{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T07:57:57Z","timestamp":1790927877636,"version":"4.1.0"},"reference-count":33,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:p>Mycophenolate mofetil (MMF) is an immunosuppressive drug widely used by solid organ transplant recipients. Although it is known that MMF suppresses immune responses, its exact effects on specific vaccinations have not been investigated yet. Mucosal vaccinations are increasingly used, such as a cholera vaccination consisting of two oral immunizations (oral cholera vaccination; OCV). This study aimed to investigate the specific immunosuppressive effects of MMF use during the first dose of OCV in a randomized, placebo\u2010controlled trial in healthy volunteers. Moreover, the study aimed to characterize the immune response provoked by OCV in detail. This randomized, placebo\u2010controlled, single\u2010blind trial included 16 healthy volunteers, each receiving two doses of Dukoral\u00ae and an intranasal rechallenge. Outcome measures were serum antibody responses (IgA and IgG) and IgA levels in saliva. Additionally, peripheral blood mononuclear cells (PBMCs) of participants were investigated for ex\u00a0vivo cytokine production and expression of tissue\u2010specific homing markers after OCV. There were considerable serum IgA and IgG responses after vaccination. MMF\u2010treated volunteers still showed a significant cholera antibody response, though data suggest a potential suppression by MMF without reaching statistical significance. There was no substantial IgA response in saliva. Investigation of PBMCs from OCV\u2010treated participants showed a Th2 skewing with increased ex\u00a0vivo production of TNF, IL\u20102, IL\u20105, IL\u201013, and IL\u201022 compared to the placebo group. Taken together, this study provides a framework for future clinical pharmacology studies building on OCV as a challenge model and for further investigation of specific effects of MMF on mucosal vaccination responses.<\/jats:p>","DOI":"10.1002\/cpt.70399","type":"journal-article","created":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T03:44:17Z","timestamp":1784691857000},"page":"1049-1056","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Characterization of the Immune Response after Oral Cholera Vaccination (\n                    <scp>OCV<\/scp>\n                    ) and Effects of Mycophenolate Mofetil on Priming of this Immune Response\u2014A Randomized, Placebo\u2010Controlled Trial"],"prefix":"10.1002","volume":"120","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1763-3122","authenticated-orcid":false,"given":"Boukje C.","family":"Eveleens Maarse","sequence":"first","affiliation":[{"name":"Centre for Human Drug Research  Leiden The Netherlands"},{"name":"Leiden University Medical Centre  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6927-397X","authenticated-orcid":false,"given":"Aliede E.","family":"in 't Veld","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden The Netherlands"},{"name":"Leiden University Medical Centre  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5611-108X","authenticated-orcid":false,"given":"Hendrika W.","family":"Grievink","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden The Netherlands"},{"name":"Leiden University Medical Centre  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9207-1807","authenticated-orcid":false,"given":"Manon A.A.","family":"Jansen","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthijs","family":"Moerland","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden The Netherlands"},{"name":"Leiden University Medical Centre  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,21]]},"reference":[{"key":"e_1_2_10_1_1","doi-asserted-by":"publisher","DOI":"10.1038\/nm1213"},{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.01.028"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1601775"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2025.118205"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0264-410X(96)00175-2"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/0264-410X(95)00016-T"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/tropicalmed6020064"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-014-0506-0"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2019.04.010"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2014-307127"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/ctr.13997"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/microorganisms13071579"},{"key":"e_1_2_10_13_1","doi-asserted-by":"crossref","DOI":"10.1128\/spectrum.00263-22","article-title":"Development of an effective nontoxigenic Clostridioides difficile\u2010based Oral vaccine against C. difficile infection","volume":"10","author":"Wang S.","year":"2022","journal-title":"Microbiol. 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