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    Clinical Trial Results:
    Safety and immunogenicity of a Klebsiella pneumoniae tetravalent bioconjugate vaccine (Kleb4V) administered to healthy adults: A FTIH phase I/II randomized and controlled study.

    Summary
    EudraCT number
    		 2020-005090-26
    Trial protocol
    		 DE  
    Global end of trial date
    26 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2023
    First version publication date
    11 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Kleb4V01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LimmaTech Biologics AG
    Sponsor organisation address
    Grabenstrasse 3, Schlieren, Switzerland, 8952
    Public contact
    Carmen Rinaldo, LimmaTech Biologics AG, +41 733 85 85,
    Scientific contact
    Carmen Rinaldo, LimmaTech Biologics AG, +41 733 85 85,
    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
    07 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this Phase I/II study is to obtain first-in-human safety and immunogenicity data following administration of Kleb4V to 55-70 years old adults and identify the preferred formulation of Kleb4V.
    Protection of trial subjects
    The subjects were observed closely for at least 1 hour following the administration of the vaccines, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2021
    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
    Germany: 166
    Worldwide total number of subjects
    166
    EEA total number of subjects
    166
    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)
    130
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 166 participants were enrolled in the study and 166 participants received at least the 1st dose of study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    oberserver-blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (PBS buffer)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    intramuscular injection

    Arm title
    		 Kleb4V Target dose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Kleb4V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    intramuscular injection

    Arm title
    		 Kleb4V Low dose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Kleb4V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    intramuscular injection

    Arm title
    		 Kleb4V Target dose + adjuvant
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Kleb4V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    intramuscular injection

    Investigational medicinal product name
    Kleb4V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    intramuscular injection

    Arm title
    		 Kleb4V Low dose + adjuvant
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Kleb4V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    intramuscular injection

    Number of subjects in period 1
    		Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant
    Started
    34
    36
    30
    36
    30
    Completed
    33
    33
    30
    35
    30
    Not completed
    1
    3
    0
    1
    0
         Adverse event, non-fatal
    -
    1
    -
    -
    -
         subject withdrawal from study due time/Covid-19
    -
    1
    -
    -
    -
         discontinued study after first placebo dose
    1
    -
    -
    -
    -
         subject withdrawal from study due to time problems
    -
    1
    -
    -
    -
         discontinued study after first vaccination
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 166 166
    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)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        18-40 years
    		 16 16
        55-70 years
    		 150 150
    Age continuous
    Units: years
        median (standard deviation)
    		 57.7 ( 10.39 ) -
    Gender categorical
    Units: Subjects
        Female
    		 68 68
        Male
    		 98 98
    Subject analysis sets

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who were randomized and treated were included in the safety set

    Subject analysis set title
    Immunogenicity analysis set - Target Population 55-70 years
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects in the target age population who did not receive the 2nd vaccination and/or had no immunogenicity evaluation available for the visit 1 month post 2nd vaccination (Visit 8) were excluded from the immunogenicity analysis set.

    Subject analysis set title
    Immunogenicity analysis set - Population 18-40 years
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects in the aged 18-40 years who did not receive the 2nd vaccination and/or had no immunogenicity evaluation available for the visit 1 month post 2nd vaccination (Visit 8) were excluded from the immunogenicity analysis set.

    Subject analysis sets values
    		 Safety set Immunogenicity analysis set - Target Population 55-70 years Immunogenicity analysis set - Population 18-40 years
    Number of subjects
    166
    146
    14
    Age categorical
    Units: Subjects
        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
        18-40 years
    16
    0
    14
        55-70 years
    150
    146
    0
    Age continuous
    Units: years
        median (standard deviation)
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    68
    60
    8
        Male
    98
    86
    6

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Target dose
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Low dose
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Target dose + adjuvant
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Low dose + adjuvant
    Reporting group description
    		 -

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who were randomized and treated were included in the safety set

    Subject analysis set title
    Immunogenicity analysis set - Target Population 55-70 years
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects in the target age population who did not receive the 2nd vaccination and/or had no immunogenicity evaluation available for the visit 1 month post 2nd vaccination (Visit 8) were excluded from the immunogenicity analysis set.

