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

June 12, 2023 updated by: Anna HE Roukens, Leiden University Medical Center
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: intervention arm
yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril)
Drug: Yellow Fever Vaccine
vaccination according to manufacturers manual (0.5mL subcutaneously in the arm)
Other Names:
  • Stamaril (yellow fever vaccine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
yellow fever 17D in urine
Time Frame: within 30 days of the vaccination
yellow fever 17D in urine at sequential time points after vaccination
within 30 days of the vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peak of YF 17D viruria after vaccination
Time Frame: within 30 days of the 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
YF-17D viremia (in plasma) after vaccination
Time Frame: within 14 days of the 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

The International Society of Travel Medicine

Investigators

  • Principal Investigator: Anna HE Roukens, MD PhD, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2023

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Estimated)

June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL70951.058.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

research protocol and data will be shared upon request according to the institution's (LUMC) policy

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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