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NCT04083430 Clinical Trial

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

Healthy Clinical Trial

— CYF-8  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04083430
Other study ID # YFV_001
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date October 8, 2019
Est. completion date December 15, 2025

Study information
Verified date April 2024
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

CD: cluster of differentiation YF: yellow fever

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
Est. completion date December 15, 2025
Est. primary completion date February 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Yellow Fever Vaccine
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.

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 % 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
Secondary % 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
Secondary 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
Secondary 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
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