Yellow Fever Human Infection Model With YF-17D

Not Applicable

Recruiting

• Conditions: Yellow Fever
• Interventions: Drug: Yellow Fever Vaccine

• Registration Number: NCT05901454
• Lead Sponsor: Leiden University Medical Center

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.

Study Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-05-23
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-13
• Last Update Posted: 2023-06-13
• Primary Completion: 2023-07-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention arm	Yellow Fever Vaccine	yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril)

Primary Outcome Measures

Name	Time	Method
yellow fever 17D in urine	within 30 days of the vaccination	yellow fever 17D in urine at sequential time points after vaccination

Secondary Outcome Measures

Name	Time	Method
peak of YF 17D viruria after vaccination	within 30 days of the 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	within 14 days of the vaccination	days after vaccination on which most participants have a positive yellow fever virus PCR on plasma as material

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands