A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal and intramuscular rabies vaccination < RABISKIMM >

Conditions

Rabies

Brief summary

The percentage and absolute number of skin-resident and RABV-specific T cells within the CD3+ lymphocyte parent population after booster vaccination at D120+14, measured by flow cytometry.

Detailed description

Percentage and absolute number of circulating and RABV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at D120+14, Percentage and absolute number of increase in RABV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population from D28 to D120+14, Percentage and absolute number of RABV-specific TRM, TCM and TEM CD4+ and CD8+ T cells within the CD3+ lymphocyte parent population at D28 and D120+14, and their percentage and absolute number of increase from D28 to D120+14, The geometric mean titres (GMTs) of neutralizing RRFIT test at D210+14, The nAbs GMT titres, IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU at D0, D7, D28, D120, D120+14, D120+90, measured by RRFIT and elispot/fluorospot respectively., At all timepoints, the geometric mean titres (GMTs) of neutralizing RRFIT test and IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU. In addition at D28 and D120+14, the percentage and absolute number of RABV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGRabipur poeder en oplosmiddel voor oplossing voor injectie in een voorgevulde spuit.Rabiësvaccin (geïnactiveerd).

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The percentage and absolute number of skin-resident and RABV-specific T cells within the CD3+ lymphocyte parent population after booster vaccination at D120+14, measured by flow cytometry.	—

Secondary

Measure	Time frame
Percentage and absolute number of circulating and RABV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at D120+14, Percentage and absolute number of increase in RABV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population from D28 to D120+14, Percentage and absolute number of RABV-specific TRM, TCM and TEM CD4+ and CD8+ T cells within the CD3+ lymphocyte parent population at D28 and D120+14, and their percentage and absolute number of increase from D28 to D120+14, The geometric mean titres (GMTs) of neutralizing RRFIT test at D210+14, The nAbs GMT titres, IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU at D0, D7, D28, D120, D120+14, D120+90, measured by RRFIT and elispot/fluorospot respectively., At all timepoints, the geometric mean titres (GMTs) of neutralizing RRFIT test and IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU. In addition at D28 and D120+14, the percentage and absolute number of RABV-specific TRM, TCM and TEM	—

Measure

Time frame

Percentage and absolute number of circulating and RABV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at D120+14, Percentage and absolute number of increase in RABV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population from D28 to D120+14, Percentage and absolute number of RABV-specific TRM, TCM and TEM CD4+ and CD8+ T cells within the CD3+ lymphocyte parent population at D28 and D120+14, and their percentage and absolute number of increase from D28 to D120+14, The geometric mean titres (GMTs) of neutralizing RRFIT test at D210+14, The nAbs GMT titres, IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU at D0, D7, D28, D120, D120+14, D120+90, measured by RRFIT and elispot/fluorospot respectively., At all timepoints, the geometric mean titres (GMTs) of neutralizing RRFIT test and IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU. In addition at D28 and D120+14, the percentage and absolute number of RABV-specific TRM, TCM and TEM

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Countries

Belgium

Outcome results

None listed