HealthyPhase 4CYF-8NCT04083430
Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
A Phase 4 study testing Yellow Fever Vaccine in people with Healthy and Cytotoxicity, run by University of Aarhus at 1 site in Denmark.
Trial summary
Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cytotoxicity, Yellow Fever Vaccination Reaction
- 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
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Oct 2019to 15 Dec 2025
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 to 60 years
- Informed consent given
Who cannot join
- Fever (orally >37,5 C) on day of vaccination
- Immunosuppressants
- Pregnant or breast feeding
- Severe immunodeficiency
- Known thymus dysfunction
- Allergy against egg
Show all 9Show fewer
- Known haemophilia
- Previous severe reaction to vaccine
- Not willing to use anticonceptives 4 weeks after vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells
Read the detailed description
CD: cluster of differentiation YF: yellow fever
- Conditions
- Healthy, Cytotoxicity, Yellow Fever Vaccination Reaction
- Being tested
- Yellow Fever Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow Fever VaccineDrug
STAMARIL, powder and solvent for suspension for injection in pre-filled syringe.
After reconstitution, 1 dose (0.5 ml) contains: Yellow fever virus1 17D-204 strain (live, attenuated) not less than 1000 IU.
Powder and solvent for suspension for injection.
Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a limpid solution.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Other | Yellow Fever Vaccine Receives: Drug: Yellow Fever Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D
Measured by flow cytometry
Measured: 21(+/-3) days
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D
Measured by flow cytometry
Measured: 100 (+/- 40) days
Secondary outcomes (4)
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Measured by polymerase chain reaction
Measured: 21(+/-3) days
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Measured by polymerase chain reaction
Measured: 100 (+/- 40) days
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Measured by ex vivo killing assay
Measured: 21(+/-3) days
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Measured by ex vivo killing assay
Measured: 100 (+/- 40) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start8 Oct 2019
- Primary completion15 Feb 2025
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper D Gunst, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083430
- Sponsor's protocol ID
- YFV_001
- Acronym
- CYF-8
- Status last verified
- Apr 2024
- First submitted
- 2 Sep 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
- ClinicalTrials.gov ID
- NCT04083430
- Acronym / sponsor ID
- CYF-8 / YFV_001
- Conditions
- Healthy, Cytotoxicity, Yellow Fever Vaccination Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 10 Sep 2019 (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.
Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells
Detailed description
CD: cluster of differentiation YF: yellow fever
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Other | Drug: Yellow Fever VaccineYellow Fever Vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 to 60 years
- Informed consent given
Key exclusion criteria (9 listed)
- Fever (orally >37,5 C) on day of vaccination
- Immunosuppressants
- Pregnant or breast feeding
- Severe immunodeficiency
- Known thymus dysfunction
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 VaccineSTAMARIL, powder and solvent for suspension for injection in pre-filled syringe. After reconstitution, 1 dose (0.5 ml) contains: Yellow fever virus1 17D-204 strain (live, attenuated) not less than 1000 IU. Powder and solvent for suspension for injection. Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a limpid solution. | Drug | Vaccine |
Primary outcome
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D
Time frame: 21(+/-3) days
Measured by flow cytometry
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D
Time frame: 100 (+/- 40) days
Measured by flow cytometry
4 secondary outcomes
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Time frame: 21(+/-3) days
% of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
Time frame: 100 (+/- 40) days
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Time frame: 21(+/-3) days
Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
Time frame: 100 (+/- 40) days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- We have developed an immunotherapy technology in which potent CTL responses are generated in vivo by vaccination and redirected to eliminate target cells using a bispecific Redirector of Vaccine-induced Effector Responses (RoVER)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jesper D Gunst, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yellow Fever Vaccine in people with Healthy and Cytotoxicity, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 9 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 27 Mar 2025. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D (time frame: 21(+/-3) days). The study lists 2 primary outcomes in all. 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 27 Mar 2025.