    Subject analysis set title
    Immunogenicity analysis set - Population 18-40 years
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects in the aged 18-40 years who did not receive the 2nd vaccination and/or had no immunogenicity evaluation available for the visit 1 month post 2nd vaccination (Visit 8) were excluded from the immunogenicity analysis set.

    Primary: Number of Subjects with Solicited AEs by Severity - After First Injection

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    End point title
    		 Number of Subjects with Solicited AEs by Severity - After First Injection [1]
    End point description
    End point type
    Primary
    End point timeframe
    7 days after first vaccination
    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: Safety data were evaluated descriptively
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant Safety set
    Number of subjects analysed
    34
    36
    30
    36
    30
    166
    Units: number of subjects
        Mild
    10
    17
    6
    31
    23
    87
        Moderate
    2
    7
    1
    13
    6
    29
        Severe
    0
    1
    0
    3
    1
    5
    No statistical analyses for this end point

    Primary: Number of Subjects with Solicited AEs by Severity - After Second Injection

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    End point title
    		 Number of Subjects with Solicited AEs by Severity - After Second Injection [2]
    End point description
    End point type
    Primary
    End point timeframe
    7 days after second vaccination
    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: Safety data were evaluated descriptively
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant Safety set
    Number of subjects analysed
    34
    36
    30
    36
    30
    166
    Units: number of subjects
        Mild
    5
    21
    15
    26
    22
    89
        Moderate
    3
    9
    5
    15
    7
    39
        Severe
    0
    2
    0
    4
    4
    10
    No statistical analyses for this end point

    Primary: Number of Subjects with Solicited AEs by Relationship

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    End point title
    		 Number of Subjects with Solicited AEs by Relationship [3]
    End point description
    End point type
    Primary
    End point timeframe
    from first vaccination until 7 days post second vaccination
    Notes
    [3] - 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: Safety data were evaluated descriptively
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant Safety set
    Number of subjects analysed
    34
    36
    30
    36
    30
    166
    Units: number of subjects
        related
    13
    30
    18
    35
    27
    123
        not related
    1
    1
    0
    1
    0
    3
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited AEs by Severity

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    End point title
    		 Number of Subjects with Unsolicited AEs by Severity [4]
    End point description
    End point type
    Primary
    End point timeframe
    28 days after first vaccination
    Notes
    [4] - 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: Safety data were evaluated descriptively
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant Safety set
    Number of subjects analysed
    34
    36
    30
    36
    30
    166
    Units: number of subjects
        Mild
    11
    19
    8
    19
    6
    62
        Moderate
    10
    12
    4
    9
    7
    42
        Severe
    4
    1
    1
    2
    0
    8
        Potentially Life Threatening
    0
    0
    0
    1
    0
    1
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited AEs by Relationship

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    End point title
    		 Number of Subjects with Unsolicited AEs by Relationship [5]
    End point description
    End point type
    Primary
    End point timeframe
    from first vaccination until 28 post second vaccination
    Notes
    [5] - 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: Safety data were evaluated descriptively
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant Safety set
    Number of subjects analysed
    34
    36
    30
    36
    30
    166
    Units: number of subjects
        related
    7
    13
    5
    16
    5
    46
        not related
    14
    15
    8
    12
    7
    56
    No statistical analyses for this end point

    Primary: Number of Subjects with a SAEs

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    End point title
    		 Number of Subjects with a SAEs [6]
    End point description
    End point type
    Primary
    End point timeframe
    from first vaccination until study end
    Notes
    [6] - 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: Safety data were evaluated descriptively
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant Safety set
    Number of subjects analysed
    34
    36
    30
    36
    30
    166
    Units: number of subjects
        related to study treatment
    0
    0
    0
    0
    0
    0
        not related to study treatment
    3
    1
    0
    1
    0
    5
    No statistical analyses for this end point

    Primary: Number of Subjects with AESIs

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    End point title
    		 Number of Subjects with AESIs [7]
    End point description
    End point type
    Primary
    End point timeframe
    from first vaccination until study end
    Notes
    [7] - 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: Safety data were evaluated descriptively
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant Safety set
    Number of subjects analysed
    34
    36
    30
    36
    30
    166
    Units: number of subjects
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Geometric mean titre of Serum IgG for all serotypes 28 days after the second injection - target population 55-70 years

