Enhancing the reproducibility of serological methods used to evaluate immunogenicity of pandemic H1N1 influenza vaccines-an effective EU regulatory approach.
Identifieur interne : 000C90 ( PubMed/Checkpoint ); précédent : 000C89; suivant : 000C91Enhancing the reproducibility of serological methods used to evaluate immunogenicity of pandemic H1N1 influenza vaccines-an effective EU regulatory approach.
Auteurs : Ralf Wagner [Allemagne] ; Constanze Göpfert ; Joanna Hammann ; Britta Neumann ; John Wood ; Robert Newman ; Chantal Wallis ; Nina Alex ; Michael PfleidererSource :
- Vaccine [ 1873-2518 ] ; 2012.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Anticorps neutralisants (sang), Dosage immunologique (normes), Enfant, Enfant d'âge préscolaire, Femelle, Grippe humaine (), Humains, Jeune adulte, Mâle, Normes de référence, Nourrisson, Nouveau-né, Reproductibilité des résultats, Sous-type H1N1 du virus de la grippe A (immunologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Techniques de laboratoire clinique (normes), Union européenne, Vaccination (normes), Vaccins antigrippaux (immunologie), Vaccins antigrippaux (normes).
- MESH :
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux.
- normes : Dosage immunologique, Techniques de laboratoire clinique, Vaccination, Vaccins antigrippaux.
- sang : Anticorps antiviraux, Anticorps neutralisants.
- Adolescent, Adulte, Adulte d'âge moyen, Enfant, Enfant d'âge préscolaire, Femelle, Grippe humaine, Humains, Jeune adulte, Mâle, Normes de référence, Nourrisson, Nouveau-né, Reproductibilité des résultats, Sujet âgé, Sujet âgé de 80 ans ou plus, Union européenne.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Neutralizing (blood), Antibodies, Viral (blood), Child, Child, Preschool, Clinical Laboratory Techniques (standards), European Union, Female, Humans, Immunoassay (standards), Infant, Infant, Newborn, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (immunology), Influenza Vaccines (standards), Influenza, Human (prevention & control), Male, Middle Aged, Reference Standards, Reproducibility of Results, Vaccination (standards), Young Adult.
- MESH :
- chemical , blood : Antibodies, Neutralizing, Antibodies, Viral.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza Vaccines.
- prevention & control : Influenza, Human.
- standards : Clinical Laboratory Techniques, Immunoassay, Influenza Vaccines, Vaccination.
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, European Union, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Reference Standards, Reproducibility of Results, Young Adult.
Abstract
Haemagglutination-inhibition (HI) and virus neutralisation (VN) assays are routinely applied to evaluate influenza vaccine immunogenicity for regulatory approval. Despite their frequent use both assays are currently only poorly standardised causing considerable inter-laboratory variation of serological results that is particularly evident for pandemic influenza vaccines. The present study was conducted in association with the European Medicines Agency (EMA) to directly compare assay variability between vaccine manufacturer's and European regulatory agency's laboratories in an influenza pandemic scenario. To this end, a defined subset of H1N1 pdm clinical trial sera from all manufacturers that had applied at EMA for approval of pandemic H1N1 vaccines were re-tested by the National Institute for Biological Standards and Control (for HI) and the Paul Ehrlich Institute (for VN). Comparative analysis of test results determined for almost 2000 serum samples revealed a marked inter-laboratory variation for HI titres (up to 5.8-fold) and even more for neutralisation titres (up to 7.0-fold). When the absolute titres were adjusted relative to the calibrated International Antibody Standard 09/194 variation was drastically reduced and acceptable agreement of results from different laboratories could be achieved. Hence, inclusion of an appropriate calibrated antibody standard for adjustment of original titres is a powerful tool to substantially increase reproducibility of serological results from different laboratories and to significantly improve regulatory evaluation of influenza vaccine efficacy.
