Immune respons following vaccination against yellow fever

Phase 1

• Conditions: Healthy individuals or HIV-1 infected individuals; MedDRA version: 22.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-001731-31-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-06
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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 <50 cps/ml for a minimum of 18 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Cytotoxicity of Yellow Fever specific CD8 T cells Following YF-17D Vaccination;Secondary Objective: - To identify immunodominant epitopes<br>- To investigate effect of HLA-type on immune response<br>- To discover novel yellow fever vaccine epitopes and to define the optimal time-window for CD8+ T cell licensing<br>- To provide proof that in vivo generated virus-specific CD8+ T cells can be licensed to kill target cells ex vivo<br>- Investigate cytotoxicity of virus-specific cells in an adoptive-transfer study in humanized mice<br>;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 <br>- 100±40 after vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - To identify immunodominant epitopes with focus on HLA*A1, *A2, *B7 and *B35<br>- Licensing generated virus-specific CD8+ T cells to kill target cells ex vivo<br>- 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 <br>- 100±40 after vaccination