Clinical trial

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

Name

YFV_001

Description

Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells

Trial arms

Trial start

2019-10-08

Estimated PCD

2025-02-15

Trial end

2025-12-15

Phase

Early phase I

Treatment

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.

Arms:

Vaccine

Size

Primary endpoint

Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D

21(+/-3) days

Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D

100 (+/- 40) days

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-04-18

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication