Back to resultsCytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination (CYF-8)
Primary Purpose
Healthy, Cytotoxicity, Yellow Fever Vaccination Reaction
Status
Enrolling by invitation
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Yellow Fever Vaccine
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vaccine
Arm Description
Yellow Fever Vaccine
Outcomes
Primary Outcome Measures
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D
Measured by flow cytometry
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D
Measured by flow cytometry
Secondary Outcome Measures
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Measured by polymerase chain reaction
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Measured by polymerase chain reaction
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Measured by ex vivo killing assay
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Measured by ex vivo killing assay
Full Information
NCT ID
NCT04083430
First Posted
September 2, 2019
Last Updated
May 9, 2023
Sponsor
University of Aarhus
Collaborators
Martin Tolstrup
1. Study Identification
Unique Protocol Identification Number
NCT04083430
Brief Title
Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
Acronym
CYF-8
Official Title
Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Martin Tolstrup
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Cytotoxicity, Yellow Fever Vaccination Reaction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Other
Arm Description
Yellow Fever Vaccine
Intervention Type
Drug
Intervention Name(s)
Yellow Fever Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D
Description
Measured by flow cytometry
Time Frame
21(+/-3) days
Title
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D
Description
Measured by flow cytometry
Time Frame
100 (+/- 40) days
Secondary Outcome Measure Information:
Title
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Description
Measured by polymerase chain reaction
Time Frame
21(+/-3) days
Title
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Description
Measured by polymerase chain reaction
Time Frame
100 (+/- 40) days
Title
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Description
Measured by ex vivo killing assay
Time Frame
21(+/-3) days
Title
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Description
Measured by ex vivo killing assay
Time Frame
100 (+/- 40) days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper D Gunst, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
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