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Clinical Trials/NCT05901454
NCT05901454
Recruiting
Not Applicable

Yellow Fever Human Infection Model With YF-17D

Leiden University Medical Center1 site in 1 country30 target enrollmentFebruary 17, 2023

Overview

Phase
Not Applicable
Intervention
Yellow Fever Vaccine
Conditions
Yellow Fever
Sponsor
Leiden University Medical Center
Enrollment
30
Locations
1
Primary Endpoint
yellow fever 17D in urine
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2023
End Date
March 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Leiden University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Anna HE Roukens

Principal Investigator

Leiden University Medical Center

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

Arms & Interventions

intervention arm

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

Intervention: Yellow Fever Vaccine

Outcomes

Primary Outcomes

yellow fever 17D in urine

Time Frame: within 30 days of the vaccination

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

Secondary Outcomes

  • peak of YF 17D viruria after vaccination(within 30 days of the vaccination)
  • YF-17D viremia (in plasma) after vaccination(within 14 days of the vaccination)

Study Sites (1)

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