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NCT05901454 Clinical Trial

Yellow Fever Human Infection Model With YF-17D

Yellow Fever Clinical Trial

— YF-INFECT  

Official title:
Yellow Fever Human Infection Model With YF-17D

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05901454
Other study ID # NL70951.058.19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 17, 2023
Est. completion date March 1, 2024

Study information
Verified date June 2023
Source Leiden University Medical Center
Contact Anna H Roukens, MD, PhD
Phone +31715262613
Email a.h.e.roukens@lumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date March 1, 2024
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Yellow Fever Vaccine
vaccination according to manufacturers manual (0.5mL subcutaneously in the arm)

Locations
Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (2)
Lead Sponsor Collaborator
Leiden University Medical Center The International Society of Travel Medicine

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary yellow fever 17D in urine yellow fever 17D in urine at sequential time points after vaccination within 30 days of the vaccination
Secondary 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 within 30 days of the vaccination
Secondary 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 within 14 days of the vaccination
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