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It has been suggested that its mode of action requires the host immune system, as it is difficult to reproduce its clinical efficacy in vitro. We therefore studied the effects of a single dose of ivermectin (Stromectol\n                      <jats:sup>\u00ae<\/jats:sup>\n                      \u20140.15\u00a0mg\/kg) on cytokine levels and immune cell gene expression in human volunteers. This dose reduces bloodstream microfilariae rapidly and for several months when given in mass drug administration programmes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Healthy volunteers with no travel history to endemic regions were given 3\u20134 tablets, depending on their weight, of either ivermectin or a placebo. Blood samples were drawn immediately prior to administration, 4\u00a0h and 24\u00a0h afterwards, and complete blood counts performed. Serum levels of 41 cytokines and chemokines were measured using Luminex\n                      <jats:sup>\u00ae<\/jats:sup>\n                      and expression levels of 770 myeloid-cell-related genes determined using the NanoString nCounter\n                      <jats:sup>\u00ae<\/jats:sup>\n                      . Cytokine levels at 4\u00a0h and 24\u00a0h post-treatment were compared to the levels pre-treatment using simple\n                      <jats:italic>t<\/jats:italic>\n                      tests to determine if any individual results required further investigation, taking\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009\u2009&lt;\u20090.05 as the level of significance. NanoString data were analysed on the proprietary software, nSolver\u2122.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      No significant differences were observed in complete blood counts or cytokine levels at either time point between people given ivermectin versus placebo. Only three genes showed a significant change in expression in peripheral blood mononuclear cells 4\u00a0h after ivermectin was given; there were no significant changes 24\u00a0h after drug administration or in polymorphonuclear cells at either time point. Leukocytes isolated from those participants given ivermectin showed no difference in their ability to kill\n                      <jats:italic>Brugia malayi<\/jats:italic>\n                      microfilariae in vitro.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Overall, our data do not support a direct effect of ivermectin, when given at the dose used in current filarial elimination programmes, on the human immune system.<\/jats:p>\n                    <jats:p>\n                      <jats:italic>Trial registration<\/jats:italic>\n                      ClinicalTrials.gov NCT03459794 Registered 9th March 2018, Retrospectively registered\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03459794?term=NCT03459794&amp;draw=2&amp;rank=1\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03459794?term=NCT03459794&amp;draw=2&amp;rank=1<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical Abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1186\/s13071-021-04810-6","type":"journal-article","created":{"date-parts":[[2021,6,5]],"date-time":"2021-06-05T17:02:27Z","timestamp":1622912547000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Lack of detectable short-term effects of a single dose of ivermectin on the human immune system"],"prefix":"10.1186","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct03459794","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Natalie E.","family":"Wilson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara J.","family":"Reaves","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7989-3929","authenticated-orcid":false,"given":"Adrian J.","family":"Wolstenholme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,5]]},"reference":[{"key":"4810_CR1","doi-asserted-by":"publisher","first-page":"i3","DOI":"10.1093\/inthealth\/ihx038","volume":"10","author":"KM Gustavsen","year":"2018","unstructured":"Gustavsen KM, Colatrella BD, McCoy T. 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Human subjects recruited under the guidelines of IRB-approved protocols were provided written informed consent. Human blood material was obtained from the Clinical and Translational Research Unit, University of Georgia; experiments and informed consent procedures were approved by the Institutional Review Boards of the University of Georgia (STUDY00005069).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"304"}}