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Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis

NCT07783243 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-08-24

No results posted yet for this study

Summary

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).

Conditions

  • Leishmaniasis, Cutaneous
  • Leishmaniasis
  • Leishmaniasis, Visceral
  • Immunogenicity

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • 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

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783243 on ClinicalTrials.gov