Conformationally selective biophysical assay for influenza vaccine potency determination.
Identifieur interne : 000401 ( PubMed/Corpus ); précédent : 000400; suivant : 000402Conformationally selective biophysical assay for influenza vaccine potency determination.
Auteurs : Yingxia Wen ; Liqun Han ; Giuseppe Palladino ; Annette Ferrari ; Yuhong Xie ; Andrea Carfi ; Philip R. Dormitzer ; Ethan C. SettembreSource :
- Vaccine [ 1873-2518 ] ; 2015.
English descriptors
- KwdEn :
- Chromatography, High Pressure Liquid, Chromatography, Reverse-Phase, Hemagglutinin Glycoproteins, Influenza Virus (immunology), Humans, Hydrogen-Ion Concentration, Immunodiffusion (methods), Influenza A virus (classification), Influenza A virus (immunology), Influenza Vaccines (immunology), Temperature, Vaccine Potency.
- MESH :
- chemical , immunology : Hemagglutinin Glycoproteins, Influenza Virus, Influenza Vaccines.
- classification : Influenza A virus.
- immunology : Influenza A virus.
- methods : Immunodiffusion.
- Chromatography, High Pressure Liquid, Chromatography, Reverse-Phase, Humans, Hydrogen-Ion Concentration, Temperature, Vaccine Potency.
Abstract
Influenza vaccines are the primary intervention for reducing the substantial health burden from pandemic and seasonal influenza. Hemagglutinin (HA) is the most important influenza vaccine antigen. Subunit and split influenza vaccines are formulated, released for clinical use, and tested for stability based on an in vitro potency assay, single-radial immunodiffusion (SRID), which selectively detects HA that is immunologically active (capable of eliciting neutralizing or hemagglutination inhibiting antibodies in an immunized subject). The time consuming generation of strain-specific sheep antisera and calibrated antigen standards for SRID can delay vaccine release. The limitation in generating SRID reagents was evident during the early days of the 2009 pandemic, prompting efforts to develop more practical, alternative, quantitative assays for immunologically active HA. Here we demonstrate that, under native conditions, trypsin selectively digests HA produced from egg or mammalian cell in monovalent vaccines that is altered by stress conditions such as reduced pH, elevated temperature, or deamidation, leaving native, pre-fusion HA, intact. Subsequent reverse-phase high pressure liquid chromatography (RP-HPLC) can separate trypsin-resistant HA from the digested HA. Integration of the resulting RP-HPLC peak yields HA quantities that match well the values obtained by SRID. Therefore, trypsin digestion, to pre-select immunologically active HA, followed by quantification by RP-HPLC is a promising alternative in vitro potency assay for influenza vaccines.
DOI: 10.1016/j.vaccine.2015.08.077
PubMed: 26348403
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pubmed:26348403Le document en format XML
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Dormitzer</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Settembre, Ethan C" sort="Settembre, Ethan C" uniqKey="Settembre E" first="Ethan C" last="Settembre">Ethan C. Settembre</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA. Electronic address: ethan.settembre@novartis.com.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26348403</idno><idno type="pmid">26348403</idno><idno type="doi">10.1016/j.vaccine.2015.08.077</idno><idno type="wicri:Area/PubMed/Corpus">000401</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000401</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Conformationally selective biophysical assay for influenza vaccine potency determination.</title><author><name sortKey="Wen, Yingxia" sort="Wen, Yingxia" uniqKey="Wen Y" first="Yingxia" last="Wen">Yingxia Wen</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Han, Liqun" sort="Han, Liqun" uniqKey="Han L" first="Liqun" last="Han">Liqun Han</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Palladino, Giuseppe" sort="Palladino, Giuseppe" uniqKey="Palladino G" first="Giuseppe" last="Palladino">Giuseppe Palladino</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ferrari, Annette" sort="Ferrari, Annette" uniqKey="Ferrari A" first="Annette" last="Ferrari">Annette Ferrari</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Xie, Yuhong" sort="Xie, Yuhong" uniqKey="Xie Y" first="Yuhong" last="Xie">Yuhong Xie</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Carfi, Andrea" sort="Carfi, Andrea" uniqKey="Carfi A" first="Andrea" last="Carfi">Andrea Carfi</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dormitzer, Philip R" sort="Dormitzer, Philip R" uniqKey="Dormitzer P" first="Philip R" last="Dormitzer">Philip R. Dormitzer</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Settembre, Ethan C" sort="Settembre, Ethan C" uniqKey="Settembre E" first="Ethan C" last="Settembre">Ethan C. Settembre</name><affiliation><nlm:affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA. Electronic address: ethan.settembre@novartis.com.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Chromatography, High Pressure Liquid</term><term>Chromatography, Reverse-Phase</term><term>Hemagglutinin Glycoproteins, Influenza Virus (immunology)</term><term>Humans</term><term>Hydrogen-Ion Concentration</term><term>Immunodiffusion (methods)</term><term>Influenza A virus (classification)</term><term>Influenza A virus (immunology)</term><term>Influenza Vaccines (immunology)</term><term>Temperature</term><term>Vaccine Potency</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Hemagglutinin Glycoproteins, Influenza Virus</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Influenza A virus</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A virus</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Immunodiffusion</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Chromatography, High Pressure Liquid</term><term>Chromatography, Reverse-Phase</term><term>Humans</term><term>Hydrogen-Ion Concentration</term><term>Temperature</term><term>Vaccine Potency</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Influenza vaccines are the primary intervention for reducing the substantial health burden from pandemic and seasonal influenza. Hemagglutinin (HA) is the most important influenza vaccine antigen. Subunit and split influenza vaccines are formulated, released for clinical use, and tested for stability based on an in vitro potency assay, single-radial immunodiffusion (SRID), which selectively detects HA that is immunologically active (capable of eliciting neutralizing or hemagglutination inhibiting antibodies in an immunized subject). The time consuming generation of strain-specific sheep antisera and calibrated antigen standards for SRID can delay vaccine release. The limitation in generating SRID reagents was evident during the early days of the 2009 pandemic, prompting efforts to develop more practical, alternative, quantitative assays for immunologically active HA. Here we demonstrate that, under native conditions, trypsin selectively digests HA produced from egg or mammalian cell in monovalent vaccines that is altered by stress conditions such as reduced pH, elevated temperature, or deamidation, leaving native, pre-fusion HA, intact. Subsequent reverse-phase high pressure liquid chromatography (RP-HPLC) can separate trypsin-resistant HA from the digested HA. Integration of the resulting RP-HPLC peak yields HA quantities that match well the values obtained by SRID. Therefore, trypsin digestion, to pre-select immunologically active HA, followed by quantification by RP-HPLC is a promising alternative in vitro potency assay for influenza vaccines. </div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26348403</PMID><DateCompleted><Year>2016</Year><Month>06</Month><Day>17</Day></DateCompleted><DateRevised><Year>2018</Year><Month>04</Month><Day>25</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>33</Volume><Issue>41</Issue><PubDate><Year>2015</Year><Month>Oct</Month><Day>05</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Conformationally selective biophysical assay for influenza vaccine potency determination.</ArticleTitle><Pagination><MedlinePgn>5342-5349</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(15)01230-X</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2015.08.077</ELocationID><Abstract><AbstractText>Influenza vaccines are the primary intervention for reducing the substantial health burden from pandemic and seasonal influenza. Hemagglutinin (HA) is the most important influenza vaccine antigen. Subunit and split influenza vaccines are formulated, released for clinical use, and tested for stability based on an in vitro potency assay, single-radial immunodiffusion (SRID), which selectively detects HA that is immunologically active (capable of eliciting neutralizing or hemagglutination inhibiting antibodies in an immunized subject). The time consuming generation of strain-specific sheep antisera and calibrated antigen standards for SRID can delay vaccine release. The limitation in generating SRID reagents was evident during the early days of the 2009 pandemic, prompting efforts to develop more practical, alternative, quantitative assays for immunologically active HA. Here we demonstrate that, under native conditions, trypsin selectively digests HA produced from egg or mammalian cell in monovalent vaccines that is altered by stress conditions such as reduced pH, elevated temperature, or deamidation, leaving native, pre-fusion HA, intact. Subsequent reverse-phase high pressure liquid chromatography (RP-HPLC) can separate trypsin-resistant HA from the digested HA. Integration of the resulting RP-HPLC peak yields HA quantities that match well the values obtained by SRID. Therefore, trypsin digestion, to pre-select immunologically active HA, followed by quantification by RP-HPLC is a promising alternative in vitro potency assay for influenza vaccines. </AbstractText><CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wen</LastName><ForeName>Yingxia</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Han</LastName><ForeName>Liqun</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Palladino</LastName><ForeName>Giuseppe</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferrari</LastName><ForeName>Annette</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xie</LastName><ForeName>Yuhong</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carfi</LastName><ForeName>Andrea</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dormitzer</LastName><ForeName>Philip R</ForeName><Initials>PR</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Settembre</LastName><ForeName>Ethan C</ForeName><Initials>EC</Initials><AffiliationInfo><Affiliation>NVS Influenza Vaccines, Now owned and operated by the CSL Group, 45 Sidney Street, Cambridge, MA 02139, USA. Electronic address: ethan.settembre@novartis.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D013487">Research Support, U.S. Gov't, P.H.S.</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>09</Month><Day>06</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019267">Hemagglutinin Glycoproteins, Influenza Virus</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D002851" MajorTopicYN="Y">Chromatography, High Pressure Liquid</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D056148" MajorTopicYN="Y">Chromatography, Reverse-Phase</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019267" MajorTopicYN="N">Hemagglutinin Glycoproteins, Influenza Virus</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006863" MajorTopicYN="N">Hydrogen-Ion Concentration</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005779" MajorTopicYN="N">Immunodiffusion</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009980" MajorTopicYN="N">Influenza A virus</DescriptorName><QualifierName UI="Q000145" MajorTopicYN="N">classification</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013696" MajorTopicYN="N">Temperature</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064166" MajorTopicYN="Y">Vaccine Potency</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Hemagglutinin</Keyword><Keyword MajorTopicYN="N">Influenza</Keyword><Keyword MajorTopicYN="N">Potency</Keyword><Keyword MajorTopicYN="N">Reversed-phase high pressure liquid chromatography</Keyword><Keyword MajorTopicYN="N">Trypsinization</Keyword><Keyword MajorTopicYN="N">Vaccine</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>05</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>08</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>08</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>9</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>9</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>6</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26348403</ArticleId><ArticleId IdType="pii">S0264-410X(15)01230-X</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2015.08.077</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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