{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T04:17:40Z","timestamp":1793506660013,"version":"4.5.0"},"reference-count":33,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2025,3,16]],"date-time":"2025-03-16T00:00:00Z","timestamp":1742083200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Ministry of Health Brazilian Government","award":["TED 224-2017"],"award-info":[{"award-number":["TED 224-2017"]}],"id":[{"id":"https:\/\/ror.org\/02y7p0749","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Ministry of Health Brazilian Government","award":["IOC-008-FIO22-2-33"],"award-info":[{"award-number":["IOC-008-FIO22-2-33"]}],"id":[{"id":"https:\/\/ror.org\/02y7p0749","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Orygen Biotecnologia S A","award":["TED 224-2017"],"award-info":[{"award-number":["TED 224-2017"]}]},{"name":"Orygen Biotecnologia S A","award":["IOC-008-FIO22-2-33"],"award-info":[{"award-number":["IOC-008-FIO22-2-33"]}]},{"DOI":"10.13039\/501100006507","name":"Oswaldo Cruz Institute\/Fiocruz","doi-asserted-by":"publisher","award":["TED 224-2017"],"award-info":[{"award-number":["TED 224-2017"]}],"id":[{"id":"10.13039\/501100006507","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100006507","name":"Oswaldo Cruz Institute\/Fiocruz","doi-asserted-by":"publisher","award":["IOC-008-FIO22-2-33"],"award-info":[{"award-number":["IOC-008-FIO22-2-33"]}],"id":[{"id":"10.13039\/501100006507","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: Following previous successful Phase I clinical trials conducted in men and women in a non-endemic area for schistosomiasis in Brazil, the Sm14 vaccine was evaluated in an endemic region in Senegal. We report successful clinical trials in adults (Phase IIa) and school children (Phase IIb), respectively, of a Schistosoma mansoni 14 kDa fatty acid-binding protein (Sm14) vaccine + a glucopyranosyl lipid A (GLA-SE) adjuvant. Methods: Participants were evaluated based on clinical assessments, laboratory tests (including hematologic and biochemical analyses of renal and hepatic functions), and immunological parameters (humoral and cellular responses) up to 12 months after the first vaccination dose in the Phase IIa trial and after 120 days in the Phase IIb trial. Results: The results showed strong immunogenic responses and good tolerance in both adults and children, with no major adverse effects. Importantly, significant increases in Sm14-specific total IgG (IgG1 and IgG3) were observed as early as 30 days after the first vaccination, with high titres remaining at least 120 days afterwards. Sm14-specific total IgG serum levels were also significantly enhanced in adults and in both infected and non-infected, vaccinated children and elicited robust cytokine responses with increased TNF\u03b1, IFN-\u03b3, and IL-2 profiles. Conclusions: Overall, the Sm14+GLA-SE vaccine is safe and highly immunogenic, with a clearly protective potential against schistosomiasis, supporting progression to the next Phase III clinical trials.<\/jats:p>","DOI":"10.3390\/vaccines13030316","type":"journal-article","created":{"date-parts":[[2025,3,17]],"date-time":"2025-03-17T07:49:57Z","timestamp":1742197797000},"page":"316","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["The Sm14+GLA-SE Recombinant Vaccine Against Schistosoma mansoni and S. haematobium in Adults and School Children: Phase II Clinical Trials in West Africa"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-6917-7805","authenticated-orcid":false,"given":"Amadou Tidjani","family":"Ly","sequence":"first","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doudou","family":"Diop","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Modou","family":"Diop","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Marie","family":"Schacht","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"},{"name":"CIIL-Center for Infection and Immunity of Lille, Institut Pasteur de Lille, University of Lille, CNRS UMR, Inserm U1019-Lille, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdoulaye","family":"Mbengue","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rokhaya","family":"Diagne","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marieme","family":"Guisse","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Pierre","family":"Dompnier","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina","family":"Messias","sequence":"additional","affiliation":[{"name":"Laboratory on Thymus Research, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"},{"name":"Brazilian National Institute of Science and Technology on Neuroimmunomodulation, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6974-5666","authenticated-orcid":false,"given":"Rhea N.","family":"Coler","sequence":"additional","affiliation":[{"name":"Seattle Children\u2019s Research Institute, Center for Global Infectious Disease Research, Seattle, WA 98105, USA"},{"name":"Department of Pediatrics, University of Washington School of Medicine, Seattle, WA 98105, USA"},{"name":"Department of Global Health, University of Washington, Seattle, WA 98105, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5760-8661","authenticated-orcid":false,"given":"Celso R.","family":"Ramos","sequence":"additional","affiliation":[{"name":"Fenix Biotec Treinamento SS LTDA, S\u00e3o Paulo 05591-090, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9662-5333","authenticated-orcid":false,"given":"Jacques-No\u00ebl","family":"Tendeng","sequence":"additional","affiliation":[{"name":"Hopital R\u00e9gional de Saint Louis, UFR 2S, Universit\u00e9 Gaston Berger, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seynabou","family":"Ndiaye","sequence":"additional","affiliation":[{"name":"R\u00e9gion M\u00e9dicale de Saint Louis, Minist\u00e8re de la Sant\u00e9 et de l\u2019Action Sociale, Saint Louis BP 226, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miryam","family":"Marroquin-Quelopana","sequence":"additional","affiliation":[{"name":"Fenix Biotec Treinamento SS LTDA, S\u00e3o Paulo 05591-090, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ju\u00e7ara","family":"de Carvalho Parra","sequence":"additional","affiliation":[{"name":"Laboratory of Anti-Helminth Vaccine Research and Development, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21045-900, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiane","family":"dos Santos","sequence":"additional","affiliation":[{"name":"Laboratory of Anti-Helminth Vaccine Research and Development, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21045-900, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5431-4086","authenticated-orcid":false,"given":"Mar\u00edlia","family":"Sirianni dos Santos Almeida","sequence":"additional","affiliation":[{"name":"Laboratory of Anti-Helminth Vaccine Research and Development, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21045-900, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3697-1506","authenticated-orcid":false,"given":"Daniella Ar\u00eaas","family":"Mendes-da-Cruz","sequence":"additional","affiliation":[{"name":"Laboratory on Thymus Research, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"},{"name":"Brazilian National Institute of Science and Technology on Neuroimmunomodulation, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"},{"name":"Rio de Janeiro Research Network on Neuroinflammation, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"},{"name":"INOVA-IOC Network on Neuroimmunomodulation, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Reed","sequence":"additional","affiliation":[{"name":"HDT BioCorp, Seattle, WA 98102, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilson","family":"Savino","sequence":"additional","affiliation":[{"name":"Laboratory on Thymus Research, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"},{"name":"Brazilian National Institute of Science and Technology on Neuroimmunomodulation, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"},{"name":"Rio de Janeiro Research Network on Neuroinflammation, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"},{"name":"INOVA-IOC Network on Neuroimmunomodulation, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21040-360, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Riveau","sequence":"additional","affiliation":[{"name":"Biomedical Research Center Espoir Pour La Sant\u00e9, Saint Louis BP 226, Senegal"},{"name":"CIIL-Center for Infection and Immunity of Lille, Institut Pasteur de Lille, University of Lille, CNRS UMR, Inserm U1019-Lille, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9471-7461","authenticated-orcid":false,"given":"Miriam","family":"Tendler","sequence":"additional","affiliation":[{"name":"Laboratory of Anti-Helminth Vaccine Research and Development, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 21045-900, Brazil"},{"name":"FABP Biotech, Rio de Janeiro 22611-100, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,3,16]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2022). 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