{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:06:26Z","timestamp":1772168786621,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/aasopenres.12972.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2019,8,13]],"date-time":"2019-08-13T00:00:00Z","timestamp":1565654400000}}],"reference-count":18,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2019,8,13]],"date-time":"2019-08-13T00:00:00Z","timestamp":1565654400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000268","name":"Biotechnology and Biological Sciences Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000268","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004440","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["107743"],"award-info":[{"award-number":["107743"]}],"id":[{"id":"10.13039\/100004440","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["aasopenresearch.org"],"crossmark-restriction":false},"short-container-title":["AAS Open Res"],"abstract":"<ns5:p>\n                    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\n                    <ns5:italic>Schistosoma mansoni<\/ns5:italic>\n                    (CHI-S) with potential to accelerate vaccine development has been developed among na\u00efve 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\n                    <ns5:italic>Schistosoma mansoni<\/ns5:italic>\n                    is endemic. As part of a \u201croad-map\u201d 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.\n                  <\/ns5:p>","DOI":"10.12688\/aasopenres.12972.2","type":"journal-article","created":{"date-parts":[[2019,8,13]],"date-time":"2019-08-13T06:40:06Z","timestamp":1565678406000},"page":"17","update-policy":"https:\/\/doi.org\/10.12688\/aasopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Risk assessment for the implementation of controlled human Schistosoma mansoni infection trials in Uganda"],"prefix":"10.12688","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1335-9402","authenticated-orcid":false,"given":"Jan Pieter","family":"Koopman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5136-868X","authenticated-orcid":false,"given":"Moses","family":"Egesa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Wajja","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9748-1207","authenticated-orcid":false,"given":"Moses","family":"Adriko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacent","family":"Nassuuna","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4062-9105","authenticated-orcid":false,"given":"Gyaviira","family":"Nkurunungi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1146-1964","authenticated-orcid":false,"given":"Emmanuella","family":"Driciru","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gijsbert","family":"van Willigen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5156-037X","authenticated-orcid":false,"given":"Stephen","family":"Cose","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Yazdanbakhsh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pontiano","family":"Kaleebu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Narcis","family":"Kabatereine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edridah","family":"Tukahebwa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5052-2830","authenticated-orcid":false,"given":"Meta","family":"Roestenberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2818-9549","authenticated-orcid":false,"given":"Alison M.","family":"Elliott","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2019,8,13]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"2253-64","DOI":"10.1016\/S0140-6736(13)61949-2","article-title":"Human schistosomiasis.","volume":"383","author":"D Colley","year":"2014","journal-title":"Lancet."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"16-9","DOI":"10.1126\/science.351.6268.16","article-title":"Unfilled Vials.","volume":"351","author":"J Cohen","year":"2016","journal-title":"Science."},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"1142-6","DOI":"10.1093\/infdis\/jiy275","article-title":"Establishing the Production of Male Schistosoma mansoni Cercariae for a Controlled Human Infection Model.","volume":"218","author":"J Janse","year":"2018","journal-title":"J Infect Dis."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"3147-58","DOI":"10.1172\/JCI75429","article-title":"Immune activation alters cellular and humoral responses to yellow fever 17D vaccine.","volume":"124","author":"E Muyanja","year":"2014","journal-title":"J Clin Invest."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"e637","DOI":"10.1371\/journal.pntd.0000637","article-title":"Influence of exposure history on the immunology and development of resistance to human Schistosomiasis mansoni.","volume":"4","author":"C Black","year":"2010","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-6","article-title":"Schistosomiasis Monitoring in Uganda Round 2, October\u2013December 2017","year":"2017"},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"1707-8","DOI":"10.1016\/S0140-6736(14)60817-5","article-title":"Uganda's struggle with schistosomiasis.","volume":"383","author":"S Loewenberg","year":"2014","journal-title":"Lancet."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"2","DOI":"10.12688\/aasopenres.12841.1","article-title":"Ethical and scientific considerations on the establishment of a controlled human infection model for schistosomiasis in Uganda: report of a stakeholders\u2019 meeting held in Entebbe, Uganda. [version 1; peer review: 2 approved].","volume":"1","author":"A Elliott","year":"2018","journal-title":"AAS Open Res."},{"key":"ref-9","article-title":"Controlled Human Infection Model - Schistosomiasis","author":"S Cose","year":"2019"},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"303-8","DOI":"10.1016\/j.actatropica.2013.02.014","article-title":"Compatibility of Ugandan Schistosoma mansoni isolates with Biomphalaria snail species from lake Albert and lake Victoria.","volume":"128","author":"M Adriko","year":"2013","journal-title":"Acta Tropdol."},{"key":"ref-11","article-title":"Guidance on regulations for the transport of infectious substances 2017-2018"},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"1136-46","DOI":"10.1111\/j.1558-5646.1991.tb04380.x","article-title":"Self-Fertilization Versus Cross-Fertilization in the Hermaphroditic Freshwater Snail Bulinus Globosus.","volume":"45","author":"P Jarne","year":"1991","journal-title":"Evolution."},{"key":"ref-13","doi-asserted-by":"publisher","first-page":"1151-9","DOI":"10.1093\/cid\/ciw506","article-title":"Reduced Efficacy of Praziquantel Against Schistosoma mansoni Is Associated With Multiple Rounds of Mass Drug Administration.","volume":"63","author":"T Crellen","year":"2016","journal-title":"Clin Infect Dis."},{"key":"ref-14","doi-asserted-by":"publisher","first-page":"e0005953","DOI":"10.1371\/journal.pntd.0005953","article-title":"Estimating sensitivity of the Kato-Katz technique for the diagnosis of Schistosoma mansoni and hookworm in relation to infection intensity.","volume":"11","author":"O Barenbold","year":"2017","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-15","doi-asserted-by":"publisher","first-page":"39","DOI":"10.12688\/wellcomeopenres.14439.2","article-title":"Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya [version 2; peer review: 2 approved].","volume":"3","author":"M Njue","year":"2018","journal-title":"Wellcome Open Res."},{"key":"ref-16","doi-asserted-by":"publisher","DOI":"10.7326\/L18-0438","article-title":"Katayama Syndrome Without Schistosoma mansoni Eggs.","author":"M Langenberg","year":"2019","journal-title":"Ann Intern Med."},{"key":"ref-17","doi-asserted-by":"publisher","first-page":"182","DOI":"10.1186\/s12936-015-0671-x","article-title":"Lessons learnt from the first controlled human malaria infection study conducted in Nairobi, Kenya.","volume":"14","author":"S Hodgson","year":"2015","journal-title":"Malar J."},{"key":"ref-18","doi-asserted-by":"publisher","first-page":"141","DOI":"10.12688\/wellcomeopenres.14668.2","article-title":"A Malawi guideline for research study participant remuneration.","volume":"3","author":"S Gordon","year":"2018","journal-title":"Wellcome Open Res."}],"container-title":["AAS Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,7,21]],"date-time":"2020-07-21T02:50:14Z","timestamp":1595299814000},"score":1,"resource":{"primary":{"URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,8,13]]},"references-count":18,"URL":"https:\/\/doi.org\/10.12688\/aasopenres.12972.2","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/aasopenres.14072.r27120","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/aasopenres.14072.r27120","asserted-by":"object"}]},"ISSN":["2515-9321"],"issn-type":[{"value":"2515-9321","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,8,13]]},"assertion":[{"value":"Indexed","URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/aasopenres.14053.r27005, James E. Meiring, Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi, 17 Jun 2019, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v1#referee-response-27005","order":0,"name":"referee-response-27005","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Alison Elliott<\/b>; \n<i>Posted: 05 Aug 2019<\/i>; Comment: In addition to what is presented here, I think it might be helpful for the authors to outline their thinking on expectations for financial reimbursement for participants who go through the trial in Uganda, and if there are any risks attached to this, as discussed in Gordon, S et al. 2018 published in Wellcome Open Research.Response: We agree that the financial reimbursement is an important topic for debate. We have thus added a paragraph on this matter and included it in the table with risks related to the controlled human infection with \n<i>Sm.<\/i>&nbsp;Comment: It may also be beneficial to consult the literature for other examples of CHI studies that have been moved from non-endemic, high income countries to endemic sites. Although the individual risks may be different, the general lessons may be applicable and helpful.Response: We agree that it will be essential to interact with experienced researchers who have implemented CHI studies in LMIC. We added reference to this important topic by addressing a paper on the first malaria CHI in Kenya that describes issues that are also applicable for our CHI-S.","URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v2#referee-comment-3116","order":1,"name":"referee-comment-3116","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/aasopenres.14072.r27120, Donald Harn, Department of Infectious Diseases, College of Veterinary Medicine, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, GA, USA, 21 Aug 2019, version 2, indexed","URL":"https:\/\/aasopenresearch.org\/articles\/2-17\/v2#referee-response-27120","order":2,"name":"referee-response-27120","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"The work was supported by a pump-priming grant from the HIC-Vac network. The HIC-Vac network is supported by the GCRF Networks in Vaccines Research & Development, which is co-funded by the Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC). This UK funded award is part of the EDCTP2 programme supported by the European Union. The work also benefited from facilities provided and maintained by the Makerere University-Uganda Virus Research Institute Centre of Excellence for Infection and Immunity Research and Training (MUII). MUII is supported through the DELTAS Africa Initiative [107743]. The DELTAS Africa Initiative is an independent funding scheme of the African Academy of Sciences (AAS), Alliance for Accelerating Excellence in Science in Africa (AESA), and supported by the New Partnership for Africa\u2019s Development Planning and Coordinating Agency (NEPAD Agency) with funding from the Wellcome Trust [107743] and the UK Government.\nAME is a fellow of the African Academy of Sciences. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}