CYF-8: Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
Sponsor
University of Aarhus (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04083430
Collaborator
Martin Tolstrup (Other)
80
1
1
28.3
2.8
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
CD: cluster of differentiation YF: yellow fever
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
Actual Study Start Date
:
Oct 8, 2019
Anticipated Primary Completion Date
:
Nov 15, 2021
Anticipated Study Completion Date
:
Feb 15, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Vaccine Yellow Fever Vaccine |
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- % 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
- % of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing [100 (+/- 40) 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
- Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells [100 (+/- 40) days]
Measured by ex vivo killing assay
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University Hospital | Aarhus | Denmark |
Sponsors and Collaborators
- University of Aarhus
- Martin Tolstrup
Investigators
- Principal Investigator: Jesper D Gunst, MD, Aarhus University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04083430
Other Study ID Numbers:
- YFV_001
First Posted:
Sep 10, 2019
Last Update Posted:
Oct 29, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: