Humoral and cell-mediated immune responses to H5N1 plant-made virus-like particle vaccine are differentially impacted by alum and GLA-SE adjuvants in a Phase 2 clinical trial
Identifieur interne : 000194 ( Main/Exploration ); précédent : 000193; suivant : 000195Humoral and cell-mediated immune responses to H5N1 plant-made virus-like particle vaccine are differentially impacted by alum and GLA-SE adjuvants in a Phase 2 clinical trial
Auteurs : Stéphane Pillet ; Éric Aubin ; Sonia Trépanier ; Jean-François Poulin ; Bader Yassine-Diab ; Jan Ter Meulen [États-Unis] ; Brian J. Ward ; Nathalie LandrySource :
- NPJ Vaccines [ 2059-0105 ] ; 2018.
Abstract
The hemagglutinination inhibition (HI) response remains the gold standard used for the licensure of influenza vaccines. However, cell-mediated immunity (CMI) deserves more attention, especially when evaluating H5N1 influenza vaccines that tend to induce poor HI response. In this study, we measured the humoral response (HI) and CMI (flow cytometry) during a Phase II dose-ranging clinical trial (NCT01991561). Subjects received two intramuscular doses, 21 days apart, of plant-derived virus-like particles (VLP) presenting the A/Indonesia/05/2005 H5N1 influenza hemagglutinin protein (H5) at the surface of the VLP (H5VLP). The vaccine was co-administrated with Alhydrogel® or with a glucopyranosyl lipid adjuvant-stable emulsion (GLA-SE). We demonstrated that low doses (3.75 or 7.5 μg H5VLP) of GLA-SE-adjuvanted vaccines induced HI responses that met criteria for licensure at both antigen doses tested. Alhydrogel adjuvanted vaccines induced readily detectable HI response that however failed to meet licensure criteria at any of three doses (10, 15 and 20 μg) tested. The H5VLP also induced a sustained (up to 6 months) polyfunctional and cross-reactive HA-specific CD4+ T cell response in all vaccinated groups. Interestingly, the frequency of central memory Th1-primed precursor cells before the boost significantly correlated with HI titers 21 days after the boost. The ability of the low dose GLA-SE-adjuvanted H5VLP to elicit both humoral response and a sustained cross-reactive CMI in healthy adults is very attractive and could result in significant dose-sparing in a pandemic situation.
Url:
DOI: 10.1038/s41541-017-0043-3
PubMed: 29387473
PubMed Central: 5780465
Affiliations:
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4811</institution-id><institution-id institution-id-type="GRID">grid.63984.30</institution-id><institution>Research Institute of the McGill University Health Centre,</institution></institution-wrap>Montreal, H4A 3J1 QC Canada</nlm:aff><wicri:noCountry code="subfield">H4A 3J1 QC Canada</wicri:noCountry></affiliation></author><author><name sortKey="Aubin, Eric" sort="Aubin, Eric" uniqKey="Aubin E" first="Éric" last="Aubin">Éric Aubin</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0635 0044</institution-id><institution-id institution-id-type="GRID">grid.421219.d</institution-id><institution>Medicago Inc.,</institution></institution-wrap>Québec, G1V 3V9 QC Canada</nlm:aff><wicri:noCountry code="subfield">G1V 3V9 QC Canada</wicri:noCountry></affiliation></author><author><name sortKey="Trepanier, Sonia" sort="Trepanier, Sonia" uniqKey="Trepanier S" first="Sonia" last="Trépanier">Sonia Trépanier</name><affiliation><nlm:aff 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Canada</wicri:noCountry></affiliation></author><author><name sortKey="Ter Meulen, Jan" sort="Ter Meulen, Jan" uniqKey="Ter Meulen J" first="Jan" last="Ter Meulen">Jan Ter Meulen</name><affiliation wicri:level="2"><nlm:aff id="Aff4">Immune Design, Seattle, WA 98102 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Washington (État)</region></placeName><wicri:cityArea>Immune Design, Seattle</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:aff id="Aff5">Immune Design, San Francisco, CA 94080-7006 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Immune Design, San Francisco</wicri:cityArea></affiliation></author><author><name sortKey="Ward, Brian J" sort="Ward, Brian J" uniqKey="Ward B" first="Brian J." last="Ward">Brian J. Ward</name><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9064 4811</institution-id><institution-id institution-id-type="GRID">grid.63984.30</institution-id><institution>Research Institute of the McGill University Health Centre,</institution></institution-wrap>Montreal, H4A 3J1 QC Canada</nlm:aff><wicri:noCountry code="subfield">H4A 3J1 QC Canada</wicri:noCountry></affiliation></author><author><name sortKey="Landry, Nathalie" sort="Landry, Nathalie" uniqKey="Landry N" first="Nathalie" last="Landry">Nathalie Landry</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0635 0044</institution-id><institution-id institution-id-type="GRID">grid.421219.d</institution-id><institution>Medicago Inc.,</institution></institution-wrap>Québec, G1V 3V9 QC Canada</nlm:aff><wicri:noCountry code="subfield">G1V 3V9 QC Canada</wicri:noCountry></affiliation></author></analytic><series><title level="j">NPJ Vaccines</title><idno type="eISSN">2059-0105</idno><imprint><date when="2018">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p id="Par1">The hemagglutinination inhibition (HI) response remains the gold standard used for the licensure of influenza vaccines. However, cell-mediated immunity (CMI) deserves more attention, especially when evaluating H5N1 influenza vaccines that tend to induce poor HI response. In this study, we measured the humoral response (HI) and CMI (flow cytometry) during a Phase II dose-ranging clinical trial (NCT01991561). Subjects received two intramuscular doses, 21 days apart, of plant-derived virus-like particles (VLP) presenting the A/Indonesia/05/2005 H5N1 influenza hemagglutinin protein (H5) at the surface of the VLP (H5VLP). The vaccine was co-administrated with Alhydrogel<sup>®</sup> or with a glucopyranosyl lipid adjuvant-stable emulsion (GLA-SE). We demonstrated that low doses (3.75 or 7.5 μg H5VLP) of GLA-SE-adjuvanted vaccines induced HI responses that met criteria for licensure at both antigen doses tested. Alhydrogel adjuvanted vaccines induced readily detectable HI response that however failed to meet licensure criteria at any of three doses (10, 15 and 20 μg) tested. The H5VLP also induced a sustained (up to 6 months) polyfunctional and cross-reactive HA-specific CD4<sup>+</sup> T cell response in all vaccinated groups. Interestingly, the frequency of central memory Th1-primed precursor cells before the boost significantly correlated with HI titers 21 days after the boost. The ability of the low dose GLA-SE-adjuvanted H5VLP to elicit both humoral response and a sustained cross-reactive CMI in healthy adults is very attractive and could result in significant dose-sparing in a pandemic situation.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Yang, Y" uniqKey="Yang Y">Y Yang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Baz, M" uniqKey="Baz M">M Baz</name></author><author><name sortKey="Luke, Cj" uniqKey="Luke C">CJ Luke</name></author><author><name sortKey="Cheng, X" uniqKey="Cheng X">X Cheng</name></author><author><name sortKey="Jin, H" uniqKey="Jin H">H Jin</name></author><author><name sortKey="Subbarao, K" uniqKey="Subbarao K">K Subbarao</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="D Oust, Ma" uniqKey="D Oust M">MA D’Aoust</name></author></analytic></biblStruct><biblStruct><analytic><author><name 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Hendriks</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Borst, J" uniqKey="Borst J">J Borst</name></author><author><name sortKey="Hendriks, J" uniqKey="Hendriks J">J Hendriks</name></author><author><name sortKey="Xiao, Y" uniqKey="Xiao Y">Y Xiao</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lin, J" uniqKey="Lin J">J Lin</name></author><author><name sortKey="Somanathan, S" uniqKey="Somanathan S">S Somanathan</name></author><author><name sortKey="Roy, S" uniqKey="Roy S">S Roy</name></author><author><name sortKey="Calcedo, R" uniqKey="Calcedo R">R Calcedo</name></author><author><name sortKey="Wilson, Jm" uniqKey="Wilson J">JM Wilson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lucas, M" uniqKey="Lucas M">M Lucas</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tortorella, C" uniqKey="Tortorella C">C Tortorella</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Teijaro, Jr" uniqKey="Teijaro J">JR Teijaro</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wilkinson, Tm" uniqKey="Wilkinson T">TM Wilkinson</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li><li>Washington (État)</li></region></list><tree><noCountry><name sortKey="Aubin, Eric" sort="Aubin, Eric" uniqKey="Aubin E" first="Éric" last="Aubin">Éric Aubin</name><name sortKey="Landry, Nathalie" sort="Landry, Nathalie" uniqKey="Landry N" first="Nathalie" last="Landry">Nathalie Landry</name><name sortKey="Pillet, Stephane" sort="Pillet, Stephane" uniqKey="Pillet S" first="Stéphane" last="Pillet">Stéphane Pillet</name><name sortKey="Poulin, Jean Francois" sort="Poulin, Jean Francois" uniqKey="Poulin J" first="Jean-François" last="Poulin">Jean-François Poulin</name><name sortKey="Trepanier, Sonia" sort="Trepanier, Sonia" uniqKey="Trepanier S" first="Sonia" last="Trépanier">Sonia Trépanier</name><name sortKey="Ward, Brian J" sort="Ward, Brian J" uniqKey="Ward B" first="Brian J." last="Ward">Brian J. Ward</name><name sortKey="Yassine Diab, Bader" sort="Yassine Diab, Bader" uniqKey="Yassine Diab B" first="Bader" last="Yassine-Diab">Bader Yassine-Diab</name></noCountry><country name="États-Unis"><region name="Washington (État)"><name sortKey="Ter Meulen, Jan" sort="Ter Meulen, Jan" uniqKey="Ter Meulen J" first="Jan" last="Ter Meulen">Jan Ter Meulen</name></region><name sortKey="Ter Meulen, Jan" sort="Ter Meulen, Jan" uniqKey="Ter Meulen J" first="Jan" last="Ter Meulen">Jan Ter Meulen</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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