CClinicalTrials.gg
RecruitingNCT05901454YF-INFECTUpdated Jun 13, 2023

Yellow Fever Human Infection Model With YF-17D

An interventional study of Yellow Fever Vaccine in Yellow Fever, sponsored by Leiden University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Feb 2023, registered May 2023).
  • Started Feb 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Yellow Fever

Browse trials for

03

In context

Yellow Fever

60 studies on the registry are indexed under Yellow Fever; 12 are open to participants now.

This study's planned enrollment of 30 is below the median of 110 across 48 interventional studies indexed under Yellow Fever.

Browse Yellow Fever studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age 18-50 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    intervention arm

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

    Drug: Yellow Fever Vaccine

Interventions

  • DrugYellow Fever Vaccine

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

    Also known as: Stamaril (yellow fever vaccine)

06

What researchers measure

Primary outcomes

  1. yellow fever 17D in urine

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

    Time frame: within 30 days of the vaccination

Secondary outcomes

  1. 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

    Time frame: within 30 days of the vaccination

  2. YF-17D viremia (in plasma) after vaccination

    days after vaccination on which most participants have a positive yellow fever virus PCR on plasma as material

    Time frame: within 14 days of the vaccination

07

Study locations

1 of 1 sites recruiting
  • Leiden University Medical Center
    Leiden, 2333ZA, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — research protocol and data will be shared upon request according to the institution's (LUMC) policy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05901454
Lead sponsor
Leiden University Medical Center
Collaborators
The International Society of Travel Medicine
Responsible party
Anna HE Roukens (Principal Investigator, Leiden University Medical Center) — Principal investigator
First posted
Jun 13, 2023
Start date
Feb 17, 2023
Primary completion
Jul 1, 2023 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Jun 13, 2023

Study contacts

Anna H Roukens, MD, PhD
Contact
a.h.e.roukens@lumc.nl
+31715262613
Leo G Visser, MD PhD
Contact
l.g.visser@lumc.nl
+31715262613
Anna HE Roukens, MD PhD
principal investigator · Leiden University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion