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Varicella zoster immune globulin (human) (VARIZIG) is recommended for post-exposure prophylaxis to prevent or attenuate varicella infection in high-risk individuals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An open-label, expanded-access program provided VARIZIG to high-risk individuals exposed to varicella or herpes zoster. Immunocompromised participants were stratified by type of immunocompromising condition (\u201concologic immunodeficiency\u201d, \u201cprimary immunodeficiency\u201d, \u201csolid organ transplant\u201d [SOT], \u201chematopoietic cell transplant\u201d [HCT], and \u201cother\u201d). Patient characteristics, type of exposure and varicella outcome, and safety data were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This analysis included 40 adults (primary [<jats:italic>n<\/jats:italic>\u2009=\u20096] or oncologic [<jats:italic>n<\/jats:italic>\u2009=\u200910] immunodeficiencies, history of SOT [<jats:italic>n<\/jats:italic>\u2009=\u20095] or HCT [<jats:italic>n<\/jats:italic>\u2009=\u20096], and other [<jats:italic>n<\/jats:italic>\u2009=\u200913]), and 263 children (primary [<jats:italic>n<\/jats:italic>\u2009=\u200913] or oncologic [<jats:italic>n<\/jats:italic>\u2009=\u2009152] immunodeficiencies, history of SOT [<jats:italic>n<\/jats:italic>\u2009=\u200936] or HCT [<jats:italic>n<\/jats:italic>\u2009=\u200917], and other [<jats:italic>n<\/jats:italic>\u2009=\u200945]). Among adults and children, 48% vs 72% were exposed to varicella, 38% vs 16% were exposed to herpes zoster, and 15% vs 12% had an unspecified exposure. Overall incidence of varicella infection in adults after VARIZIG use was 6%; incidence of varicella infection in children after VARIZIG use was 7%. Similar rates were noted in each subgroup. Most cases of varicella were mild, with two children developing &gt;\u2009100 lesions and no cases of varicella-related pneumonia or encephalitis. Varicella-related hospitalizations occurred primarily in children with oncologic immunodeficiencies. One serious adverse event (serum sickness) was considered related to VARIZIG and occurred in a child with oncologic immunodeficiency. There were no varicella- or VARIZIG-related deaths.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These data indicate that VARIZIG may reduce severity of varicella in immunocompromised children and adults.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>This study was retrospectively registered with the public clinical trial identification<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00338442?term=NCT00338442&amp;draw=2amp;rank=1\">NCT00338442<\/jats:ext-link>at<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>on 20 June 2006.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12879-020-05656-6","type":"journal-article","created":{"date-parts":[[2021,1,11]],"date-time":"2021-01-11T08:03:11Z","timestamp":1610352191000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9190-263X","authenticated-orcid":false,"given":"Hayley","family":"Gans","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0277-3088","authenticated-orcid":false,"given":"Roy F.","family":"Chemaly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,1,11]]},"reference":[{"issue":"3","key":"5656_CR1","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1007\/s00277-013-1951-6","volume":"93","author":"C Konig","year":"2014","unstructured":"Konig C, Kleber M, Reinhardt H, Knop S, Wasch R, Engelhardt M. 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The protocol and amendments, the informed consent form, and study-related materials were reviewed and approved by a central independent ethics committee (Western Institutional Review Board, Puyallup, WA, USA) before study initiation and throughout the conduct of the study. All patients (or their guardians) provided written informed consent.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"HG has received funding\/grant support from National Vaccine Program Office, National Institutes of Health, and honorarium for consultancy from US Department of Health and Human Services. RFC has received funding\/grant support paid to his institution from Merck, Chimerix, Viracor, Oxford Immunotec, Xenex, Gilead, Ansun Pharmaceuticals, Shire\/Takeda, and AiCuris, and honorarium for consultancy from Xenex, Merck, Chimerix, Shire\/Takeda, Ansun Pharmaceuticals, Pulmotec, Clinigen, Oxford Immunotec, ReViral, Kyorin, Genentech, and Janssen.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"46"}}