{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T07:28:43Z","timestamp":1789802923116,"version":"4.0.1"},"update-to":[{"DOI":"10.12688\/aasopenres.12841.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2018,8,6]],"date-time":"2018-08-06T00:00:00Z","timestamp":1533513600000}}],"reference-count":35,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2018,8,6]],"date-time":"2018-08-06T00:00:00Z","timestamp":1533513600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000278","name":"Department for International Development, UK Government","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000278","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100011858","name":"African Academy of Sciences","doi-asserted-by":"crossref","award":["107743"],"award-info":[{"award-number":["107743"]}],"id":[{"id":"10.13039\/501100011858","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Wellcome Trust","award":["209337, 107743"],"award-info":[{"award-number":["209337, 107743"]}]},{"DOI":"10.13039\/501100009250","name":"New Partnership for Africa's Development","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100009250","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["aasopenresearch.org"],"crossmark-restriction":false},"short-container-title":["AAS Open Res"],"abstract":"<ns4:p>\n                    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\n                    <ns4:italic>Schistosoma mansoni<\/ns4:italic>\n                    (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-na\u00efve 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.\u00a0 To explore the possibility of establishing the CHI-S in Uganda, a Stakeholders\u2019 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.\n                  <\/ns4:p>","DOI":"10.12688\/aasopenres.12841.2","type":"journal-article","created":{"date-parts":[[2018,8,6]],"date-time":"2018-08-06T05:40:08Z","timestamp":1533534008000},"page":"2","update-policy":"https:\/\/doi.org\/10.12688\/aasopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":37,"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."],"prefix":"10.12688","volume":"1","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2818-9549","authenticated-orcid":false,"given":"Alison 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Badanga","family":"Nazziwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asuman","family":"Muwumuza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Yazdanbakhsh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pontiano","family":"Kaleebu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Narcis","family":"Kabatereine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edridah","family":"Tukahebwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2560","published-online":{"date-parts":[[2018,8,6]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"405-18","DOI":"10.1016\/j.jinf.2014.01.006","article-title":"Advancing the 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Murphy, Department of Laboratory Medicine, University of Washington, Seattle, WA, USA, 02 May 2018, version 1, indexed","URL":"https:\/\/aasopenresearch.org\/articles\/1-2\/v1#referee-response-26337","order":0,"name":"referee-response-26337","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Alison Elliott<\/b>; <i>Posted: 25 Jul 2018<\/i>; <b><i>Major issues:<\/i><\/b> <i>While the&nbsp;paper provides an excellent overview of schistosomiasis and the CHI-S model, the transition from background on schistosomiasis to the report on the meeting&nbsp;could benefit from a brief foreshadowing of the major findings from the stakeholders meeting.&nbsp; While the technical hurdles to implementation of the CHI-S model in Uganda were more easily identified and labeled (and are present in Table 3), it seems more difficult to identify discrete core ethical and community based hurdles.&nbsp;&nbsp;The authors could consider adding more bullet points to Table 3 to expand on some of these ethical and community based hurdles.&nbsp; The authors could also add a few overview-type sentences when the paper transitions from Background\/Summary to Stakeholder meeting report.<\/i> We have added the requested bullet points to Table 3 to expand on the ethical and community based hurdles. In addition, we have added an introductory paragraph where the paper transitions from describing the background to the findings in the stakeholders meeting, to ensure that the switch is clear to the readers. <b><i>Minor issues:<\/i><\/b> <i>The section titled \u201cThe controlled human schistosome infection model\u201d could be re-titled \u201cThe controlled human schistosome infection model and considerations for adaptation to Ugandan site\u201d.<\/i> We agree with the reviewer suggestion to make clear that we will specifically address the Ugandan site. However, taking into account also the major issue raised by this reviewer that the transition of the manuscript from introduction to the findings of the meeting was unclear, we have decided to do this by adding a section title \u201c <b>Considerations on implementation of the novel CHI-S model in the endemic setting in Uganda<\/b>\u201d to mark the transition of the paper and simultaneously indicate the specific relevance to Uganda. <i>Is there any possibility that adoption of new strains could carry unexpected bacterial flora that could cause unexpected AEs?<\/i> Infected snails are tested for their bioburden before cercaria are used for CHI-S purpose. Potentially new strains could carry a different bioburden which would preclude their use in CHI-S, but this needs to be tested. To highlight the fact that bioburden testing would need to take place for new strains we have added this in our section on technical considerations. <i>The scientific rationale for importation of the Leiden CHI-S snails\/parasites as compared to use of locally-acquired snails\/parasites could be expanded upon more fully.<\/i> We have expanded the requested paragraph. <i>The following sentence is much too long and should be split into 2-3 sentences to improve readability: \u201cPopulations of interest for CHI-S will include Ugandans not previously exposed to schistosomiasis (perhaps from an urban setting) as well as those from schistosomiasis-endemic communities (prior exposure for inclusion or exclusion can be determined by measuring IgG antibody to schistosome egg antigen): experience in Kenya with the controlled human malaria infection (CHMI) model showed that participants coming from areas with no active transmission (Nairobi residents) had low baseline responses to malaria, and a challenge response similar to Europeans3, whereas those resident where active malaria transmission occurs had higher baseline responses - indicative of either recent or prior malaria exposure - and a distinct profile of response to challenge (Kapulu, Bejon personal communication).&quot;<\/i> We have split the sentence. <i>Note that Sanaria's PfSPZ product is NOT yet &quot;FDA approved&quot;.&nbsp; This misunderstanding should be corrected toward the end of the section titled \u201cEthical and regulatory considerations for CHI-S in Uganda\u201d.&nbsp; The Sanaria product is being investigated under an FDA Investigational New Drug application.<\/i> This mistake has been corrected. <i>The section \u201cContribution from representatives of endemic communities\u201d lists contributions from a single individual who is said to speak for some of these communities.&nbsp; However, the section title sounds more generalized than the text indicates.&nbsp; I would suggest folding this section into another section as the current representation seems to potentially overly generalize the responses from one (albeit generous and collaborative) individual.<\/i> We have displaced this paragraph so that it falls under the section on \u201crecruitment considerations\u201d","URL":"https:\/\/aasopenresearch.org\/articles\/1-2\/v2#referee-comment-3081","order":1,"name":"referee-comment-3081","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/aasopenres.13967.r26567, Matthew B. Laurens, Division of Malaria Research, Institute for Global Health, University of Maryland School of Medicine, Baltimore, MD, USA, 10 Aug 2018, version 2, indexed","URL":"https:\/\/aasopenresearch.org\/articles\/1-2\/v2#referee-response-26567","order":2,"name":"referee-response-26567","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"The Uganda Stakeholders\u2019 Meeting and visits for Ugandan ethicists, regulators, and clinicians were funded by a discretionary award from the Wellcome Trust [209337]. Organisation of the meeting was also supported by the staff of the Makerere University\/Uganda Virus Research Institute Centre of Excellence for Infection and Immunity Research and Training (MUII-plus). MUII-plus 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's Development Planning and Coordinating Agency (NEPAD Agency) with funding from the Wellcome Trust [107743] and the UK Government.","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"}]}}