Ethical and Scientific Considerations on the Establishment of a Controlled Human Infection Model for Schistosomiasis in Uganda: report of a stakeholders’ meeting held in Entebbe, Uganda.

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dc.contributor.authorElliott, Alison M.
dc.contributor.authorWajja, Anne
dc.contributor.authorOpio, Christopher
dc.contributor.authorAngumya, Francis
dc.contributor.authorAdriko, Moses
dc.contributor.authorEgesa, Moses
dc.contributor.authorMfutso-Bengo, Joseph
dc.contributor.authorKapulu, Melissa
dc.contributor.authorLutalo, Tom
dc.contributor.authorNazziwa, Winfred Badanga
dc.contributor.authorMuwumuza, Asuman
dc.contributor.authorKaleebu, Pontiano
dc.contributor.authorKabatereine, Narcis
dc.contributor.authorTukahebwa, Edridah
dc.date.accessioned2023-06-26T17:14:16Z
dc.date.available2023-06-26T17:14:16Z
dc.date.issued2018
dc.description.abstractControlled human infection (CHI) models are gaining recognition as an approach to accelerating vaccine development, for use in both non-endemic and endemic populations: they can facilitate identification of the most promising candidate vaccines for further trials and advance understanding of protective immunity. Helminths present a continuing health burden in sub-Saharan Africa. Vaccine development for these complex organisms is particularly challenging, partly because protective responses are akin to mechanisms of allergy. A CHI model for Schistosoma mansoni (CHI-S) has been developed at Leiden University Medical Centre, the Netherlands. However, responses to schistosome infections, and candidate vaccines, are likely to be different among people from endemic settings compared to schistosome-naïve Dutch volunteers. Furthermore, among volunteers from endemic regions who have acquired immune responses through prior exposure, schistosome challenge can be used to define responses associated with clinical protection, and thus to guide vaccine development. To explore the possibility of establishing the CHI-S in Uganda, a Stakeholders’ Meeting was held in Entebbe in 2017. Regulators, community members, researchers and policy-makers discussed implementation challenges and recommended preparatory steps: risk assessment; development of infrastructure and technical capacity to produce the infectious challenge material in Uganda; community engagement from Parliamentary to grass-roots level; pilot studies to establish approaches to assuring fully informed consent and true voluntariness, and strategies for selection of volunteers who can avoid natural infection during the 12-week CHI-S; the building of regulatory capacity; and the development of study protocols and a product dossier in close consultation with ethical and regulatory partners. It was recommended that, on completion, the protocol and product dossier be reviewed for approval in a joint meeting combining ethical, regulatory and environment management authorities. Most importantly, representatives of schistosomiasis-affected communities emphasised the urgent need for an effective vaccine and urged the research community not to delay in the development process.en_US
dc.identifier.citationElliott, A. M., Roestenberg, M., Wajja, A., Opio, C., Angumya, F., Adriko, M., ... & Tukahebwa, E. (2018). Ethical and scientific considerations on the establishment of a controlled human infection model for schistosomiasis in Uganda: report of a stakeholders’ meeting held in Entebbe, Uganda. AAS open research, 1.https://doi.org/10.12688%2Faasopenres.12841.2en_US
dc.identifier.issn2752-6925
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/8992
dc.language.isoenen_US
dc.publisherAAS open researchen_US
dc.subjectControlled human infection modelen_US
dc.subjectSchistosoma mansonien_US
dc.subjectHelminthsen_US
dc.titleEthical and Scientific Considerations on the Establishment of a Controlled Human Infection Model for Schistosomiasis in Uganda: report of a stakeholders’ meeting held in Entebbe, Uganda.en_US
dc.typeArticleen_US
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