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Yellow Fever Human Infection Model With YF-17D (YF-INFECT)

Primary Purpose

Yellow Fever

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Yellow Fever Vaccine
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Yellow Fever

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age 18-50 years Exclusion Criteria: contraindication to receive YF-17D (immune deficiency, thymus illness) previous YF vaccination pregnancy chicken egg allergy hypersensitivity to any other substance in the YF-17D vaccine interval of < 4 weeks of another live attenuated vaccine

Sites / Locations

  • Leiden University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

intervention arm

Arm Description

yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril)

Outcomes

Primary Outcome Measures

yellow fever 17D in urine
yellow fever 17D in urine at sequential time points after vaccination

Secondary Outcome Measures

peak of YF 17D viruria after vaccination
days after vaccination on which most participants have a positive yellow fever virus PCR on urine as material
YF-17D viremia (in plasma) after vaccination
days after vaccination on which most participants have a positive yellow fever virus PCR on plasma as material

Full Information

First Posted
May 23, 2023
Last Updated
June 12, 2023
Sponsor
Leiden University Medical Center
Collaborators
The International Society of Travel Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05901454
Brief Title
Yellow Fever Human Infection Model With YF-17D
Acronym
YF-INFECT
Official Title
Yellow Fever Human Infection Model With YF-17D
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
The International Society of Travel Medicine

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
No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.
Detailed Description
No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yellow Fever

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Other
Arm Description
yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril)
Intervention Type
Drug
Intervention Name(s)
Yellow Fever Vaccine
Other Intervention Name(s)
Stamaril (yellow fever vaccine)
Intervention Description
vaccination according to manufacturers manual (0.5mL subcutaneously in the arm)
Primary Outcome Measure Information:
Title
yellow fever 17D in urine
Description
yellow fever 17D in urine at sequential time points after vaccination
Time Frame
within 30 days of the vaccination
Secondary Outcome Measure Information:
Title
peak of YF 17D viruria after vaccination
Description
days after vaccination on which most participants have a positive yellow fever virus PCR on urine as material
Time Frame
within 30 days of the vaccination
Title
YF-17D viremia (in plasma) after vaccination
Description
days after vaccination on which most participants have a positive yellow fever virus PCR on plasma as material
Time Frame
within 14 days of the vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18-50 years Exclusion Criteria: contraindication to receive YF-17D (immune deficiency, thymus illness) previous YF vaccination pregnancy chicken egg allergy hypersensitivity to any other substance in the YF-17D vaccine interval of < 4 weeks of another live attenuated vaccine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna H Roukens, MD, PhD
Phone
+31715262613
Email
a.h.e.roukens@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Leo G Visser, MD PhD
Phone
+31715262613
Email
l.g.visser@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna HE Roukens, MD PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna H Roukens, MD, PhD
Phone
+31715262613
Email
a.h.e.roukens@lumc.nl
First Name & Middle Initial & Last Name & Degree
Leo G Visser, MD, PhD
Phone
+31715262613
Email
l.g.visser@lumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
research protocol and data will be shared upon request according to the institution's (LUMC) policy

Learn more about this trial

Yellow Fever Human Infection Model With YF-17D

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