Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination (CYF-8)

April 16, 2024 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

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

CD: cluster of differentiation YF: yellow fever

Study Type

Interventional

Enrollment (Estimated)

80

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

  • Denmark
      • 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
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.

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

University of Aarhus

Collaborators

Martin Tolstrup

Investigators

  • Principal Investigator: Jesper D Gunst, MD, Aarhus University Hospital

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 (Estimated)

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)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

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.

Clinical Trials on Healthy

Clinical Trials on Yellow Fever Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe