{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,2]],"date-time":"2023-10-02T07:15:43Z","timestamp":1696230943736},"reference-count":22,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,1,29]],"date-time":"2016-01-29T00:00:00Z","timestamp":1454025600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Biomedical Advanced Research and Development Authority, Department of Health and Human Services"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Influenza Resp Viruses"],"published-print":{"date-parts":[[2016,3]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>The potency of inactivated influenza vaccines is determined using a single\u2010radial immunodiffusion (SRID) assay and requires standardized reagents consisting of a Reference Antigen and an influenza strain\u2010specific antiserum. Timely availability of reagents is a critical step in influenza vaccine production, and the need for backup approaches for reagent preparation is an important component of pandemic preparedness.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>When novel H7N9 viruses emerged in China in 2013, candidate inactivated H7N9 influenza vaccines were developed for evaluation in clinical trials, and reagents were needed to measure vaccine potency.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We previously described an alternative approach for generating strain\u2010specific potency antisera, utilizing modified vaccinia virus Ankara vectors to produce influenza hemagglutinin (<jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content>)\u2010containing virus\u2010like particles (<jats:styled-content style=\"fixed-case\">VLP<\/jats:styled-content>s) for immunization. Vector\u2010produced <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> antigen is not dependent upon the success of the traditional bromelain\u2010digestion and <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> purification.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Antiserum for H7N9 vaccines, produced after immunization of sheep with preparations of bromelain\u2010<jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> (br\u2010<jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content>), was not optimal for the <jats:styled-content style=\"fixed-case\">SRID<\/jats:styled-content> assay, and the supply of antiserum was limited. However, antiserum obtained from sheep boosted with <jats:styled-content style=\"fixed-case\">VLP<\/jats:styled-content>s containing H7 <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> greatly improved the ring quality in the <jats:styled-content style=\"fixed-case\">SRID<\/jats:styled-content> assay. Importantly, this antiserum worked well with both egg\u2010 and cell\u2010derived antigen and was distributed to vaccine manufacturers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Utilizing a previously developed approach for preparing vaccine potency antiserum, we have addressed a major bottleneck encountered in preparation of H7N9 vaccine reagents. The combination of br\u2010<jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> and mammalian <jats:styled-content style=\"fixed-case\">VLP<\/jats:styled-content>s for sequential immunization represents the first use of an alternative approach for producing an influenza vaccine potency antiserum.<\/jats:p><\/jats:sec>","DOI":"10.1111\/irv.12365","type":"journal-article","created":{"date-parts":[[2015,11,30]],"date-time":"2015-11-30T04:28:41Z","timestamp":1448857721000},"page":"134-140","source":"Crossref","is-referenced-by-count":5,"title":["A novel approach for preparation of the antisera reagent for potency determination of inactivated H7N9 influenza vaccines"],"prefix":"10.1111","volume":"10","author":[{"given":"Falko","family":"Schmeisser","sequence":"first","affiliation":[{"name":"Laboratory of DNA Viruses Division of Viral Products Center for Biologics Evaluations and Research, Food and Drug Administration Silver Spring MD 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