Yellow Fever Human Infection Model With YF-17D | NCT05901454

Studies
Yellow Fever Human Infection Model With YF-17D

NCT05901454

Sponsor

Leiden University Medical Center

Status

Unknown status

Last Update Posted

Jun 13, 2023Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Yellow Fever

Interventions

Yellow Fever Vaccine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2023Actual

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Mar 1, 2024Estimated

First Submitted Date

May 23, 2023

First Submission Date that Met QC Criteria

Jun 12, 2023

First Posted Date

Jun 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2023

Last Update Posted Date

Jun 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anna HE Roukens, Principal Investigator, Leiden University Medical CenterPrincipal Investigator

Lead Sponsor

Leiden University Medical CenterOTHER

Collaborators

Name	Class
The International Society of Travel Medicine	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention arm	Other	yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril)	Drug: Yellow Fever Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yellow Fever Vaccine	Drug	vaccination according to manufacturers manual (0.5mL subcutaneously in the arm)	intervention arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
YF-17D viremia (in plasma) after vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Anna HE Roukens, MD PhD	Leiden University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center	Recruiting	Leiden		2333ZA	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015004	Yellow Fever

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D022341	Yellow Fever Vaccine

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided