Background The EDCTP-funded PREV_PKDL project was designed to: i) advance the clinical development of a vaccine for prevention of visceral leishmaniasis (VL)/post kala azar dermal leishmaniasis (PKDL) and ii) to gain a greater understanding of the immune determinants of treatment outcome, using multidimensional, multiparameter phenotyping of patient cohorts recruited across the countries of the Leishmaniasis East Africa Platform (LEAP; Ethiopia, Kenya, Sudan and Uganda). Central to the latter objective was the establishment of a distributed Center of Excellence in Flow Cytometry across the collaborating sites (Ethiopia, Kenya, Sudan Uganda and UK).

Methods Accomplishing the project objectives required acquisition of specialised equipment (CytoFLEX LX Cytometer), sourcing and validation of custom antibody panels, specialised training of flow cytometry managers, and renovation of space to develop a Flow Cytometry Laboratory. Study approvals were obtained for implementation at Kimalel and Chemolingot subcounty hospitals in Baringo County.

Results Multifaceted challenges were numerous, including delays in laboratory allocation and renovation, UK VISA issues precluding travel of the flow manager, supply chain delays occasioned by government requirements, late arrival of equipment, relocation of personnel and equipment from initial study site to current site, in-country insecurity and an ongoing curfew in the study area due to cattle rustling. Despite these challenges, the study has been initiated and high quality immunological data obtained from 24% of the target sample size. In addition, six Leishmania isolates have been obtained from splenic aspirates of VL patients enrolled as part of a nested collaboration that seeks to understand how parasite genotype affects clinical status and treatment response.

Conclusion Developing the capacity to conduct in depth immune phenotyping of patients enrolled in clinical studies in East Africa faces many hurdles that can be overcome by perseverance and a common objective.

Funding: This project is part of the EDCTP2 Programme supported by the European Union (RIA2016V-1640).