Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination (CYF-8)
March 26, 2025 updated by: University of Aarhus
Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
CD: cluster of differentiation YF: yellow fever
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark
- Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Vaccine
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. |
What is the study measuring?
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
Time Frame: 21(+/-3) days
|
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
Time Frame: 100 (+/- 40) days
|
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
Time Frame: 21(+/-3) days
|
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
Time Frame: 100 (+/- 40) days
|
Measured by polymerase chain reaction
|
100 (+/- 40) days
|
|
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Time Frame: 21(+/-3) days
|
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
Time Frame: 100 (+/- 40) days
|
Measured by ex vivo killing assay
|
100 (+/- 40) days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jesper D Gunst, MD, Aarhus University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2019
Primary Completion (Actual)
February 15, 2025
Study Completion (Estimated)
December 15, 2025
Study Registration Dates
First Submitted
September 2, 2019
First Submitted That Met QC Criteria
September 5, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2025
Last Update Submitted That Met QC Criteria
March 26, 2025
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YFV_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.