Title of article :
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
Author/Authors :
Elliott, Alison M. Medical Research Council - Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine (MRC/UVRI and LSHTM) - Uganda Research Unit, Entebbe, Uganda , Roestenberg, Meta Department of Parasitology - Leiden University Medical Center, Leiden, The Netherlands , Wajja, Anne Medical Research Council - Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine (MRC/UVRI and LSHTM) - Uganda Research Unit, Entebbe, Uganda , Opio, Christopher Department of Medicine - College of Health Sciences - Makerere University, Kampala, Uganda , Adriko, Moses Vector Control Division - Ministry of Health of Uganda, Kampala, Uganda , Egesa, Moses Medical Research Council - Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine (MRC/UVRI and LSHTM) - Uganda Research Unit, Entebbe, Uganda , Gitome, Serah Kenya Medical Research Institute (KEMRI), Nairobi, Kenya , Mfutso-Bengo, Joseph Centre for Bioethics for Eastern and Southern Africa - School of Public Health and Family Medicine - College of Medicine - University of Malawi, Blantyre, Malawi , Bejon, Philip KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya , Kapulu, Melissa KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya , Seager, Zoe Wellcome Trust, London, UK , Lutalo, Tom Uganda Virus Research Institute, Entebbe, Uganda , Nazziwa, Winfred Badanga Uganda National Council for Science and Technology, Kampala, Uganda , Muwumuza, Asuman Mukono District Local Government, Mukono, Uganda , Yazdanbakhsh, Maria Department of Parasitology - Leiden University Medical Center, Leiden, The Netherlands , Kaleebu, Pontiano Medical Research Council - Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine (MRC/UVRI and LSHTM) - Uganda Research Unit, Entebbe, Uganda , Kabatereine, Narcis Vector Control Division - Ministry of Health of Uganda, Kampala, Uganda , Tukahebwa, Edridah Vector Control Division - Ministry of Health of Uganda, Kampala, Uganda
Pages :
20
From page :
1
To page :
20
Abstract :
Controlled 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.
Keywords :
Controlled human infection model , Schistosoma mansoni , Uganda , The Netherlands
Journal title :
AAS Open Research
Serial Year :
2018
Full Text URL :
Record number :
2612246
Link To Document :
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