NCT07783243|RecruitingDMC
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
LEISHVAC
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LEISHVAC
Sponsor study identifier
observational
90
1 country
2
Study Start
May 26, 2026
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study assesses the immunoprevalence (presence of the induced T-cell response across different patients (and thus HLA types) of six prioritized IPX-derived Leishmania antigens, using Good Laboratory Practice-grade soluble Leishmania antigen (GLP-SLA) as a positive control. Longitudinal GLP-SLA stimulation validates its IFN-γ release assay performance to support licensing of a QuantiFERON-like test (Leish-IGRA) for treatment monitoring. IPX-derived Leishmania antigen screening focuses on day 0 and EOT, while GLP-SLA includes all timepoints. Induced T-cell responses by ex vivo stimulation of blood and tissue samples (lesion, bone marrow, or spleen) from patients with cutaneous and visceral leishmaniasis (two-centre cohort) before and after treatment will be verified. Samples from Ethiopian 'non-infected' healthy volunteers will be included in parallel to differentiate from Leishmania antigen-specific versus aspecific T-cell activation. The induced T-cell response will mainly be determined by the expressed IFN-γ levels after stimulation. Additional analyses are included to further characterize the activation and cytokine profiles of these IPX-derived Leishmania antigen-specific T-cells, while the breadth of the T-cell response will be determined by mapping the response across different patients (and thus different HLA types).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 15, 2026
Actual (reported)May 26, 2026
Actual (reported)August 24, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To determine the immunoprevalence of IPX-derived Leishmania antigens and their combinations in Ethiopian patients with VL and CL.
Proportion of patients that demonstrate an induced T-cell response (represented by IFN-γ expression) after ex vivo stimulation of IPX-derived antigens Leishmania and combinations.
"Day 0" (baseline) until "Day 17" or "Day 28" (end of treatment, may vary due to treatment)
To further characterize the phenotype (e.g., flow cytometry, single-cell sequencing) and polyfunctionality (multiplex cytokine determination) of the induced T-cell response after ex vivo stimulation with IPX-derived Leishmania antigens and GLP-SLA
"Day 0" (baseline) until "Day 17" or "Day 28" (end of treatment, may vary due to treatment)
Ethiopian population
Armauer Hansen Research Institute
Addis Ababa, Ethiopia
Leishmaniasis Research and Treatment Center
Gonder, Ethiopia
PBMCs (VL and CL) lesion biopsies (CL)
Thao-Thy Pham
Institute of Tropical Medicine Antwerp
Wim Adriaensen, PhD
Institute of Tropical Medicine Antwerp
Eshetu Molla, PhD
Armauer Hansen Research Institute, Ethiopia
Endalamaw Gadisa, PhD
Armauer Hansen Research Institute, Ethiopia
First Submitted
May 15, 2026
First Posted
August 24, 2026
Study Start
May 26, 2026
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Clinical Prognostic Score to Predict Relapse in VL
To compare the induced T-cell response of IPX-derived Leishmania antigens with GLP-SLA in blood versus tissues, by clinical presentation
"Day 0" (baseline) until "Day 17" or "Day 28" (end of treatment, may vary due to treatment)
To determine the dynamics of the induced T-cell response of IPX-derived Leishmania antigens versus GLP-SLA before and at end of successful versus failed treatment
"Day 0" (baseline) until "Day 17" or "Day 28" (end of treatment, may vary due to treatment)
To assess the predictive value of the Leish-IGRA for treatment outcome in CL and VL patients before, during and at end of treatment
"Day 0" (baseline), "Day 7", until "Day 17" or "Day 28" (end of treatment, may vary due to treatment)
To characterize the HLA-TCR interactions involved in the recognition of IPX-derived Leishmania antigens through TCR sequencing and HLA typing
"Day 0" (baseline) until "Day 17" or "Day 28" (end of treatment, may vary due to treatment)
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Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 24, 2026
Record last verified: 2026-08
IPD can be requested via the Data Access Committee of the Institute of Tropical Medicine Antwerp (https:// www. itg. be/ en/ resea rch/ data-shari ng-and-open-access) via a formal application and signed Data Sharing Agreement. In line with the study's data sharing policy, these datasets will be made available one year after completion of all planned primary publications.
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Source: ClinicalTrials.gov.
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