Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development
Identifieur interne : 000D12 ( Pmc/Curation ); précédent : 000D11; suivant : 000D13Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development
Auteurs : Christine C. RobertsSource :
- Human Vaccines & Immunotherapeutics [ 2164-5515 ] ; 2019.
Abstract
Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.
Url:
DOI: 10.1080/21645515.2019.1634992
PubMed: 31268394
PubMed Central: 6816404
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development</title><author><name sortKey="Roberts, Christine C" sort="Roberts, Christine C" uniqKey="Roberts C" first="Christine C." last="Roberts">Christine C. Roberts</name><affiliation><nlm:aff id="AFF0001"></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">31268394</idno><idno type="pmc">6816404</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816404</idno><idno type="RBID">PMC:6816404</idno><idno type="doi">10.1080/21645515.2019.1634992</idno><date when="2019">2019</date><idno type="wicri:Area/Pmc/Corpus">000D12</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000D12</idno><idno type="wicri:Area/Pmc/Curation">000D12</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000D12</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development</title><author><name sortKey="Roberts, Christine C" sort="Roberts, Christine C" uniqKey="Roberts C" first="Christine C." last="Roberts">Christine C. Roberts</name><affiliation><nlm:aff id="AFF0001"></nlm:aff></affiliation></author></analytic><series><title level="j">Human Vaccines & Immunotherapeutics</title><idno type="ISSN">2164-5515</idno><idno type="eISSN">2164-554X</idno><imprint><date when="2019">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>ABSTRACT</title><p>Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Madore, Dv" uniqKey="Madore D">DV Madore</name></author><author><name sortKey="Meade, Bd" uniqKey="Meade B">BD Meade</name></author><author><name sortKey="Rubin, F" uniqKey="Rubin F">F Rubin</name></author><author><name sortKey="Deal, C" uniqKey="Deal C">C Deal</name></author><author><name sortKey="Lynn, F" uniqKey="Lynn F">F. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="iso-abbrev">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="publisher-id">KHVI</journal-id><journal-id journal-id-type="publisher-id">khvi20</journal-id><journal-title-group><journal-title>Human Vaccines & Immunotherapeutics</journal-title></journal-title-group><issn pub-type="ppub">2164-5515</issn><issn pub-type="epub">2164-554X</issn><publisher><publisher-name>Taylor & Francis</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">31268394</article-id><article-id pub-id-type="pmc">6816404</article-id><article-id pub-id-type="publisher-id">1634992</article-id><article-id pub-id-type="doi">10.1080/21645515.2019.1634992</article-id><article-categories><subj-group subj-group-type="heading"><subject>Review</subject></subj-group></article-categories><title-group><article-title>Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development</article-title><alt-title alt-title-type="running-authors">C. C. ROBERTS</alt-title><alt-title alt-title-type="running-title">HUMAN VACCINES & IMMUNOTHERAPEUTICS</alt-title></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0003-4359-7946</contrib-id><name><surname>Roberts</surname><given-names>Christine C.</given-names></name><xref ref-type="corresp" rid="AN0001"></xref><xref ref-type="aff" rid="AFF0001"></xref></contrib><aff id="AFF0001"><institution>Clinical Laboratory Development, GeneOne Life Science, Inc.</institution>, Blue Bell, PA,<country>USA</country></aff></contrib-group><author-notes><corresp id="AN0001">Contact Christine C. Roberts <email xlink:href="croberts@geneonels-us.com">croberts@geneonels-us.com</email><institution>Clinical Laboratory Development, GeneOne Life Science, Inc</institution>., <addr-line>1040 DeKalb Pike, Suite 200</addr-line>, Blue Bell, PA 19422, <country>USA</country>.</corresp></author-notes><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>16</day><month>7</month><year>2019</year></pub-date><pub-date pub-type="pmc-release"><day>16</day><month>7</month><year>2019</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>15</volume><issue>10</issue><fpage seq="7">2258</fpage><lpage>2263</lpage><history><date date-type="received"><day>04</day><month>4</month><year>2019</year></date><date date-type="rev-recd"><day>20</day><month>5</month><year>2019</year></date><date date-type="accepted"><day>17</day><month>6</month><year>2019</year></date></history><permissions><copyright-statement>© 2019 GeneOne Life Science, Inc. Published with license by Taylor & Francis Group, LLC.</copyright-statement><copyright-year>2019</copyright-year><copyright-holder>The Author(s)</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/">http://creativecommons.org/licenses/by-nc-nd/4.0/</ext-link>), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.</license-p></license><license><license-p>This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.</license-p></license></permissions><self-uri content-type="pdf" xlink:href="KHVI_15_1634992.pdf"></self-uri><abstract><title>ABSTRACT</title><p>Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.</p></abstract><kwd-group kwd-group-type="author"><title>KEYWORDS</title><kwd>Emerging infectious disease</kwd><kwd>vaccines</kwd><kwd>immune response</kwd><kwd>virus detection</kwd><kwd>zika virus</kwd><kwd>flaviviruses</kwd><kwd>clinical trials</kwd></kwd-group><counts><ref-count count="73"></ref-count><page-count count="6"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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