Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant.
Identifieur interne : 000521 ( PubMed/Curation ); précédent : 000520; suivant : 000522Human 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 [ 1873-2518 ] ; 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
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.
DOI: 10.1016/j.vaccine.2016.05.071
PubMed: 27342914
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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></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></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></affiliation></author><author><name sortKey="Wilks, Samuel H" sort="Wilks, Samuel H" uniqKey="Wilks S" first="Samuel H" last="Wilks">Samuel H. 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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><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27342914</PMID><DateCompleted><Year>2017</Year><Month>11</Month><Day>02</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>34</Volume><Issue>33</Issue><PubDate><Year>2016</Year><Month>07</Month><Day>19</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant.</ArticleTitle><Pagination><MedlinePgn>3780-6</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2016.05.071</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(16)30397-8</ELocationID><Abstract><AbstractText>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.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gordon</LastName><ForeName>David L</ForeName><Initials>DL</Initials><AffiliationInfo><Affiliation>Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, and Flinders University, South Australia 5042, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sajkov</LastName><ForeName>Dimitar</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Australian Respiratory and Sleep Medicine Institute, Adelaide, South Australia 5042, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Honda-Okubo</LastName><ForeName>Yoshikazu</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Endocrinology, Flinders University, 5042, Australia; Vaxine Pty Ltd, Flinders Medical Centre, Adelaide 5042, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wilks</LastName><ForeName>Samuel H</ForeName><Initials>SH</Initials><AffiliationInfo><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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aban</LastName><ForeName>Malet</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>WHO Collaborating Centre for Reference and Research on Influenza (VIDRL), Peter Doherty Institute for Infection & Immunity, 792 Elizabeth Street, Melbourne 3000, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barr</LastName><ForeName>Ian G</ForeName><Initials>IG</Initials><AffiliationInfo><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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Petrovsky</LastName><ForeName>Nikolai</ForeName><Initials>N</Initials><AffiliationInfo><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.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ANZCTR</DataBankName><AccessionNumberList><AccessionNumber>ACTRN12607000599471</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>HHSN272200800039C</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>U01 AI061142</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>06</Month><Day>21</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="D000276">Adjuvants, Immunologic</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015164">Vaccines, Inactivated</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C576871">advax</NameOfSubstance></Chemical><Chemical><RegistryNumber>9005-80-5</RegistryNumber><NameOfSubstance UI="D007444">Inulin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006385" MajorTopicYN="N">Hemagglutination Inhibition Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053122" MajorTopicYN="N">Influenza A Virus, H3N2 Subtype</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007444" MajorTopicYN="N">Inulin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016037" MajorTopicYN="N">Single-Blind 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