Cytotoxicity, Healthy, Yellow Fever Vaccination Reaction
Conditions
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
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| % of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing | 21(+/-3) days | Measured by polymerase chain reaction |
| Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells | 21(+/-3) days | Measured by ex vivo killing assay |
Countries
Denmark