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A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal, subcutaneous and intramuscular yellow fever vaccination

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514154-73-00
Enrollment
222
Registered
2024-09-13
Start date
2025-01-02
Completion date
Unknown
Last updated
2025-07-24

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

Conditions

Yellow fever

Brief summary

The percentage of YFV-specific T cells within the skin-resident lymphocyte parent population at D28, measured by flow cytometry., The absolute number of YFV-specific T cells within the skin-resident lymphocyte parent population at D28, measured by flow cytometry.

Detailed description

Percentage and absolute number of circulating and YFV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at D28, and increase in their percentage and absolute number from D0 to D28., Percentage and absolute number of YFV-specific TRM, TCM and TEM CD4+ and CD8+ T cells within the skin-resident or CD3+ lymphocyte parent population at D28., The serum dilutions at which 50% viral neutralization occurs (NT50) as measured by the certified VNT (virus neutralization test) assays at D28, and the increase in their percentage and absolute number from D0 to D28., The nAbs NT50 titres, IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU at D0, D14, D28 and D120 measured by VNT and ELISpot/fluorospot respectively., At all timepoints, the NT50 of VNT testing and IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU. In addition at D0 and D28 , the percentage and absolute number of YFV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population., The occurrence of solicited and unsolicited local Adverse Events (AEs) [Up to Day 28 after vaccination], The occurrence of solicited and unsolicited systemic AEs [Up to Day 28 after vaccination], The occurrence of Serious Adverse Events (SAE’s) [Up to D120], The occurrence of solicited and unsolicited local Adverse Events (AEs) [Up to Day 28 after vaccination], The occurrence of solicited and unsolicited systemic AEs [Up to Day 28 after vaccination], The absolute number of YFV-specific TRM, TCM and TEM cells at D28

Interventions

DRUGpoeder en oplosmiddel voor suspensie voor injectie in voorgevulde spuit. Gelekoortsvaccin (levend).

Sponsors

Institute Of Tropical Medicine
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The percentage of YFV-specific T cells within the skin-resident lymphocyte parent population at D28, measured by flow cytometry., The absolute number of YFV-specific T cells within the skin-resident lymphocyte parent population at D28, measured by flow cytometry.

Secondary

MeasureTime frame
Percentage and absolute number of circulating and YFV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at D28, and increase in their percentage and absolute number from D0 to D28., Percentage and absolute number of YFV-specific TRM, TCM and TEM CD4+ and CD8+ T cells within the skin-resident or CD3+ lymphocyte parent population at D28., The serum dilutions at which 50% viral neutralization occurs (NT50) as measured by the certified VNT (virus neutralization test) assays at D28, and the increase in their percentage and absolute number from D0 to D28., The nAbs NT50 titres, IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU at D0, D14, D28 and D120 measured by VNT and ELISpot/fluorospot respectively., At all timepoints, the NT50 of VNT testing and IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU. In addition at D0 and D28 , the percentage and absolute number of YFV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population., The occur

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026