Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination

Phase 4

Active, not recruiting

• Conditions: Cytotoxicity; Healthy; Yellow Fever Vaccination Reaction
• Interventions: Drug: Yellow Fever Vaccine

• Registration Number: NCT04083430
• Lead Sponsor: University of Aarhus

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

Detailed Description

CD: cluster of differentiation YF: yellow fever

Study Timeline

• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-10
• Study Start: 2019-10-08
• Status Verified: 2024-04
• Primary Completion: 2025-02-15
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age between 18 to 60 years
• Informed consent given

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine	Yellow Fever Vaccine	Yellow Fever Vaccine

Primary Outcome Measures

Name	Time	Method
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D	21(+/-3) days	Measured by flow cytometry
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D	100 (+/- 40) days	Measured by flow cytometry

Secondary Outcome Measures

Name	Time	Method
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing	100 (+/- 40) days	Measured by polymerase chain reaction
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells	100 (+/- 40) days	Measured by ex vivo killing assay

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark