Yellow Fever Human Infection Model With YF-17D

NCT ID: NCT05901454

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2024-03-01

Brief Summary

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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

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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

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Yellow Fever

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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intervention arm

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

Group Type OTHER

Yellow Fever Vaccine

Intervention Type DRUG

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

Interventions

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Yellow Fever Vaccine

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

Intervention Type DRUG

Other Intervention Names

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Stamaril (yellow fever vaccine)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The International Society of Travel Medicine

UNKNOWN

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anna HE Roukens

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna HE Roukens, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Anna H Roukens, MD, PhD

Role: CONTACT

+31715262613

Leo G Visser, MD PhD

Role: CONTACT

+31715262613

Facility Contacts

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Anna H Roukens, MD, PhD

Role: primary

+31715262613

Leo G Visser, MD, PhD

Role: backup

+31715262613

Other Identifiers

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NL70951.058.19

Identifier Type: -

Identifier Source: org_study_id

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