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

Study Overview
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Brief Summary
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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
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CD: cluster of differentiation YF: yellow fever

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

Conditions
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Healthy, Cytotoxicity, Yellow Fever Vaccination Reaction

Intervention / Treatment
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* Drug: Yellow Fever Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vaccine<br>Yellow Fever Vaccine | Drug: Yellow Fever Vaccine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing | Measured by polymerase chain reaction | 21(+/-3) days | 
| % of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing | Measured by polymerase chain reaction | 100 (+/- 40) days | 
| Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells | Measured by ex vivo killing assay | 21(+/-3) days | 
| Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells | Measured by ex vivo killing assay | 100 (+/- 40) days |