{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T02:38:39Z","timestamp":1794019119856,"version":"4.8.0"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2016,10,5]],"date-time":"2016-10-05T00:00:00Z","timestamp":1475625600000},"content-version":"vor","delay-in-days":643,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly attenuated smallpox vaccine modified vaccinia Ankara (MVA) in HIV-infected and healthy subjects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects. Subjects received 2 doses of MVA administered 4 weeks apart. Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories. Immune responses were assessed using enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Five hundred seventy-nine subjects were vaccinated at least once and had data available for analysis. Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects. Modified vaccinia Ankara was safe and well tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-\/pericarditis reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations.<\/jats:p><\/jats:sec>","DOI":"10.1093\/ofid\/ofv040","type":"journal-article","created":{"date-parts":[[2015,5,6]],"date-time":"2015-05-06T00:50:36Z","timestamp":1430873436000},"source":"Crossref","is-referenced-by-count":117,"title":["Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial"],"prefix":"10.1093","volume":"2","author":[{"given":"Edgar Turner","family":"Overton","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack","family":"Stapleton","sequence":"additional","affiliation":[{"name":"Dept. of Internal Medicine, Microbiology & Immunology, University of Iowa, Iowa City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Frank","sequence":"additional","affiliation":[{"name":"Dept. of Infectious Diseases Section, University of Pennsylvania, Philadelphia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn","family":"Hassler","sequence":"additional","affiliation":[{"name":"Optimus Medical Group, San Francisco, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul A","family":"Goepfert","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Barker","sequence":"additional","affiliation":[{"name":"Core Center, Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Wagner","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfred","family":"von Krempelhuber","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline GmbH & Co. KG, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garth","family":"Virgin","sequence":"additional","affiliation":[{"name":"Vifor Pharma Ltd, Glattbrugg, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josef","family":"Weigl","sequence":"additional","affiliation":[{"name":"Public Health Institute Ploen, Hamburgerstr, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas Peter","family":"Meyer","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jutta","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"B\u00e4deker","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Gr\u00fcnert","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Young","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siegfried","family":"R\u00f6sch","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Maclennan","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathaly","family":"Arndtz-Wiedemann","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Chaplin","sequence":"additional","affiliation":[{"name":"Bavarian Nordic, Martinsried"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2015,5,5]]},"reference":[{"key":"2020081006373032700_OFV040C1","doi-asserted-by":"crossref","first-page":"1263","DOI":"10.1056\/NEJM198011273032204","article-title":"The confirmation and maintenance of smallpox eradication","volume":"303","author":"Breman","year":"1980","journal-title":"N Engl J Med"},{"key":"2020081006373032700_OFV040C2","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1016\/S0147-9571(03)00025-0","article-title":"Smallpox vaccination and bioterrorism with pox viruses","volume":"26","author":"Mayr","year":"2003","journal-title":"Comp Immunol Microbiol Infect 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