VaxArray potency assay for rapid assessment of "pandemic" influenza vaccines.
Identifieur interne : 000215 ( PubMed/Curation ); précédent : 000214; suivant : 000216VaxArray potency assay for rapid assessment of "pandemic" influenza vaccines.
Auteurs : Rose T. Byrne-Nash [États-Unis] ; David F. Miller [États-Unis] ; Katie M. Bueter [États-Unis] ; Jacob H. Gillis [États-Unis] ; Laura R. Kuck [États-Unis] ; Kathy L. Rowlen [États-Unis]Source :
- NPJ vaccines [ 2059-0105 ] ; 2018.
Abstract
The VaxArray Influenza Pandemic HA (VXI-pHA) potency assay is a multiplexed sandwich immunoassay that consists of nine broadly reactive yet subtype-specific monoclonal capture antibodies printed in microarray format and a suite of fluor-labeled secondary antibodies that were selected to probe conserved HA epitopes. VXI-pHA was designed to optimize the probability that the ready-to-use assay would work for the most concerning, emergent influenza A strains, eliminating the need for the time-consuming process of reference reagents production. The performance of this new potency test was evaluated using a panel of 48 potentially pandemic strains of influenza viruses and vaccines spanning 16 years of antigenic drift, including the most recent pre-pandemic vaccine being developed against the "5th wave" A/H7N9 virus. The VXI-pHA assay demonstrated coverage of 93%, 92%, and 100% for H5, H7, and H9 antigens, respectively. The assay demonstrated high sensitivity with linear dynamic ranges of more than 150-fold and quantification limits ranging from 1 to 5 ng/mL. For three production lots of H7N9 monobulk drug substance, the assay exhibited excellent accuracy (100 ± 6%) and analytical precision (CV 6 ± 2%). The high assay sensitivity enabled robust detection and quantification of hemagglutinin in crude in-process samples and low-dose, adjuvanted vaccines with an accuracy of 100 ± 10%.
DOI: 10.1038/s41541-018-0080-6
PubMed: 30323954
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Byrne-Nash</name><affiliation wicri:level="2"><nlm:affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Colorado</region></placeName><wicri:cityArea>InDevR Inc., 2100 Central Ave., Suite 106, Boulder</wicri:cityArea></affiliation></author><author><name sortKey="Miller, David F" sort="Miller, David F" uniqKey="Miller D" first="David F" last="Miller">David F. Miller</name><affiliation wicri:level="2"><nlm:affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Colorado</region></placeName><wicri:cityArea>InDevR Inc., 2100 Central Ave., Suite 106, Boulder</wicri:cityArea></affiliation></author><author><name sortKey="Bueter, Katie M" sort="Bueter, Katie M" uniqKey="Bueter K" first="Katie M" last="Bueter">Katie M. 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Kuck</name><affiliation wicri:level="2"><nlm:affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Colorado</region></placeName><wicri:cityArea>InDevR Inc., 2100 Central Ave., Suite 106, Boulder</wicri:cityArea></affiliation></author><author><name sortKey="Rowlen, Kathy L" sort="Rowlen, Kathy L" uniqKey="Rowlen K" first="Kathy L" last="Rowlen">Kathy L. Rowlen</name><affiliation wicri:level="2"><nlm:affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Colorado</region></placeName><wicri:cityArea>InDevR Inc., 2100 Central Ave., Suite 106, Boulder</wicri:cityArea></affiliation></author></analytic><series><title level="j">NPJ vaccines</title><idno type="eISSN">2059-0105</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The VaxArray Influenza Pandemic HA (VXI-pHA) potency assay is a multiplexed sandwich immunoassay that consists of nine broadly reactive yet subtype-specific monoclonal capture antibodies printed in microarray format and a suite of fluor-labeled secondary antibodies that were selected to probe conserved HA epitopes. VXI-pHA was designed to optimize the probability that the ready-to-use assay would work for the most concerning, emergent influenza A strains, eliminating the need for the time-consuming process of reference reagents production. The performance of this new potency test was evaluated using a panel of 48 potentially pandemic strains of influenza viruses and vaccines spanning 16 years of antigenic drift, including the most recent pre-pandemic vaccine being developed against the "5<sup>th</sup> wave" A/H7N9 virus. The VXI-pHA assay demonstrated coverage of 93%, 92%, and 100% for H5, H7, and H9 antigens, respectively. The assay demonstrated high sensitivity with linear dynamic ranges of more than 150-fold and quantification limits ranging from 1 to 5 ng/mL. For three production lots of H7N9 monobulk drug substance, the assay exhibited excellent accuracy (100 ± 6%) and analytical precision (CV 6 ± 2%). The high assay sensitivity enabled robust detection and quantification of hemagglutinin in crude in-process samples and low-dose, adjuvanted vaccines with an accuracy of 100 ± 10%.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">30323954</PMID><DateRevised><Year>2019</Year><Month>11</Month><Day>20</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">2059-0105</ISSN><JournalIssue CitedMedium="Internet"><Volume>3</Volume><PubDate><Year>2018</Year></PubDate></JournalIssue><Title>NPJ vaccines</Title><ISOAbbreviation>NPJ Vaccines</ISOAbbreviation></Journal><ArticleTitle>VaxArray potency assay for rapid assessment of "pandemic" influenza vaccines.