Table 3. Establishing a controlled human schistosome infection model in Uganda: key recommendations and next steps.

(CHI-S) - Controlled human infection model for Schistosoma mansoni, (GCLP) - Good Clinical Laboratory Practice.

Technical steps
Managing and shedding snails in Uganda	•   Establish GCLP level facility for housing and shedding snails in Uganda •   Obtain accreditation of facility
Identifying male cercariae and preparing inoculum	•   Training Uganda team in technical and quality control and quality assurance procedures
Detection and quantification of schistosome infection in Uganda	•   Implementation of the highly sensitive CAA assay in Uganda
Shipping infected snails to Uganda	•   Risk assessment regarding environmental contamination •   Implementation of risk management measures •   Implementation of IATA shipping requirements •   Ensuring Material Transfer Agreements are in place prior to shipment •   Planning for efficient release by customs officials and handling agents on arrival
Role of endemic CHI-S	•   Liaise with vaccine developers to position endemic CHI-S in the vaccine development pipeline
Community and participant recruitment steps
Community engagement	•   Raise awareness for CHI in local communities to ensure understanding and support •   Identify engaged communities who would be willing to participate •   Include details of planned community engagement (from parliament to local council) in protocol; undertake further preparatory engagement activities
Informed consent	•   With social science support, develop tools to ensure and document full understanding by participants •   Evaluate the informed consent process and assess the understanding of the study procedures
Management of natural exposure	•   Determine feasibility for potential participants of avoiding natural exposure to S. mansoni Infection during participation in the challenge model
Ethical and regulatory steps
Regulatory capacity building	•   Provide further information for ethicists and regulators and ethicists through visits to the Leiden facilities •   Liaise with African ethicists with previous CHI experience
CHI-S protocol for Uganda	•   Draft protocol; pre-submission discussions with regulatory authorities
CHI-S product dossier	•   Development of CHI-S product dossier and related documentation for Uganda