Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
CYF-8
1 other identifier
interventional
60
1 country
1
Brief Summary
Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 healthy
Started Oct 2019
Longer than P75 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedMarch 27, 2025
April 1, 2024
5.4 years
September 2, 2019
March 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D
Measured by flow cytometry
21(+/-3) days
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D
Measured by flow cytometry
100 (+/- 40) days
Secondary Outcomes (4)
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
21(+/-3) days
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
100 (+/- 40) days
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
21(+/-3) days
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
100 (+/- 40) days
Study Arms (1)
Vaccine
OTHERYellow Fever Vaccine
Interventions
STAMARIL, powder and solvent for suspension for injection in pre-filled syringe. After reconstitution, 1 dose (0.5 ml) contains: Yellow fever virus1 17D-204 strain (live, attenuated) not less than 1000 IU. Powder and solvent for suspension for injection. Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a limpid solution.
Eligibility Criteria
You may qualify if:
- Age between 18 to 60 years
- Informed consent given
You may not qualify if:
- Fever (orally \>37,5 C) on day of vaccination
- Immunosuppressants
- Pregnant or breast feeding
- Severe immunodeficiency
- Known thymus dysfunction
- Allergy against egg
- Known haemophilia
- Previous severe reaction to vaccine
- Not willing to use anticonceptives 4 weeks after vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, Denmark
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper D Gunst, MD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2019
First Posted
September 10, 2019
Study Start
October 8, 2019
Primary Completion
February 15, 2025
Study Completion
December 15, 2025
Last Updated
March 27, 2025
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share