Immune respons following vaccination against yellow fever

Cytotoxicity of Yellow Fever specific CD8 T cells Following YF-17D Vaccination - CYF8

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001731-31-DK

Enrollment

Registered

2019-06-06

Start date

2019-09-02

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy individuals or HIV-1 infected individuals MedDRA version: 22.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Stamaril Product Name: Stamaril Pharmaceutical Form: Powder and solvent for suspension for injection in pre-filled syringe INN or Proposed INN: live attenuated yellow fever virus Other des

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: At vaccination (every participant) - Age between 18 to 60 years - Ability to give informed consent At screening (HIV-1 infection) - CD4+ T cell count >350 cells/mm3 - Plasma HIV-1 RNA levels =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: At vaccination (every participant) - Fever orally (>37,5 C) - On imunosuppresive therapy - Pregnant or breastfeeding (urine hcg will be performed) - Severe immunodeficiency (not HIV-1 infection) - Thymus dysfunction - Egg allergy - Bleeding disorder - Previous allergic reaction to vaccination

Design outcomes

Primary

Measure	Time frame
Main Objective: Cytotoxicity of Yellow Fever specific CD8 T cells Following YF-17D Vaccination;Secondary Objective: - To identify immunodominant epitopes - To investigate effect of HLA-type on immune response - To discover novel yellow fever vaccine epitopes and to define the optimal time-window for CD8+ T cell licensing - To provide proof that in vivo generated virus-specific CD8+ T cells can be licensed to kill target cells ex vivo - Investigate cytotoxicity of virus-specific cells in an adoptive-transfer study in humanized mice ;Primary end point(s): Cytotoxicity of virus-specific (NS4B 214LLWNGPMAV222) CD8+ T cells in peripheral blood;Timepoint(s) of evaluation of this end point: - 21±3 after vaccination - 100±40 after vaccination	—

Measure

Time frame

Main Objective: Cytotoxicity of Yellow Fever specific CD8 T cells Following YF-17D Vaccination;Secondary Objective: - To identify immunodominant epitopes - To investigate effect of HLA-type on immune response - To discover novel yellow fever vaccine epitopes and to define the optimal time-window for CD8+ T cell licensing - To provide proof that in vivo generated virus-specific CD8+ T cells can be licensed to kill target cells ex vivo - Investigate cytotoxicity of virus-specific cells in an adoptive-transfer study in humanized mice ;Primary end point(s): Cytotoxicity of virus-specific (NS4B 214LLWNGPMAV222) CD8+ T cells in peripheral blood;Timepoint(s) of evaluation of this end point: - 21±3 after vaccination - 100±40 after vaccination

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Secondary

Measure	Time frame
Secondary end point(s): - To identify immunodominant epitopes with focus on HLAA1, A2, B7 and B35 - Licensing generated virus-specific CD8+ T cells to kill target cells ex vivo - Licensing generated virus-specific CD8+ T cells to kill target cellsin in vivo (adoptive transfer study in humanized mice);Timepoint(s) of evaluation of this end point: - 21±3 after vaccination - 100±40 after vaccination	—

Measure

Time frame

Secondary end point(s): - To identify immunodominant epitopes with focus on HLA*A1, *A2, *B7 and *B35 - Licensing generated virus-specific CD8+ T cells to kill target cells ex vivo - Licensing generated virus-specific CD8+ T cells to kill target cellsin in vivo (adoptive transfer study in humanized mice);Timepoint(s) of evaluation of this end point: - 21±3 after vaccination - 100±40 after vaccination

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Countries

Denmark

Contacts

Public ContactClinical Trial Information

Aarhus University Hospital

jesdam@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026