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    Clinical Trial Results:
    Phase 2 multicenter study investigating the tolerability and efficacy of UV1 vaccine in patients with recurrent or metastatic PD-L1 positive (CPS≥1) head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab

    Summary
    EudraCT number
    		 2020-005910-17
    Trial protocol
    		 DE  
    Global end of trial date
    26 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2025
    First version publication date
    27 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KKSH176
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05075122
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Martin-Luther-University Halle-Wittenberg
    Sponsor organisation address
    Magdeburger Str. 8, Halle, Germany, 06112
    Public contact
    Coordinating Investigator, Universitätsklinikum Halle, mascha.binder@usb.de
    Scientific contact
    Coordinating Investigator, Universitätsklinikum Halle, mascha.binder@usb.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
    26 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the clinical performance of the UV1 vaccine as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1%) head and neck squamous cell carcinoma in terms of progression free survival according to iRECIST (PFSR@6 months).
    Protection of trial subjects
    Treatment of injection site reactions/ allergic reactions was done at investigators discretion. Subject protection was ensured by following high medical and ethical standards consistent with Good Clinical Practice and applicable regulations. The responsible investigator will ensure that this study is conducted in agreement with the Declaration of Helsinki (in its current version) and the laws and regulations. The protocol has been written, and the study was conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    37
    From 65 to 84 years
    33
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between August 04, 2021 and July 18, 2023, 75 patients were enrolled at 10 trial sites in Germany. The last patient finished the study treatment in October 17, 2023 and the follow-up period in July 17, 2024.

    Pre-assignment
    Screening details
    		 All patients with recurrent or metastatic PD-L1 positive (CPS≥1) head and neck squamous cell carcinoma presenting at the participating trial sites planned for first-line treatment with pembrolizumab were screened for this trial. All patients who met the inclusion/ exclusion criteria were offered participation in this trial.

    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
    		 A (Calibration Arm)
    Arm description
    		 Patients recived pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.
    Arm type
    		 Calibration arm

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200mg flat dose iv every 3 weeks

    Arm title
    		 B (Vaccination arm)
    Arm description
    		 Patients received three UV1 vaccinations the week before initiation of pembrolizumab followed by 5 additional UV1 vaccinations every 3 weeks. Patients received pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200mg flat dose iv every 3 weeks

    Investigational medicinal product name
    UV1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    UV1 vaccination (300 μg UV1 plus 75 μg GM-CSF as adjuvant per vaccination). UV1 vaccination will be applied in a dense schedule with three vaccinations during one week before initiation of pembrolizumab, followed by 5 additional vaccinations every 3 weeks given at the same day as pembrolizumab.

    Number of subjects in period 1
    		A (Calibration Arm) B (Vaccination arm)
    Started
    25
    50
    Completed
    25
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    A (Calibration Arm)
    Reporting group description
    		 Patients recived pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.

    Reporting group title
    B (Vaccination arm)
    Reporting group description
    		 Patients received three UV1 vaccinations the week before initiation of pembrolizumab followed by 5 additional UV1 vaccinations every 3 weeks. Patients received pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.

    Reporting group values
    		 A (Calibration Arm) B (Vaccination arm) Total
    Number of subjects
    		 25 50 75
    Age categorical
    The trial population included 60 men aund 15 women.
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.5 ( 11.3 ) 67.5 ( 10.5 ) -
    Gender categorical
    The trial population (75) included 60 men and 15 women.
    Units: Subjects
        female
    		 7 8 15
        male
    		 18 42 60
    ECOG Performance Status
    Units: Subjects
        ECOG 0
    		 8 17 25
        ECOG 1
    		 9 24 33
        ECOG 2
    		 7 6 13
        ECOG 3
    		 0 1 1
        Missing value
    		 1 2 3
    Disease status at Recruitment
    Units: Subjects
        Relapse
    		 21 34 55
        Initial diagnosis
    		 4 16 20
    Tumor stage at the time of recruitment
    Units: Subjects
        T1
    		 3 5 8
        T2
    		 3 7 10
        T3
    		 3 11 14
        T4a
    		 7 17 24
        T4b
    		 1 5 6
        TX
    		 8 5 13
    N stage at recruitment
    Units: Subjects
        N0
    		 5 11 16
        T1
    		 2 5 7
        T2
    		 10 18 28
        T3
    		 6 13 19
        TX
    		 2 3 5
    M stage at recruitment
    Units: Subjects
        M0
    		 9 26 35
        M1
    		 15 20 35
        MX
    		 1 4 5
    Disease stage at recruitment
    Units: Subjects
        Stage I
    		 0 1 1
        Stage II
    		 0 5 5
        Stage III
    		 1 4 5
        Stage IVa
    		 6 12 18
        Stage IVb
    		 6 9 15
        Stage IVc
    		 12 16 28
        N.A.
    		 0 3 3
    Time since diagnosis of current disease status
    Units: Months
        arithmetic mean (standard deviation)
    		 3.1 ( 3.7 ) 4.8 ( 7.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    A (Calibration Arm)
    Reporting group description
    		 Patients recived pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.

    Reporting group title
    B (Vaccination arm)
    Reporting group description
    		 Patients received three UV1 vaccinations the week before initiation of pembrolizumab followed by 5 additional UV1 vaccinations every 3 weeks. Patients received pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The database included information on 75 randomized, evaluable patients, 25 in arm A (control, or reference arm) and 50 in arm B (experimental arm with vaccination), forming the ITT full analysis set.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The database included information on 75 randomized, evaluable patients, 25 in arm A (control, or reference arm) and 50 in arm B (experimental arm with vaccination), forming the ITT full analysis set. One patient without receiving a first protocol-defined pembrolizumab cycle was excluded from the per-protocol (PP) population.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis is based on the total population of 75 patients.

    Primary: Crude proportion of Progression free survival (PFS)

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    End point title
    		 Crude proportion of Progression free survival (PFS)
    End point description
    PFS is defined as the time from randomization to the date of first observed disease progression (investigator assessment according to iRECIST) or death from any cause. Clinical deterioration in the absence of unequivocal evidence of progression (per iRECIST) is not considered progression for purposes of determining PFS. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment. Subjects who did not have any on study tumor assessments and did not die will be censored on the date they were registered. Subjects who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of the subsequent anti-cancer therapy.
    End point type
    Primary
    End point timeframe
    patients surviving without progression at 6 months after randomisation
    End point values
    		 A (Calibration Arm) B (Vaccination arm)
    Number of subjects analysed
    25
    50
    Units: %
    number (confidence interval 90%)
        Crude rate of PFS
    40 (24 to 58)
    30 (19 to 42)
    Attachments
    		 Progression-free survival from randomisation (ITT)
    Statistical analysis title
    		 Number of patients surviving free from progression
    Statistical analysis description
    With respect to the formal study hypothesis, the two-sided 80% CI (corresponding to the 90% one-sided CI as relevant for superiority) of the rate in the experimental arm does not exclude the 25% boundary, which was pre-defined as futility threshold. Moreover, the 40% finding in the group treated with pembrolizumab alone is higher than expected, possibly suggesting a somewhat favourable patient selection in the FOCUS study. Thus, a positive signal for the experimental treatment cannot be derived.
    Comparison groups
    A (Calibration Arm) v B (Vaccination arm)
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.44
    Method
    		 Fisher exact
    Confidence interval

    Primary: Crude PFS rate after 6 months, per-protocol

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    End point title
    		 Crude PFS rate after 6 months, per-protocol
    End point description
    Patient # 01-061 excluded from the ITT analysis due to the lack of any documentation beyond randomisation, is included in a “worst-case” analysis, the crude proportion of patients known to be surviving progression-free at 6 months reduces to 15/51 (29%).
    End point type
    Primary
    End point timeframe
    6 months from randomisation
    End point values
    		 A (Calibration Arm) B (Vaccination arm)
    Number of subjects analysed
    25
    49
    Units: %
        number (confidence interval 95%)
    40 (21 to 61)
    31 (18 to 45)
    Statistical analysis title
    		 Patients surviving free from progression (PP)
    Comparison groups
    A (Calibration Arm) v B (Vaccination arm)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Response at end of protocol therapy (ITT)

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    End point title
    		 Response at end of protocol therapy (ITT)
    End point description
    Tumor response according to iRECIST. Only 67 out of 75 patients had a valid restaging result at this time point. The corresponding overall response rate (CR + PR = ORR), is 45% in the control arm (95% CI: 24 … 68%) and 22% in the vaccine arm (95% CI: 11 … 37%) (p = 0.086, Fisher’s exact test; descriptive only, due to insufficient power for formal hypothesis test). If the patients without a valid restaging information after protocol therapy are counted as failures (intention-to-treat approach) the corresponding proportions are 10/25 (40%) and 10/50 (20%).
    End point type
    Secondary
    End point timeframe
    Investigated at end of protocol therapy.
    End point values
    		 A (Calibration Arm) B (Vaccination arm) ITT
    Number of subjects analysed
    22
    45
    67
    Units: %
    number (not applicable)
        CR
    14
    4
    7
        PR
    32
    18
    22
        SD
    5
    13
    10
        PD unconfirmed
    18
    27
    24
        PD confirmed
    32
    38
    36
    No statistical analyses for this end point

    Secondary: Overall best response during treatment and follow-up (ITT)

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    End point title
    		 Overall best response during treatment and follow-up (ITT)
    End point description
    The overall best response category achieved during the protocol and the complete follow-up period based on 68 patients with at least one valid iRECIST assessment. Of note, these data may be confounded by non-randomly distributed further antineoplastic treatments during follow-up. The corresponding ORR is 59% in the control arm (95% CI: 36 … 79%) and 33% in the vaccine arm (95% CI: 20 … 48%) (p = 0.064, Fisher’s exact test; descriptive only, due to insufficient power for formal hypothesis test), indicating that some additional objective responses were detected after second-line therapy. If the patients without a valid restaging information at all are counted as failures, the corresponding proportions are 13/25 (52%) and 15/50 (30%).
    End point type
    Secondary
    End point timeframe
    During treatment until ed of follow up (2 years max.)
    End point values
    		 A (Calibration Arm) B (Vaccination arm) ITT
    Number of subjects analysed
    22
    46
    68
    Units: %
    number (not applicable)
        CR
    23
    11
    15
        PR
    36
    22
    26
        SD
    9
    20
    16
        PD
    32
    48
    43
    No statistical analyses for this end point

    Secondary: Duration of follow-up (ITT)

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    End point title
    		 Duration of follow-up (ITT)
    End point description
    The average and median documented duration of follow-up since randomisation is slightly shorter than one year, ranging up to 28.7 months, and quite similar in both study arms.
    End point type
    Secondary
    End point timeframe
    Duration of follow-up since randomisation
    End point values
    		 A (Calibration Arm) B (Vaccination arm) ITT
    Number of subjects analysed
    25
    50
    75
    Units: Months
        arithmetic mean (standard deviation)
    11.7 ( 8.4 )
    11.1 ( 6.2 )
    11.3 ( 6.9 )
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Subgroup of patients achieving CR or PR
    End point type
    Secondary
    End point timeframe
    Time from randomisation to the detection of progressive disease (or censoring)
    End point values
    		 A (Calibration Arm) B (Vaccination arm)
    Number of subjects analysed
    13
    15
    Units: Months
        number (not applicable)
    6.8
    9.5
    Attachments
    		 Duration of Response (ITT)
    Statistical analysis title
    		 Duration of Response
    Comparison groups
    A (Calibration Arm) v B (Vaccination arm)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Based on a total of as yet 46 observed deaths in the ITT population of 75 patients.
    End point type
    Secondary
    End point timeframe
    From the time point of randomisation until death
    End point values
    		 A (Calibration Arm) B (Vaccination arm)
    Number of subjects analysed
    25
    50
    Units: Months
        median (confidence interval 95%)
    13.1 (7.7 to 18.1)
    12.6 (9.5 to 19.6)
    Attachments
    		 Overall Survival (ITT)
    Statistical analysis title
    		 Overall Survival
    Comparison groups
    A (Calibration Arm) v B (Vaccination arm)
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.53
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 2.32

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event occurring between Visit 1 and until 3 months after EOT has to be reported.
    Adverse event reporting additional description
    All subjects received at least one dose of study treatment were analysed for safety.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    A (Calibration Arm)
    Reporting group description
    		 Patients recived pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.

    Reporting group title
    B (Vaccination arm)
    Reporting group description
    		 Patients received three UV1 vaccinations the week before initiation of pembrolizumab followed by 5 additional UV1 vaccinations every 3 weeks. Patients received pembrolizumab until disease progression (or other discontinuation criteria) and up to a maximum of two years.

    Serious adverse events
    		 A (Calibration Arm) B (Vaccination arm)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 25 (40.00%)
    28 / 50 (56.00%)
         number of deaths (all causes)
    14
    32
         number of deaths resulting from adverse events
    2
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Laryngeal cancer
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to liver
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal haemorrhage
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastrostomy failure
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis bullous
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin reaction
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Candida infection
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 A (Calibration Arm) B (Vaccination arm)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    47 / 50 (94.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour haemorrhage
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    1
    3
    Tumour pain
         subjects affected / exposed
    0 / 25 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    6
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 25 (20.00%)
    6 / 50 (12.00%)
         occurrences all number
    5
    7
    Injection site erythema
         subjects affected / exposed
    0 / 25 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    5
    Mucosal inflammation
         subjects affected / exposed
    0 / 25 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    0
    7
    Oedema
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 25 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    5
    Pain
         subjects affected / exposed
    6 / 25 (24.00%)
    3 / 50 (6.00%)
         occurrences all number
    6
    3
    Pyrexia
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 50 (4.00%)
         occurrences all number
    2
    2
    Dyspnoea
         subjects affected / exposed
    2 / 25 (8.00%)
    9 / 50 (18.00%)
         occurrences all number
    2
    11
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    4
    0
    C-reactive protein increased
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 50 (8.00%)
         occurrences all number
    2
    4
    Weight decreased
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 50 (2.00%)
         occurrences all number
    3
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    1
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 25 (4.00%)
    5 / 50 (10.00%)
         occurrences all number
    1
    5
    Leukopenia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Ascites
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 50 (4.00%)
         occurrences all number
    2
    2
    Dysphagia
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 50 (4.00%)
         occurrences all number
    3
    3
    Nausea
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 50 (8.00%)
         occurrences all number
    1
    4
    Salivary hypersecretion
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    1
    3
    Erythema
         subjects affected / exposed
    0 / 25 (0.00%)
    6 / 50 (12.00%)
         occurrences all number
    0
    9
    Pruritus
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 50 (8.00%)
         occurrences all number
    1
    4
    Rash
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 50 (6.00%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Back pain
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    1
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    2
    3
    Pneumonia
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 50 (6.00%)
         occurrences all number
    3
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 50 (8.00%)
         occurrences all number
    2
    6
    Hypocalcaemia
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 50 (2.00%)
         occurrences all number
    6
    3
    Hyponatraemia
         subjects affected / exposed
    4 / 25 (16.00%)
    3 / 50 (6.00%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38384801
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    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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