Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant
Identifieur interne : 001B68 ( Ncbi/Merge ); précédent : 001B67; suivant : 001B69Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant
Auteurs : David L. Gordon [Australie] ; Dimitar Sajkov [Australie] ; Yoshikazu Honda-Okubo [Australie] ; Samuel H. Wilks [Royaume-Uni] ; Malet Aban [Australie] ; Ian G. Barr [Australie] ; Nikolai Petrovsky [Australie]Source :
- Vaccine [ 0264-410X ] ; 2016.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Femelle, Grippe humaine (), Humains, Inuline (administration et posologie), Inuline (analogues et dérivés), Mâle, Méthode en simple aveugle, Sous-type H3N2 du virus de la grippe A, Tests d'inhibition de l'hémagglutination, Vaccins antigrippaux (usage thérapeutique), Vaccins inactivés (usage thérapeutique).
- MESH :
- administration et posologie : Adjuvants immunologiques, Inuline.
- analogues et dérivés : Inuline.
- sang : Anticorps antiviraux.
- usage thérapeutique : Vaccins antigrippaux, Vaccins inactivés.
- Adulte, Adulte d'âge moyen, Femelle, Grippe humaine, Humains, Mâle, Méthode en simple aveugle, Sous-type H3N2 du virus de la grippe A, Tests d'inhibition de l'hémagglutination.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adult, Antibodies, Viral (blood), Female, Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H3N2 Subtype, Influenza Vaccines (therapeutic use), Influenza, Human (prevention & control), Inulin (administration & dosage), Inulin (analogs & derivatives), Male, Middle Aged, Single-Blind Method, Vaccines, Inactivated (therapeutic use).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Inulin.
- chemical , analogs & derivatives : Inulin.
- chemical , blood : Antibodies, Viral.
- chemical , therapeutic use : Influenza Vaccines, Vaccines, Inactivated.
- prevention & control : Influenza, Human.
- Adult, Female, Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H3N2 Subtype, Male, Middle Aged, Single-Blind Method.
Abstract
First-in-man study of seasonal influenza vaccine containing Advax delta inulin-based adjuvant. Advax adjuvant was safe and well tolerated. Advax adjuvant enabled up to 10-fold antigen dose-sparing. First use of antibody landscapes to compare adjuvanted and unadjuvanted vaccine groups.
Url:
DOI: 10.1016/j.vaccine.2016.05.071
PubMed: 27342914
PubMed Central: 4949042
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PMC:4949042Le document en format XML
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Gordon</name><affiliation wicri:level="1"><nlm:aff id="af005">Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Sajkov, Dimitar" sort="Sajkov, Dimitar" uniqKey="Sajkov D" first="Dimitar" last="Sajkov">Dimitar Sajkov</name><affiliation wicri:level="1"><nlm:aff id="af010">Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Honda Okubo, Yoshikazu" sort="Honda Okubo, Yoshikazu" uniqKey="Honda Okubo Y" first="Yoshikazu" last="Honda-Okubo">Yoshikazu Honda-Okubo</name><affiliation wicri:level="1"><nlm:aff id="af015">Department of Endocrinology, Flinders University, 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042</wicri:regionArea><wicri:noRegion>5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af020">Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author><author><name sortKey="Wilks, Samuel H" sort="Wilks, Samuel H" uniqKey="Wilks S" first="Samuel H." last="Wilks">Samuel H. Wilks</name><affiliation wicri:level="4"><nlm:aff id="af025">Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ</wicri:regionArea><orgName type="university">Université de Cambridge</orgName><placeName><settlement type="city">Cambridge</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Angleterre de l'Est</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="af030">World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ</wicri:regionArea><wicri:noRegion>Cambridge CB2 3EJ</wicri:noRegion></affiliation></author><author><name sortKey="Aban, Malet" sort="Aban, Malet" uniqKey="Aban M" first="Malet" last="Aban">Malet Aban</name><affiliation wicri:level="1"><nlm:aff id="af035">WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Barr, Ian G" sort="Barr, Ian G" uniqKey="Barr I" first="Ian G." last="Barr">Ian G. Barr</name><affiliation wicri:level="1"><nlm:aff id="af035">WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="af040">Department of Microbiology & Immunology, University of Melbourne, Victoria 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology & Immunology, University of Melbourne, Victoria 3000</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Petrovsky, Nikolai" sort="Petrovsky, Nikolai" uniqKey="Petrovsky N" first="Nikolai" last="Petrovsky">Nikolai Petrovsky</name><affiliation wicri:level="1"><nlm:aff id="af010">Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af015">Department of Endocrinology, Flinders University, 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042</wicri:regionArea><wicri:noRegion>5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af020">Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="ISSN">0264-410X</idno><idno type="eISSN">1873-2518</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Adult</term><term>Antibodies, Viral (blood)</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Influenza A Virus, H3N2 Subtype</term><term>Influenza Vaccines (therapeutic use)</term><term>Influenza, Human (prevention & control)</term><term>Inulin (administration & dosage)</term><term>Inulin (analogs & derivatives)</term><term>Male</term><term>Middle Aged</term><term>Single-Blind Method</term><term>Vaccines, Inactivated (therapeutic use)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adjuvants immunologiques (administration et posologie)</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps antiviraux (sang)</term><term>Femelle</term><term>Grippe humaine ()</term><term>Humains</term><term>Inuline (administration et posologie)</term><term>Inuline (analogues et dérivés)</term><term>Mâle</term><term>Méthode en simple aveugle</term><term>Sous-type H3N2 du virus de la grippe A</term><term>Tests d'inhibition de l'hémagglutination</term><term>Vaccins antigrippaux (usage thérapeutique)</term><term>Vaccins inactivés (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Inulin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Inulin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Adjuvants immunologiques</term><term>Inuline</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Inuline</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Influenza A Virus, H3N2 Subtype</term><term>Male</term><term>Middle Aged</term><term>Single-Blind Method</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Mâle</term><term>Méthode en simple aveugle</term><term>Sous-type H3N2 du virus de la grippe A</term><term>Tests d'inhibition de l'hémagglutination</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Highlights</title><p><list list-type="simple" id="l0005"><list-item id="o0005"><label>•</label><p id="p0005">First-in-man study of seasonal influenza vaccine containing Advax delta inulin-based adjuvant.</p></list-item><list-item id="o0010"><label>•</label><p id="p0010">Advax adjuvant was safe and well tolerated.</p></list-item><list-item id="o0015"><label>•</label><p id="p0015">Advax adjuvant enabled up to 10-fold antigen dose-sparing.</p></list-item><list-item id="o0020"><label>•</label><p id="p0020">First use of antibody landscapes to compare adjuvanted and unadjuvanted vaccine groups.</p></list-item></list></p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Fleming, D M" uniqKey="Fleming D">D.M. Fleming</name></author><author><name sortKey="Elliot, A J" uniqKey="Elliot A">A.J. Elliot</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cooper, P D" uniqKey="Cooper P">P.D. Cooper</name></author><author><name sortKey="Petrovsky, N" uniqKey="Petrovsky N">N. Petrovsky</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cooper, P D" uniqKey="Cooper P">P.D. Cooper</name></author><author><name sortKey="Barclay, T G" uniqKey="Barclay T">T.G. Barclay</name></author><author><name sortKey="Ginic Markovic, M" uniqKey="Ginic Markovic M">M. Ginic-Markovic</name></author><author><name sortKey="Petrovsky, N" uniqKey="Petrovsky N">N. Petrovsky</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cooper, P D" uniqKey="Cooper P">P.D. Cooper</name></author><author><name sortKey="Barclay, T G" uniqKey="Barclay T">T.G. 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Gordon</name><affiliation wicri:level="1"><nlm:aff id="af005">Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Sajkov, Dimitar" sort="Sajkov, Dimitar" uniqKey="Sajkov D" first="Dimitar" last="Sajkov">Dimitar Sajkov</name><affiliation wicri:level="1"><nlm:aff id="af010">Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Honda Okubo, Yoshikazu" sort="Honda Okubo, Yoshikazu" uniqKey="Honda Okubo Y" first="Yoshikazu" last="Honda-Okubo">Yoshikazu Honda-Okubo</name><affiliation wicri:level="1"><nlm:aff id="af015">Department of Endocrinology, Flinders University, 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042</wicri:regionArea><wicri:noRegion>5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af020">Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author><author><name sortKey="Wilks, Samuel H" sort="Wilks, Samuel H" uniqKey="Wilks S" first="Samuel H." last="Wilks">Samuel H. Wilks</name><affiliation wicri:level="4"><nlm:aff id="af025">Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ</wicri:regionArea><orgName type="university">Université de Cambridge</orgName><placeName><settlement type="city">Cambridge</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Angleterre de l'Est</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="af030">World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ</wicri:regionArea><wicri:noRegion>Cambridge CB2 3EJ</wicri:noRegion></affiliation></author><author><name sortKey="Aban, Malet" sort="Aban, Malet" uniqKey="Aban M" first="Malet" last="Aban">Malet Aban</name><affiliation wicri:level="1"><nlm:aff id="af035">WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Barr, Ian G" sort="Barr, Ian G" uniqKey="Barr I" first="Ian G." last="Barr">Ian G. Barr</name><affiliation wicri:level="1"><nlm:aff id="af035">WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="af040">Department of Microbiology & Immunology, University of Melbourne, Victoria 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology & Immunology, University of Melbourne, Victoria 3000</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Petrovsky, Nikolai" sort="Petrovsky, Nikolai" uniqKey="Petrovsky N" first="Nikolai" last="Petrovsky">Nikolai Petrovsky</name><affiliation wicri:level="1"><nlm:aff id="af010">Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af015">Department of Endocrinology, Flinders University, 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042</wicri:regionArea><wicri:noRegion>5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af020">Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27342914</idno><idno type="pmc">4949042</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4949042</idno><idno type="RBID">PMC:4949042</idno><idno type="doi">10.1016/j.vaccine.2016.05.071</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000E32</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000E32</idno><idno type="wicri:Area/Pmc/Curation">000E32</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000E32</idno><idno type="wicri:Area/Pmc/Checkpoint">000302</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000302</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant</title><author><name sortKey="Gordon, David L" sort="Gordon, David L" uniqKey="Gordon D" first="David L." last="Gordon">David L. Gordon</name><affiliation wicri:level="1"><nlm:aff id="af005">Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Sajkov, Dimitar" sort="Sajkov, Dimitar" uniqKey="Sajkov D" first="Dimitar" last="Sajkov">Dimitar Sajkov</name><affiliation wicri:level="1"><nlm:aff id="af010">Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Honda Okubo, Yoshikazu" sort="Honda Okubo, Yoshikazu" uniqKey="Honda Okubo Y" first="Yoshikazu" last="Honda-Okubo">Yoshikazu Honda-Okubo</name><affiliation wicri:level="1"><nlm:aff id="af015">Department of Endocrinology, Flinders University, 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042</wicri:regionArea><wicri:noRegion>5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af020">Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author><author><name sortKey="Wilks, Samuel H" sort="Wilks, Samuel H" uniqKey="Wilks S" first="Samuel H." last="Wilks">Samuel H. Wilks</name><affiliation wicri:level="4"><nlm:aff id="af025">Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ</wicri:regionArea><orgName type="university">Université de Cambridge</orgName><placeName><settlement type="city">Cambridge</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Angleterre de l'Est</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="af030">World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ</wicri:regionArea><wicri:noRegion>Cambridge CB2 3EJ</wicri:noRegion></affiliation></author><author><name sortKey="Aban, Malet" sort="Aban, Malet" uniqKey="Aban M" first="Malet" last="Aban">Malet Aban</name><affiliation wicri:level="1"><nlm:aff id="af035">WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Barr, Ian G" sort="Barr, Ian G" uniqKey="Barr I" first="Ian G." last="Barr">Ian G. Barr</name><affiliation wicri:level="1"><nlm:aff id="af035">WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="af040">Department of Microbiology & Immunology, University of Melbourne, Victoria 3000, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology & Immunology, University of Melbourne, Victoria 3000</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Petrovsky, Nikolai" sort="Petrovsky, Nikolai" uniqKey="Petrovsky N" first="Nikolai" last="Petrovsky">Nikolai Petrovsky</name><affiliation wicri:level="1"><nlm:aff id="af010">Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af015">Department of Endocrinology, Flinders University, 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042</wicri:regionArea><wicri:noRegion>5042</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="af020">Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="ISSN">0264-410X</idno><idno type="eISSN">1873-2518</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Highlights</title><p><list list-type="simple" id="l0005"><list-item id="o0005"><label>•</label><p id="p0005">First-in-man study of seasonal influenza vaccine containing Advax delta inulin-based adjuvant.