{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T07:37:52Z","timestamp":1768808272052,"version":"3.49.0"},"reference-count":0,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"6","license":[{"start":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T00:00:00Z","timestamp":1638316800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,1]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n<jats:p>Zika virus (ZIKV) is transmitted primarily through infected <jats:italic>Aedes aegypti<\/jats:italic> or <jats:italic>Aedes albopictus<\/jats:italic> mosquitoes. ZIKV infection during pregnancy was linked to adverse fetal\/infant outcomes, including microcephaly, brain anomalies, ocular disorders, intrauterine growth restriction, and other congenital malformations. Human anti-Zika virus immunoglobulin (ZIKV-Ig) is being developed for prophylaxis of ZIKV in at-risk populations, including women of childbearing potential and pregnant women. A phase 1 single-center, double-blind, randomized, placebo-controlled study was conducted to assess the safety and pharmacokinetics (PK) of a single 50.0-mL ZIKV-Ig intravenous dose in healthy adult male or non-pregnant female subjects 18 to 55 years of age. Subjects received either ZIKV-Ig (<jats:italic>n<\/jats:italic>\u2009=\u200919) or saline placebo (<jats:italic>n<\/jats:italic>\u2009=\u200911). Safety was evaluated based on adverse events (AEs), laboratory test results, physical examinations, and vital signs. Overall, there were 11 subjects (36.7%) with treatment-related AEs including eight subjects (42.1%) in the ZIKV-Ig group and three subjects (27.3%) in the placebo group. Of the AEs considered treatment related, three subjects (15.8%) experienced headache (mild). There were no serious AEs, no deaths, and no discontinuations resulting from AEs. Overall, the safety profile of ZIKV-Ig in this study population of healthy adult subjects appeared to be safe and well tolerated. The results of the pharmacokinetic analysis determined that ZIKV-Ig had a maximum observed concentration of 182.3\u2009U\/mL (coefficient of variation, 21.3%), the time at which C<jats:sub>max<\/jats:sub> occurred of 2.3 hours\u2009\u00b1\u20091.0 (SD), an area under the concentration\u2013time curve<jats:sub>0\u2013\u221e<\/jats:sub> of 77,224 h\u2009\u00d7\u2009U\/mL (coefficient of variation, 17.9%), and a half-life of 28.1 days, which is similar to other human-derived commercial Ig intravenous products.<\/jats:p>","DOI":"10.4269\/ajtmh.20-1578","type":"journal-article","created":{"date-parts":[[2021,10,11]],"date-time":"2021-10-11T15:35:02Z","timestamp":1633966502000},"page":"1552-1562","source":"Crossref","is-referenced-by-count":12,"title":["Results of a Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Anti-Zika Virus Immunoglobulin"],"prefix":"10.4269","volume":"105","author":[{"given":"Jane","family":"White","sequence":"first","affiliation":[{"name":"1Emergent BioSolutions Inc., Gaithersburg, Maryland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Priya","family":"Tunga","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah M.","family":"Anderson","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ken","family":"Iledan","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tobi","family":"Loreth","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geraldine S.","family":"Parrera","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hugo","family":"Astacio","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bojan","family":"Drobic","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason S.","family":"Richardson","sequence":"additional","affiliation":[{"name":"2Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","container-title":["The American Journal of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/105\/6\/article-p1552.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/105\/6\/article-p1552.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T23:02:33Z","timestamp":1638399753000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/105\/6\/article-p1552.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,12,1]]},"references-count":0,"journal-issue":{"issue":"6"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.20-1578","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,12,1]]}}}