DOI: 10.1016/j.vaccine.2012.02.077
PubMed: 22446639
Affiliations:
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Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Enfant</term><term>Enfant d'âge préscolaire</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Normes de référence</term><term>Nourrisson</term><term>Nouveau-né</term><term>Reproductibilité des résultats</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Union européenne</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Haemagglutination-inhibition (HI) and virus neutralisation (VN) assays are routinely applied to evaluate influenza vaccine immunogenicity for regulatory approval. Despite their frequent use both assays are currently only poorly standardised causing considerable inter-laboratory variation of serological results that is particularly evident for pandemic influenza vaccines. The present study was conducted in association with the European Medicines Agency (EMA) to directly compare assay variability between vaccine manufacturer's and European regulatory agency's laboratories in an influenza pandemic scenario. To this end, a defined subset of H1N1 pdm clinical trial sera from all manufacturers that had applied at EMA for approval of pandemic H1N1 vaccines were re-tested by the National Institute for Biological Standards and Control (for HI) and the Paul Ehrlich Institute (for VN). Comparative analysis of test results determined for almost 2000 serum samples revealed a marked inter-laboratory variation for HI titres (up to 5.8-fold) and even more for neutralisation titres (up to 7.0-fold). When the absolute titres were adjusted relative to the calibrated International Antibody Standard 09/194 variation was drastically reduced and acceptable agreement of results from different laboratories could be achieved. Hence, inclusion of an appropriate calibrated antibody standard for adjustment of original titres is a powerful tool to substantially increase reproducibility of serological results from different laboratories and to significantly improve regulatory evaluation of influenza vaccine efficacy.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22446639</PMID><DateCompleted><Year>2012</Year><Month>09</Month><Day>20</Day></DateCompleted><DateRevised><Year>2019</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>30</Volume><Issue>27</Issue><PubDate><Year>2012</Year><Month>Jun</Month><Day>08</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Enhancing the reproducibility of serological methods used to evaluate immunogenicity of pandemic H1N1 influenza vaccines-an effective EU regulatory approach.</ArticleTitle><Pagination><MedlinePgn>4113-22</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2012.02.077</ELocationID><Abstract><AbstractText>Haemagglutination-inhibition (HI) and virus neutralisation (VN) assays are routinely applied to evaluate influenza vaccine immunogenicity for regulatory approval. Despite their frequent use both assays are currently only poorly standardised causing considerable inter-laboratory variation of serological results that is particularly evident for pandemic influenza vaccines. The present study was conducted in association with the European Medicines Agency (EMA) to directly compare assay variability between vaccine manufacturer's and European regulatory agency's laboratories in an influenza pandemic scenario. To this end, a defined subset of H1N1 pdm clinical trial sera from all manufacturers that had applied at EMA for approval of pandemic H1N1 vaccines were re-tested by the National Institute for Biological Standards and Control (for HI) and the Paul Ehrlich Institute (for VN). Comparative analysis of test results determined for almost 2000 serum samples revealed a marked inter-laboratory variation for HI titres (up to 5.8-fold) and even more for neutralisation titres (up to 7.0-fold). When the absolute titres were adjusted relative to the calibrated International Antibody Standard 09/194 variation was drastically reduced and acceptable agreement of results from different laboratories could be achieved. Hence, inclusion of an appropriate calibrated antibody standard for adjustment of original titres is a powerful tool to substantially increase reproducibility of serological results from different laboratories and to significantly improve regulatory evaluation of influenza vaccine efficacy.</AbstractText><CopyrightInformation>Copyright © 2012 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wagner</LastName><ForeName>Ralf</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Paul-Ehrlich-Institut, 63225 Langen, Paul-Ehrlich-Straße 51-59, Germany. Ralf.Wagner@pei.de</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Göpfert</LastName><ForeName>Constanze</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Hammann</LastName><ForeName>Joanna</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Neumann</LastName><ForeName>Britta</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Wood</LastName><ForeName>John</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Newman</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Wallis</LastName><ForeName>Chantal</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Alex</LastName><ForeName>Nina</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Pfleiderer</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D023362">Evaluation Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>03</Month><Day>22</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="D057134">Antibodies, Neutralizing</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D057134" MajorTopicYN="N">Antibodies, Neutralizing</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019411" MajorTopicYN="N">Clinical Laboratory Techniques</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005062" MajorTopicYN="N">European Union</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007118" MajorTopicYN="N">Immunoassay</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007231" MajorTopicYN="N">Infant, Newborn</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012015" MajorTopicYN="N">Reference Standards</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2011</Year><Month>08</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2012</Year><Month>02</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2012</Year><Month>02</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>3</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2012</Year><Month>3</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2012</Year><Month>9</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">22446639</ArticleId><ArticleId IdType="pii">S0264-410X(12)00330-1</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2012.02.077</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li></country></list><tree><noCountry><name sortKey="Alex, Nina" sort="Alex, Nina" uniqKey="Alex N" first="Nina" last="Alex">Nina Alex</name><name sortKey="Gopfert, Constanze" sort="Gopfert, Constanze" uniqKey="Gopfert C" first="Constanze" last="Göpfert">Constanze Göpfert</name><name sortKey="Hammann, Joanna" sort="Hammann, Joanna" uniqKey="Hammann J" first="Joanna" last="Hammann">Joanna Hammann</name><name sortKey="Neumann, Britta" sort="Neumann, Britta" uniqKey="Neumann B" first="Britta" last="Neumann">Britta Neumann</name><name sortKey="Newman, Robert" sort="Newman, Robert" uniqKey="Newman R" first="Robert" last="Newman">Robert Newman</name><name sortKey="Pfleiderer, Michael" sort="Pfleiderer, Michael" uniqKey="Pfleiderer M" first="Michael" last="Pfleiderer">Michael Pfleiderer</name><name sortKey="Wallis, Chantal" sort="Wallis, Chantal" uniqKey="Wallis C" first="Chantal" last="Wallis">Chantal Wallis</name><name sortKey="Wood, John" sort="Wood, John" uniqKey="Wood J" first="John" last="Wood">John Wood</name></noCountry><country name="Allemagne"><noRegion><name sortKey="Wagner, Ralf" sort="Wagner, Ralf" uniqKey="Wagner R" first="Ralf" last="Wagner">Ralf Wagner</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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