</p></list-item><list-item id="o0010"><label>•</label><p id="p0010">Advax adjuvant was safe and well tolerated.</p></list-item><list-item id="o0015"><label>•</label><p id="p0015">Advax adjuvant enabled up to 10-fold antigen dose-sparing.</p></list-item><list-item id="o0020"><label>•</label><p id="p0020">First use of antibody landscapes to compare adjuvanted and unadjuvanted vaccine groups.</p></list-item></list></p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Fleming, D M" uniqKey="Fleming D">D.M. 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Gordon</name><affiliation wicri:level="1"><nlm:affiliation>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Sajkov, Dimitar" sort="Sajkov, Dimitar" uniqKey="Sajkov D" first="Dimitar" last="Sajkov">Dimitar Sajkov</name><affiliation wicri:level="1"><nlm:affiliation>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Honda Okubo, Yoshikazu" sort="Honda Okubo, Yoshikazu" uniqKey="Honda Okubo Y" first="Yoshikazu" last="Honda-Okubo">Yoshikazu Honda-Okubo</name><affiliation wicri:level="1"><nlm:affiliation>Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author><author><name sortKey="Wilks, Samuel H" sort="Wilks, Samuel H" uniqKey="Wilks S" first="Samuel H" last="Wilks">Samuel H. Wilks</name><affiliation wicri:level="4"><nlm:affiliation>Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK; World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK; World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ</wicri:regionArea><orgName type="university">Université de Cambridge</orgName><placeName><settlement type="city">Cambridge</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Angleterre de l'Est</region></placeName></affiliation></author><author><name sortKey="Aban, Malet" sort="Aban, Malet" uniqKey="Aban M" first="Malet" last="Aban">Malet Aban</name><affiliation wicri:level="1"><nlm:affiliation>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Barr, Ian G" sort="Barr, Ian G" uniqKey="Barr I" first="Ian G" last="Barr">Ian G. Barr</name><affiliation wicri:level="4"><nlm:affiliation>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia; Department of Microbiology & Immunology, University of Melbourne, Victoria 3000, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia; Department of Microbiology & Immunology, University of Melbourne, Victoria 3000</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Petrovsky, Nikolai" sort="Petrovsky, Nikolai" uniqKey="Petrovsky N" first="Nikolai" last="Petrovsky">Nikolai Petrovsky</name><affiliation wicri:level="1"><nlm:affiliation>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia; Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia. Electronic address: nikolai.petrovsky@flinders.edu.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia; Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27342914</idno><idno type="pmid">27342914</idno><idno type="doi">10.1016/j.vaccine.2016.05.071</idno><idno type="wicri:Area/PubMed/Corpus">000521</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000521</idno><idno type="wicri:Area/PubMed/Curation">000521</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000521</idno><idno type="wicri:Area/PubMed/Checkpoint">000506</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000506</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant.</title><author><name sortKey="Gordon, David L" sort="Gordon, David L" uniqKey="Gordon D" first="David L" last="Gordon">David L. Gordon</name><affiliation wicri:level="1"><nlm:affiliation>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Sajkov, Dimitar" sort="Sajkov, Dimitar" uniqKey="Sajkov D" first="Dimitar" last="Sajkov">Dimitar Sajkov</name><affiliation wicri:level="1"><nlm:affiliation>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042</wicri:regionArea><wicri:noRegion>South Australia 5042</wicri:noRegion></affiliation></author><author><name sortKey="Honda Okubo, Yoshikazu" sort="Honda Okubo, Yoshikazu" uniqKey="Honda Okubo Y" first="Yoshikazu" last="Honda-Okubo">Yoshikazu Honda-Okubo</name><affiliation wicri:level="1"><nlm:affiliation>Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author><author><name sortKey="Wilks, Samuel H" sort="Wilks, Samuel H" uniqKey="Wilks S" first="Samuel H" last="Wilks">Samuel H. Wilks</name><affiliation wicri:level="4"><nlm:affiliation>Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK; World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK; World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ</wicri:regionArea><orgName type="university">Université de Cambridge</orgName><placeName><settlement type="city">Cambridge</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Angleterre de l'Est</region></placeName></affiliation></author><author><name