Yellow FeverYF-INFECTNCT05901454
Yellow Fever Human Infection Model With YF-17D
A study testing Yellow Fever Vaccine in people with Yellow Fever, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- What is being tested?
- Yellow Fever Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333ZA
Anna H Roukens, MD, PhD, +31715262613, a.h.e.roukens@lumc.nl
Leo G Visser, MD, PhD, +31715262613, l.g.visser@lumc.nl
About this study
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.
- Conditions
- Yellow Fever
- Being tested
- Yellow Fever Vaccine
- Medical subject headings
- Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow Fever VaccineDrug
Also called Stamaril (yellow fever vaccine)
vaccination according to manufacturers manual (0.5mL subcutaneously in the arm)
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Other | yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril) Receives: Drug: Yellow Fever Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
yellow fever 17D in urine
yellow fever 17D in urine at sequential time points after vaccination
Measured: within 30 days of the vaccination
Secondary outcomes (2)
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
Measured: within 30 days of the vaccination
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
Measured: within 14 days of the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start17 Feb 2023
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The International Society of Travel Medicine
- Responsible party
- Principal investigator, Anna HE Roukens, Leiden University Medical Center
- Investigators
- Anna HE Roukens, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901454
- Sponsor's protocol ID
- NL70951.058.19
- Acronym
- YF-INFECT
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: research protocol and data will be shared upon request according to the institution's (LUMC) policy
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yellow Fever Human Infection Model With YF-17D
- ClinicalTrials.gov ID
- NCT05901454
- Acronym / sponsor ID
- YF-INFECT / NL70951.058.19
- Conditions
- Yellow Fever
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- The International Society of Travel Medicine
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Other | Drug: Yellow Fever Vaccineyellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-50 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yellow Fever VaccineAlso: Stamaril (yellow fever vaccine)vaccination according to manufacturers manual (0.5mL subcutaneously in the arm) | Drug | intervention arm |
Primary outcome
yellow fever 17D in urine
Time frame: within 30 days of the vaccination
yellow fever 17D in urine at sequential time points after vaccination
2 secondary outcomes
peak of YF 17D viruria after vaccination
Time frame: within 30 days of the vaccination
YF-17D viremia (in plasma) after vaccination
Time frame: within 14 days of the vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No. research protocol and data will be shared upon request according to the institution's (LUMC) policy
Related trials for Yellow Fever
Active, not recruitingPhase 3
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Yellow Fever Immunization
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Antibiotics and Vaccine Immune Responses Study
Vaccine Response Impaired
Active, not recruitingPhase 2
Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA
Yellow Fever, Healthy Volunteers
Recruiting
Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants
Yellow Fever (Healthy Volunteers), Biopsy/Methods
RecruitingPhase 2
Improving Vaccine Protection for Adults
Immune System Responses and Trained Immunity After AS01 Administration, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna HE Roukens, MD PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yellow Fever Vaccine in people with Yellow Fever, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna H Roukens, MD, PhD (+31715262613, a.h.e.roukens@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
yellow fever 17D in urine (time frame: within 30 days of the vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.