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    End point title
    		 Geometric mean titre of Serum IgG for all serotypes 28 days after the second injection - target population 55-70 years
    End point description
    End point type
    Primary
    End point timeframe
    28 days post second vaccination
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant
    Number of subjects analysed
    29
    29
    29
    29
    30
    Units: titer
    geometric mean (confidence interval 95%)
        O1v1
    92.3 (54.0 to 157.9)
    4115.5 (2405.0 to 7042.6)
    2709.3 (1582.2 to 4639.4)
    4107.5 (2398.8 to 7033.4)
    2520.4 (1472.3 to 4314.7)
        O2a
    78.7 (44.7 to 138.2)
    1161.6 (660.4 to 2043.2)
    853.3 (483.2 to 1507.1)
    1984.6 (1129.1 to 3488.4)
    1398.1 (794.9 to 2458.8)
        O2afg
    40.1 (22.5 to 71.6)
    757.1 (424.7 to 1349.6)
    487.0 (273.2 to 868.0)
    1692.6 (948.5 to 3020.5)
    690.4 (387.4 to 1230.7)
        O3b
    35.9 (23.0 to 56.2)
    121.6 (78.1 to 189.5)
    126.9 (81.5 to 197.7)
    238.6 (153.1 to 371.9)
    168.8 (108.4 to 263.0)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    For treatment group comparison, the primary endpoint was evaluated in terms of ratio of GMTs, referred to as geometric mean ratio (GMR) between treatment groups (i.e., GMR of the post-vaccination immunogenicity values) evaluated via analysis of covariance (ANCOVA) including treatment as fixed factor and baseline titre as covariate. The ANCOVA was conducted for the cohort of 55-70y by serotype on the log-transformed values and considered the immunogenicity analysis set for evaluation.
    Comparison groups
    Placebo v Kleb4V Target dose v Kleb4V Low dose v Kleb4V Target dose + adjuvant v Kleb4V Low dose + adjuvant
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Geometric mean ratios
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [8] - The four statistical comparisons at V8 of each active treatment group versus the placebo group were carried in a formal way, using the Dunnett’s procedure for dealing with multiplicity (study-wise alpha=0.05). Treatment ratios, adjusted p-values and two-sided confidence intervals with adjusted coverage were computed for these primary comparisons after back-transformation of the results to the original scale.

    Primary: Geometric mean titre of Serum IgG for all serotypes at baseline - population 18-40 years

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    End point title
    		 Geometric mean titre of Serum IgG for all serotypes at baseline - population 18-40 years [9] [10]
    End point description
    End point type
    Primary
    End point timeframe
    28 days after the second injection
    Notes
    [9] - 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: Statistical evaluation performed in the target population 55-70 years
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical evaluation performed in the target population 55-70 years
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Target dose + adjuvant
    Number of subjects analysed
    3
    5
    6
    Units: titer
    geometric mean (confidence interval 95%)
        O1v1
    116.31 (1.07 to 12631.75)
    121.49 (11.62 to 1270.23)
    110.14 (67.43 to 179.91)
        O2a
    20.83 (0.21 to 2101.48)
    97.85 (23.45 to 408.27)
    61.12 (16.37 to 228.24)
        O2afg
    43.44 (4.17 to 452.70)
    98.11 (70.47 to 136.61)
    77.73 (24.49 to 246.73)
        O3b
    43.68 (1.90 to 1002.81)
    60.04 (10.58 to 340.82)
    125.06 (51.81 to 301.83)
    No statistical analyses for this end point

    Primary: Geometric mean titre of Serum IgG for all serotypes at baseline - target population 55-70 years

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    End point title
    		 Geometric mean titre of Serum IgG for all serotypes at baseline - target population 55-70 years
    End point description
    End point type
    Primary
    End point timeframe
    at baseline
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant
    Number of subjects analysed
    29
    29
    29
    29
    30
    Units: titer
    geometric mean (confidence interval 95%)
        O1v1
    53.51 (27.65 to 103.56)
    47.96 (22.42 to 102.59)
    43.89 (26.30 to 73.25)
    71.42 (37.17 to 137.24)
    71.29 (38.04 to 133.58)
        O2a
    63.04 (35.40 to 112.28)
    72.85 (39.67 to 133.76)
    39.10 (22.61 to 67.63)
    65.21 (37.12 to 114.57)
    76.50 (41.88 to 139.77)
        O2afg
    23.10 (13.72 to 38.89)
    27.46 (13.62 to 55.36)
    32.06 (16.75 to 61.37)
    38.23 (19.68 to 74.30)
    34.74 (20.72 to 58.25)
        O3b
    25.94 (13.69 to 49.14)
    48.09 (28.35 to 81.59)
    35.22 (19.28 to 64.32)
    50.28 (28.09 to 90.00)
    52.64 (30.38 to 91.19)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    For treatment group comparison, the primary endpoint was evaluated in terms of ratio of GMTs, referred to as geometric mean ratio (GMR) between treatment groups (i.e., GMR of the post-vaccination immunogenicity values) evaluated via analysis of covariance (ANCOVA) including treatment as fixed factor and baseline titre as covariate. The ANCOVA was conducted for the cohort of 55-70y by serotype on the log-transformed values and considered the Immunogenicity Analysis Set for evaluation
    Comparison groups
    Placebo v Kleb4V Target dose v Kleb4V Low dose v Kleb4V Target dose + adjuvant v Kleb4V Low dose + adjuvant
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Geometric mean ratios
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Geometric mean titre of Serum IgG for all serotypes 28 days after the second injection - population 18-40 years

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    End point title
    		 Geometric mean titre of Serum IgG for all serotypes 28 days after the second injection - population 18-40 years [11] [12]
    End point description
    End point type
    Primary
    End point timeframe
    28 days after the second injection
    Notes
    [11] - 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: Statistical evaluation performed in the target population 55-70 years
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical evaluation performed in the target population 55-70 years
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Target dose + adjuvant
    Number of subjects analysed
    3
    5
    6
    Units: titer
    geometric mean (confidence interval 95%)
        O1v1
    34.65 (0.12 to 9982.14)
    9186.73 (1726.37 to 48886.50)
    3553.19 (2379.79 to 5305.15)
        O2a
    10.00 (0.45 to 223.70)
    1040.84 (14.08 to 76953.88)
    1271.22 (301.04 to 5368.15)
        O2afg
    4.85 (0.28 to 83.52)
    2396.04 (749.01 to 7664.86)
    753.84 (163.39 to 3477.98)
        O3b
    11.35 (4.59 to 28.06)
    25.93 (8.08 to 83.26)
    242.10 (137.91 to 425.01)
    No statistical analyses for this end point

    Secondary: Geometric mean titre of Serum IgG for all serotypes 28 days after the first injection - target population 55-70 years

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    End point title
    		 Geometric mean titre of Serum IgG for all serotypes 28 days after the first injection - target population 55-70 years
    End point description
    End point type
    Secondary
    End point timeframe
    V5, 28 days after first injection
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant
    Number of subjects analysed
    29
    29
    29
    29
    30
    Units: titer
    geometric mean (confidence interval 95%)
        O1v1
    49.22 (26.15 to 92.64)
    3209.11 (1729.01 to 5956.22)
    1930.72 (875.16 to 4259.44)
    5791.70 (2770.82 to 12106.06)
    3514.79 (1757.17 to 7030.47)
        O2a
    58.15 (33.79 to 100.07)
    1350.09 (598.66 to 3044.71)
    528.42 (219.02 to 1274.89)
    2674.16 (1257.11 to 5688.54)
    1682.20 (775.48 to 3649.08)
        O2afg
    20.14 (11.84 to 34.25)
    471.19 (188.72 to 1176.45)
    431.10 (143.59 to 1294.29)
    1940.48 (703.69 to 5351.01)
    399.22 (186.50 to 854.53)
        O3b
    24.97 (13.14 to 47.44)
    104.91 (57.04 to 192.93)
    84.95 (45.26 to 159.43)
    239.19 (131.24 to 435.94)
    124.66 (68.01 to 228.51)
    No statistical analyses for this end point

    Secondary: Antibody Functionality for O1v1 - target population 55-70 years

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    End point title
    		 Antibody Functionality for O1v1 - target population 55-70 years
    End point description
    End point type
    Secondary
    End point timeframe
    baseline (V2), 28 days after first vaccination (V5), 28 days after second vaccination (V8)
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant
    Number of subjects analysed
    29
    29
    29
    29
    30
    Units: titer
    geometric mean (confidence interval 95%)
        Baseline
    2529.6 (1254.1 to 5102.2)
    3394.7 (1445.5 to 7972.5)
    1338.4 (489.9 to 3656.4)
    4382.5 (2304.7 to 8333.5)
    3310.1 (2172.7 to 5042.9)
        V5
    2552.0 (1185.1 to 5495.4)
    30124.9 (20582.3 to 44091.8)
    19135.3 (12368.4 to 29604.3)
    31342.4 (20545.8 to 47812.6)
    23544.4 (16030.9 to 34579.5)
        V8
    2858.6 (1467.2 to 5569.7)
    30636.7 (23077.3 to 40672.4)
    17459.6 (11910.5 to 25594.0)
    28983.9 (21535.1 to 39009.3)
    18892.7 (9496.9 to 37584.2)
    No statistical analyses for this end point

    Secondary: Antibody Functionality for O2afg - target population 55-70 years

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    End point title
    		 Antibody Functionality for O2afg - target population 55-70 years
    End point description
    End point type
    Secondary
    End point timeframe
    baseline (V2), 28 days after first vaccination (V5), 28 days after second vaccination (V8)
    End point values
    		 Placebo Kleb4V Target dose Kleb4V Low dose Kleb4V Target dose + adjuvant Kleb4V Low dose + adjuvant
    Number of subjects analysed
    29
    29
    29
    29
    30
    Units: titer
    geometric mean (confidence interval 95%)
        V2
    857.4 (519.9 to 1413.9)
    1341.0 (888.2 to 2024.6)
    1256.3 (764.4 to 2064.7)
    1826.5 (1133.4 to 2943.5)
    1080.4 (559.2 to 2087.2)
        V5
    859.0 (504.2 to 1463.4)
    4834.5 (3208.1 to 7285.4)
    3872.4 (2511.4 to 5970.9)
    10080.2 (6712.1 to 15138.4)
    4038.3 (2595.3 to 6283.5)
        V8
    1157.9 (704.5 to 1903.1)
    9453.0 (6557.6 to 13626.7)
    6896.2 (4474.1 to 10629.6)
    16258.4 (11700.1 to 22592.5)
    12751.6 (8551.7 to 19014.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events were collected for 7 days after each injection. Unsolicited adverse events were collected for 28 days after each injection. Medically relevant AEs, AESIs and SAEs were collected for the entire study duration.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Low dose
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Low dose + adjuvant
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Target dose
    Reporting group description
    		 -

    Reporting group title
    Kleb4V Target dose + adjuvant
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Kleb4V Low dose Kleb4V Low dose + adjuvant Kleb4V Target dose Kleb4V Target dose + adjuvant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal carcinoma
    Additional description: Oesophageal carcinoma
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Tendon rupture
    Additional description: Tendon rupture
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
    Additional description: Acute coronary syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Kleb4V Low dose Kleb4V Low dose + adjuvant Kleb4V Target dose Kleb4V Target dose + adjuvant
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 34 (64.71%)
    18 / 30 (60.00%)
    27 / 30 (90.00%)
    33 / 36 (91.67%)
    36 / 36 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Surgical and medical procedures
    Lesion excision
    Additional description: Lesion excision
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Axillary pain
    Additional description: Axillary pain
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Chills
    Additional description: Chills
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    1
    2
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    10 / 34 (29.41%)
    7 / 30 (23.33%)
    15 / 30 (50.00%)
    15 / 36 (41.67%)
    10 / 36 (27.78%)
         occurrences all number
    17
    15
    22
    28
    27
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    2
    Injection site erythema
    Additional description: Injection site erythema
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 30 (13.33%)
    7 / 30 (23.33%)
    9 / 36 (25.00%)
    12 / 36 (33.33%)
         occurrences all number
    1
    5
    16
    15
    32
    Injection site haematoma
    Additional description: Injection site haematoma
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    1
    1
    Injection site induration
    Additional description: Injection site induration
         subjects affected / exposed
    0 / 34 (0.00%)
    3 / 30 (10.00%)
    5 / 30 (16.67%)
    7 / 36 (19.44%)
    12 / 36 (33.33%)
         occurrences all number
    0
    4
    9
    13
    32
    Injection site macule
    Additional description: Injection site macule
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Injection site muscle weakness
    Additional description: Injection site muscle weakness
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site pain
    Additional description: Injection site pain
         subjects affected / exposed
    4 / 34 (11.76%)
    11 / 30 (36.67%)
    26 / 30 (86.67%)
    26 / 36 (72.22%)
    35 / 36 (97.22%)
         occurrences all number
    4
    17
    48
    47
    83
    Injection site pruritus
    Additional description: Injection site pruritus
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 36 (2.78%)
    5 / 36 (13.89%)
         occurrences all number
    0
    3
    3
    1
    8
    Injection site warmth
    Additional description: Injection site warmth
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    0
    0
    5
    Injection site swelling
    Additional description: Injection site swelling
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 30 (13.33%)
    6 / 30 (20.00%)
    4 / 36 (11.11%)
    15 / 36 (41.67%)
         occurrences all number
    1
    5
    11
    7
    32
    Injection site reaction
    Additional description: Injection site reaction
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain
    Additional description: Pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    2
    1
    1
    Thirst
    Additional description: Thirst
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Immune system disorders
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
    Additional description: Bronchospasm
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Cough
    Additional description: Cough
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    1
    1
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Investigations
    Blood potassium decreased
    Additional description: Blood potassium decreased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    C-reactive protein increased
    Additional description: C-reactive protein increased
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    1
    1
    Haemoglobin decreased
    Additional description: Haemoglobin decreased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Face injury
    Additional description: Face injury
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Limb injury
    Additional description: Limb injury
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Superficial injury of eye
    Additional description: Superficial injury of eye
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cardiac disorders
    Cardiovascular disorder
    Additional description: Cardiovascular disorder
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Disturbance in attention
    Additional description: Disturbance in attention
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Headache
    Additional description: Headache
         subjects affected / exposed
    5 / 34 (14.71%)
    4 / 30 (13.33%)
    10 / 30 (33.33%)
    11 / 36 (30.56%)
    13 / 36 (36.11%)
         occurrences all number
    8
    5
    15
    22
    30
    Hyperaesthesia
    Additional description: Hyperaesthesia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    Presyncope
    Additional description: Presyncope
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Somnolence
    Additional description: Somnolence
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
    Additional description: Leukocytosis
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    0
    1
    1
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    0
    2
    4
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    2
    0
    0
    0
    3
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    3
    1
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Irritable bowel syndrome
    Additional description: Irritable bowel syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lip oedema
    Additional description: Lip oedema
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 36 (5.56%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    1
    3
    2
    Tongue dry
    Additional description: Tongue dry
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Angiodermatitis
    Additional description: Angiodermatitis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blister
    Additional description: Blister
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dermal cyst
    Additional description: Dermal cyst
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Rash maculo-papular
    Additional description: Rash maculo-papular
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    3 / 36 (8.33%)
         occurrences all number
    1
    0
    0
    2
    4
    Muscle tightness
    Additional description: Muscle tightness
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    4 / 34 (11.76%)
    2 / 30 (6.67%)
    11 / 30 (36.67%)
    9 / 36 (25.00%)
    14 / 36 (38.89%)
         occurrences all number
    4
    2
    16
    16
    24
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    3
    Periostosis
    Additional description: Periostosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Asymptomatic COVID-19
    Additional description: Asymptomatic COVID-19
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Campylobacter gastroenteritis
    Additional description: Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    3 / 34 (8.82%)
    4 / 30 (13.33%)
    1 / 30 (3.33%)
    5 / 36 (13.89%)
    4 / 36 (11.11%)
         occurrences all number
    3
    4
    1
    5
    4
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    7 / 36 (19.44%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    2
    8
    1
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Periodontitis
    Additional description: Periodontitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pulpitis dental
    Additional description: Pulpitis dental
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Rhinitis
    Additional description: Rhinitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2021
    Definition of the Immunogenicity Analysis set. Update in the protocol with regards to opening of step 2: The Data Safety Review Committee (DSRC) opened enrolment of step 2 after DSRC meeting 3 instead of DSRC meeting 2 to assess cumulative safety data collected for 7 days from the 2nd injection of step 1-subjects before opening step 2.

    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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