sortKey="Aban, Malet" sort="Aban, Malet" uniqKey="Aban M" first="Malet" last="Aban">Malet Aban</name><affiliation wicri:level="1"><nlm:affiliation>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Barr, Ian G" sort="Barr, Ian G" uniqKey="Barr I" first="Ian G" last="Barr">Ian G. Barr</name><affiliation wicri:level="4"><nlm:affiliation>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia; Department of Microbiology & Immunology, University of Melbourne, Victoria 3000, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia; Department of Microbiology & Immunology, University of Melbourne, Victoria 3000</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Petrovsky, Nikolai" sort="Petrovsky, Nikolai" uniqKey="Petrovsky N" first="Nikolai" last="Petrovsky">Nikolai Petrovsky</name><affiliation wicri:level="1"><nlm:affiliation>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia; Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia. Electronic address: nikolai.petrovsky@flinders.edu.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia; Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042</wicri:regionArea><wicri:noRegion>Adelaide 5042</wicri:noRegion></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Adult</term><term>Antibodies, Viral (blood)</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Influenza A Virus, H3N2 Subtype</term><term>Influenza Vaccines (therapeutic use)</term><term>Influenza, Human (prevention & control)</term><term>Inulin (administration & dosage)</term><term>Inulin (analogs & derivatives)</term><term>Male</term><term>Middle Aged</term><term>Single-Blind Method</term><term>Vaccines, Inactivated (therapeutic use)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adjuvants immunologiques (administration et posologie)</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps antiviraux (sang)</term><term>Femelle</term><term>Grippe humaine ()</term><term>Humains</term><term>Inuline (administration et posologie)</term><term>Inuline (analogues et dérivés)</term><term>Mâle</term><term>Méthode en simple aveugle</term><term>Sous-type H3N2 du virus de la grippe A</term><term>Tests d'inhibition de l'hémagglutination</term><term>Vaccins antigrippaux (usage thérapeutique)</term><term>Vaccins inactivés (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Inulin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Inulin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Adjuvants immunologiques</term><term>Inuline</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Inuline</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Influenza A Virus, H3N2 Subtype</term><term>Male</term><term>Middle Aged</term><term>Single-Blind Method</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Mâle</term><term>Méthode en simple aveugle</term><term>Sous-type H3N2 du virus de la grippe A</term><term>Tests d'inhibition de l'hémagglutination</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Influenza vaccines are usually non-adjuvanted but addition of adjuvant may improve immunogenicity and permit dose-sparing, critical for vaccine supply in the event of an influenza pandemic. The aim of this first-in-man study was to determine the effect of delta inulin adjuvant on the safety and immunogenicity of a reduced dose seasonal influenza vaccine. Healthy male and female adults aged 18-65years were recruited to participate in a randomized controlled study to compare the safety, tolerability and immunogenicity of a reduced-dose 2007 Southern Hemisphere trivalent inactivated influenza vaccine formulated with Advax™ delta inulin adjuvant (LTIV+Adj) when compared to a full-dose of the standard TIV vaccine which does not contain an adjuvant. LTIV+Adj provided equivalent immunogenicity to standard TIV vaccine as assessed by hemagglutination inhibition (HI) assays against each vaccine strain as well as against a number of heterosubtypic strains. HI responses were sustained at 3months post-immunisation in both groups. Antibody landscapes against a large panel of H3N2 influenza viruses showed distinct age effects whereby subjects over 40years old had a bimodal baseline HI distribution pattern, with the highest HI titers against the very oldest H3N2 isolates and with a second HI peak against influenza isolates from the last 5-10years. By contrast, subjects >40years had a unimodal baseline HI distribution with peak recognition of H3N2 isolates from approximately 20years ago. The reduced dose TIV vaccine containing Advax adjuvant was well tolerated and no safety issues were identified. Hence, delta inulin may be a useful adjuvant for use in seasonal or pandemic influenza vaccines. Australia New Zealand Clinical Trial Registry: ACTRN12607000599471.</div></front></TEI></pubmed></double></record>Pour manipuler ce document sous Unix (Dilib)
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