/mL) to CN54gp140
    End point type
    Primary
    End point timeframe
    Week 22
    End point values
    		 Randomised subjects, Group 2 All Group 1 subjects All Group 3 subjects
    Number of subjects analysed
    8
    9
    11
    Units: nanograms per millilitre
        median (inter-quartile range (Q1-Q3))
    11292 (9608 to 15568)
    13934 (9884 to 38050)
    31418 (6304 to 128259)
    Statistical analysis title
    		 Primary immunogenicity endpoint comparisons
    Statistical analysis description
    Kruskal-Wallis test with Dunn’s correction for multiple comparisons to compare the levels of antigen-specific serum IgG in the three groups at Week 22.
    Comparison groups
    Randomised subjects, Group 2 v All Group 1 subjects v All Group 3 subjects
    Number of subjects included in analysis
    28
    Analysis specification
    Post-hoc
    Analysis type
    		 other [3]
    P-value
    		 > 0.05 [4]
    Method
    		 Kruskal-wallis
    Confidence interval
         level
    		 95%
    Notes
    [3] - Inequality test
    [4] - All comparisons gave p-values >0.05

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 to Week 22
    Adverse event reporting additional description
    Subjects recorded adverse events using a symptom diary for 7 days after each vaccination, and through regular investigator and laboratory assessments
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Randomised subjects
    Reporting group description
    		 This arm comprised the initial 24 subjects randomised.

    Reporting group title
    Replacement subjects
    Reporting group description
    		 This arm comprised the 4 subjects recruited to replace subjects in the 'Randomised subjects' arm.

    Serious adverse events
    		 Randomised subjects Replacement subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
    Additional description: Occurred 5 months after the affected subject's final vaccination
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 4 (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: 5%
    Non-serious adverse events
    		 Randomised subjects Replacement subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    General disorders and administration site conditions
    Musculoskeletal pain
    Additional description: Grade 3 general muscle aches 5 days after the 3rd vaccination; subject in Group 3
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Fatigue
    Additional description: Grade 3 abnormal tiredness 5 and 6 days after the 3rd vaccination; subject in Group 3
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 4 (25.00%)
         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
    04 Sep 2015
    Updates to various documents; submission included Protocol v2.0 and PIS-ICF v2.0
    07 Dec 2015
    Updates to various documents; submission included Protocol v3.0 and PIS-ICF v3.0
    08 May 2017
    Transfer SAE/SUSAR reporting, and monitoring, responsibilities from MRC CTU to ICL; submission comprised Protocol v4.0

    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.
    We have reported the primary endpoints only. For non-serious adverse events we have reported only those graded 3 ('severe') or above, and which occurred at a frequency of >5%.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30027768
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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
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