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YF-INFECT: Yellow Fever Human Infection Model With YF-17D

Sponsor
Leiden University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05901454
Collaborator
The International Society of Travel Medicine (Other)
30
Enrollment
1
Location
1
Arm
12.4
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Yellow Fever Vaccine
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readouthuman infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Yellow Fever Human Infection Model With YF-17D
Actual Study Start Date :
Feb 17, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leiden University Medical Center Leiden Netherlands 2333ZA

    Sponsors and Collaborators

    • Leiden University Medical Center
    • The International Society of Travel Medicine

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna HE Roukens, Principal Investigator, Leiden University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05901454
    Other Study ID Numbers:
    • NL70951.058.19
    First Posted:
    Jun 13, 2023
    Last Update Posted:
    Jun 13, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Yellow Fever
    Fever
    Vaccines

    Study Results

    No Results Posted as of Jun 13, 2023