Table 2. Benchmarks identified in the Malawi framework, and approach to addressing them for the Uganda controlled human infection model for Schistosoma mansoni (CHI-S).

DSMB - data and safety monitoring board.

	Malawi framework benchmarks		Uganda CHI-S
1	Issue of national importance, within the research agenda		✓   Over half of Uganda’s population estimated to be at risk from schistosomiasis; vaccine development research supported by Vector Control Division (VCD), Ministry of Health
2	Safety already demonstrated		✓   Safety data from Leiden trials  ✓   Risk assessments to Uganda to be developed
3	Model quality established by published data		✓   Publication of Leiden trials expected in 2018
4	Strong scientific case, without alternative approach		✓   Model has potential to fast-track selection of best vaccine candidates accelerating development of safe, effective vaccines  ✓   Available animal models may not determine correlates of protection and vaccine efficacy in humans  ✓   Understanding and data needed regarding differences between endemic and non-endemic populations in response to candidate vaccines
5	Promotes capacity development in country		✓   CHI-S preparatory activities already providing opportunities for learning and debate for researchers, ethicists and regulators; continuing interaction between researchers and regulators is planned  ✓   Further developments to include relevant infrastructure development and technical training of Ugandan researchers
6	Ethical acceptability including issues of understanding consent		✓   Issues of understanding and voluntariness recognised and to be assured by pilot work in target populations in preparation for CHI-S
7	Governance structure in place (DSMB, sponsor)		✓   Protocol to be developed with due attention to these requirements