</ArticleTitle><Pagination><MedlinePgn>43</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1038/s41541-018-0080-6</ELocationID><Abstract><AbstractText>The VaxArray Influenza Pandemic HA (VXI-pHA) potency assay is a multiplexed sandwich immunoassay that consists of nine broadly reactive yet subtype-specific monoclonal capture antibodies printed in microarray format and a suite of fluor-labeled secondary antibodies that were selected to probe conserved HA epitopes. VXI-pHA was designed to optimize the probability that the ready-to-use assay would work for the most concerning, emergent influenza A strains, eliminating the need for the time-consuming process of reference reagents production. The performance of this new potency test was evaluated using a panel of 48 potentially pandemic strains of influenza viruses and vaccines spanning 16 years of antigenic drift, including the most recent pre-pandemic vaccine being developed against the "5<sup>th</sup> wave" A/H7N9 virus. The VXI-pHA assay demonstrated coverage of 93%, 92%, and 100% for H5, H7, and H9 antigens, respectively. The assay demonstrated high sensitivity with linear dynamic ranges of more than 150-fold and quantification limits ranging from 1 to 5 ng/mL. For three production lots of H7N9 monobulk drug substance, the assay exhibited excellent accuracy (100 ± 6%) and analytical precision (CV 6 ± 2%). The high assay sensitivity enabled robust detection and quantification of hemagglutinin in crude in-process samples and low-dose, adjuvanted vaccines with an accuracy of 100 ± 10%.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Byrne-Nash</LastName><ForeName>Rose T</ForeName><Initials>RT</Initials><Identifier Source="ORCID">0000-0002-9706-5585</Identifier><AffiliationInfo><Affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</Affiliation><Identifier Source="GRID">grid.420960.9</Identifier></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Miller</LastName><ForeName>David F</ForeName><Initials>DF</Initials><AffiliationInfo><Affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</Affiliation><Identifier Source="GRID">grid.420960.9</Identifier></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bueter</LastName><ForeName>Katie M</ForeName><Initials>KM</Initials><AffiliationInfo><Affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</Affiliation><Identifier Source="GRID">grid.420960.9</Identifier></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gillis</LastName><ForeName>Jacob H</ForeName><Initials>JH</Initials><AffiliationInfo><Affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</Affiliation><Identifier Source="GRID">grid.420960.9</Identifier></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kuck</LastName><ForeName>Laura R</ForeName><Initials>LR</Initials><AffiliationInfo><Affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</Affiliation><Identifier Source="GRID">grid.420960.9</Identifier></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rowlen</LastName><ForeName>Kathy L</ForeName><Initials>KL</Initials><AffiliationInfo><Affiliation>InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301 USA.</Affiliation><Identifier Source="GRID">grid.420960.9</Identifier></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>R44 AI102318</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2018</Year><Month>10</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>NPJ Vaccines</MedlineTA><NlmUniqueID>101699863</NlmUniqueID><ISSNLinking>2059-0105</ISSNLinking></MedlineJournalInfo><CoiStatement>K.L.R. and L.R.K. are InDevR Inc. stockholders. The remaining authors are employed by InDevR Inc. but declare no competing interests.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year><Month>02</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2018</Year><Month>08</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2018</Year><Month>08</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2018</Year><Month>10</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2018</Year><Month>10</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2018</Year><Month>10</Month><Day>17</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">30323954</ArticleId><ArticleId IdType="doi">10.1038/s41541-018-0080-6</ArticleId><ArticleId IdType="pii">80</ArticleId><ArticleId IdType="pmc">PMC6175820</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Rev Med Virol. 2012 Jul;22(4):267-79</Citation><ArticleIdList><ArticleId IdType="pubmed">22438243</ArticleId></ArticleIdList></Reference><Reference><Citation>J Virol. 1968 Apr;2(4):281-8</Citation><ArticleIdList><ArticleId IdType="pubmed">4911843</ArticleId></ArticleIdList></Reference><Reference><Citation>Biologicals. 2010 Mar;38(2):284-9</Citation><ArticleIdList><ArticleId IdType="pubmed">20074976</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccines (Basel). 2015 Feb 05;3(1):90-104</Citation><ArticleIdList><ArticleId IdType="pubmed">26344948</ArticleId></ArticleIdList></Reference><Reference><Citation>MBio. 2016 Apr 19;7(2):e00417-16</Citation><ArticleIdList><ArticleId IdType="pubmed">27094330</ArticleId></ArticleIdList></Reference><Reference><Citation>Immunochemistry. 1965 Sep;2(3):235-54</Citation><ArticleIdList><ArticleId IdType="pubmed">4956917</ArticleId></ArticleIdList></Reference><Reference><Citation>J Infect Dis. 1976 Oct;134(4):384-94</Citation><ArticleIdList><ArticleId IdType="pubmed">789791</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet Infect Dis. 2015 Mar;15(3):340-7</Citation><ArticleIdList><ArticleId IdType="pubmed">25661473</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2017 Apr 4;35(15):1918-1925</Citation><ArticleIdList><ArticleId IdType="pubmed">28262335</ArticleId></ArticleIdList></Reference><Reference><Citation>Virol J. 2013 May 04;10:141</Citation><ArticleIdList><ArticleId IdType="pubmed">23642219</ArticleId></ArticleIdList></Reference><Reference><Citation>Nat Protoc. 2010 Jan;5(1):14-9</Citation><ArticleIdList><ArticleId IdType="pubmed">20010723</ArticleId></ArticleIdList></Reference><Reference><Citation>Influenza Other Respir Viruses. 2012 May;6(3):176-87</Citation><ArticleIdList><ArticleId IdType="pubmed">21902817</ArticleId></ArticleIdList></Reference><Reference><Citation>PLoS One. 2014 Oct 20;9(10):e109616</Citation><ArticleIdList><ArticleId IdType="pubmed">25330238</ArticleId></ArticleIdList></Reference><Reference><Citation>Influenza Other Respir Viruses. 2013 Nov;7(6):961-8</Citation><ArticleIdList><ArticleId IdType="pubmed">23496824</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2010 Mar 11;28(12):2442-9</Citation><ArticleIdList><ArticleId IdType="pubmed">20074687</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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