Yellow Fever Human Infection Model With YF-17D

NCT05901454 | Unknown

• 1 other identifier: NL70951.058.19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Yellow Fever

Outcome Measures

Primary Outcomes (1)

• yellow fever 17D in urine

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

  within 30 days of the vaccination

Secondary Outcomes (2)

• 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 Arms (1)

intervention arm

OTHER

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

Drug: Yellow Fever Vaccine

Interventions

Yellow Fever Vaccine DRUG

vaccination according to manufacturers manual (0.5mL subcutaneously in the arm)

Also known as: Stamaril (yellow fever vaccine)

intervention arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-50 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• The International Society of Travel Medicine: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Yellow Fever

Interventions

Yellow Fever Vaccine

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Anna HE Roukens, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna H Roukens, MD, PhD

CONTACT

+31715262613; a.h.e.roukens@lumc.nl

Leo G Visser, MD PhD

CONTACT

+31715262613; l.g.visser@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 13, 2023
• Study Start: February 17, 2023
• Primary Completion: July 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)