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    Clinical Trial Results:
    Cytotoxicity of Yellow Fever specific CD8 T cells Following YF-17D Vaccination

    Summary
    EudraCT number
    		 2019-001731-31
    Trial protocol
    		 DK  
    Global end of trial date
    01 Sep 2024

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

    Trial information

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    Trial identification
    Sponsor protocol code
    YFV_001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04083430
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 45, Aarhus N, Denmark, 8200
    Public contact
    Jesper D. Gunst, Aarhus University Hospital, jesdam@rm.dk
    Scientific contact
    Jesper D. Gunst, Aarhus University Hospital, jesdam@rm.dk
    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
    01 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cytotoxicity of Yellow Fever specific CD8 T cells Following YF-17D Vaccination
    Protection of trial subjects
    1. At time of vaccination, no fever as measured by oral temp >37.5 C 2. At time of vaccination, not received immunosuppressive therapy 3. Pregnancy test prior to vaccination 4. Exclusion of persons with immune defect, thymic dysfunction, disease in the blood system, allergic reaction towards vaccines and egg allergy
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Aug 2019
    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
    Denmark: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Persons interested in vaccination against yellow fever was approached for participation

    Pre-assignment
    Screening details
    		 Exclusion and inclusion criteria was confirmed

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Vaccine arm
    Arm description
    		 Vaccination with the live-attenuated yellow fever (YF) YF-17D vaccine (Stamaril, Novartis) to study vaccine-induced YF epitope-specific CD8+ T cell (YF CTL) responses
    Arm type
    		 Experimental

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    a single dose of 0.5 mL 17D live-attenuated YF vaccine (Stamaril, Sanofi Pasteur)

    Number of subjects in period 1
    		Vaccine arm
    Started
    60
    Completed
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study period
    Reporting group description
    		 Healthy adult participants were recruited in the study (NCT04083430) and received vaccination with a single dose of 0.5 mL 17D live-attenuated YF vaccine (Stamaril, Sanofi Pasteur). Individuals self-reported any previous history of vaccination with YF-17D. Blood samples were taken (up to 100 days) prior to and at two timepoints (day 21 ± 3 and 100 ± 40) after vaccination

    Reporting group values
    		 Study period Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 26 (19 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Vaccine arm
    Reporting group description
    		 Vaccination with the live-attenuated yellow fever (YF) YF-17D vaccine (Stamaril, Novartis) to study vaccine-induced YF epitope-specific CD8+ T cell (YF CTL) responses

    Primary: Quantification of vaccine-induced YF CTLs

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    End point title
    		 Quantification of vaccine-induced YF CTLs [1]
    End point description
    End point type
    Primary
    End point timeframe
    April 2019 to September 2024
    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: These is purely a descriptive study
    End point values
    		 Vaccine arm
    Number of subjects analysed
    60
    Units: 79%
    60
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    April 2019 to September 2024
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 60 (11.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Syncope
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Groin pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1

    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.
    No major as this was descriptive

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37672868
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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