Abstract
Schistosomiasis is a parasitic infection highly prevalent in sub-Saharan Africa, and a significant cause of morbidity; it is a priority for vaccine development. A controlled human infection model for Schistosoma mansoni (CHI-S) with potential to accelerate vaccine development has been developed among naïve volunteers in the Netherlands. Because responses both to infections and candidate vaccines are likely to differ between endemic and non-endemic settings, we propose to establish a CHI-S in Uganda where Schistosoma mansoni is endemic. As part of a "road-map" to this goal, we have undertaken a risk assessment. We identified risks related to importing of laboratory vector snails and schistosome strains from the Netherlands to Uganda; exposure to natural infection in endemic settings concurrently with CHI-S studies, and unfamiliarity of the community with the nature, risks and rationale for CHI. Mitigating strategies are proposed. With careful implementation of the latter, we believe that CHI-S can be implemented safely in Uganda. Our reflections are presented here to promote feedback and discussion.
Highlights
Any reports and responses or comments on the article can be found at the end of the article
In terms of the technical aspects of shipping infectious material to Uganda, culturing the infectious material in Uganda and preparing the infectious cercariae, we have considered three options
In this document we address risks associated with controlled human infection model for Schistosoma mansoni (CHI-S) in Uganda on three different levels: i) the introduction of new species, ii) the introduction of a new schistosome strain into Uganda, and iii) clinical trial risks common to all options
Summary
Available mitigations in several examples reduced our risk scores only to moderate, rather than low: for example, symptomatic treatment and early abrogation of infection cannot reduce the likelihood of symptoms below common, but can reduce the impact of the symptoms. Such areas emphasise the need for caution – for example, small group sizes and carefully monitored dose-escalation approaches. This project contains the following extended data: Appendix 1.docx (risk assessment report addressing the intended transfer to and culturing of the snail Biomphalaria glabrata in Uganda). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
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