Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study.
Identifieur interne : 000199 ( PubMed/Corpus ); précédent : 000198; suivant : 000200Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study.
Auteurs : Pierre Van Damme ; Robert Arnou ; Froukje Kafeja ; Anne Fiquet ; Patrick Richard ; Stéphane Thomas ; Gilles Meghlaoui ; Sandrine Isabelle Samson ; Emilio LedesmaSource :
- BMC infectious diseases [ 1471-2334 ] ; 2010.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Aged, Aged, 80 and over, Antibodies, Viral (blood), Female, Hemagglutination Inhibition Tests, Human Experimentation, Humans, Immunodiffusion, Influenza A Virus, H1N1 Subtype (immunology), Influenza A Virus, H2N2 Subtype (immunology), Influenza B virus (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (immunology), Influenza, Human (prevention & control), Injections, Intradermal, Injections, Intramuscular, Male, Polysorbates (administration & dosage), Squalene (administration & dosage), Vaccines, Subunit (administration & dosage), Vaccines, Subunit (adverse effects), Vaccines, Subunit (immunology).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene, Vaccines, Subunit.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Subunit.
- chemical , blood : Antibodies, Viral.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza A Virus, H2N2 Subtype, Influenza B virus, Influenza Vaccines, Influenza, Human, Vaccines, Subunit.
- prevention & control : Influenza, Human.
- Aged, Aged, 80 and over, Female, Hemagglutination Inhibition Tests, Human Experimentation, Humans, Immunodiffusion, Injections, Intradermal, Injections, Intramuscular, Male.
Abstract
Although seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an intradermal vaccination route. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly.
DOI: 10.1186/1471-2334-10-134
PubMed: 20504306
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pubmed:20504306Le document en format XML
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first="Patrick" last="Richard">Patrick Richard</name></author><author><name sortKey="Thomas, Stephane" sort="Thomas, Stephane" uniqKey="Thomas S" first="Stéphane" last="Thomas">Stéphane Thomas</name></author><author><name sortKey="Meghlaoui, Gilles" sort="Meghlaoui, Gilles" uniqKey="Meghlaoui G" first="Gilles" last="Meghlaoui">Gilles Meghlaoui</name></author><author><name sortKey="Samson, Sandrine Isabelle" sort="Samson, Sandrine Isabelle" uniqKey="Samson S" first="Sandrine Isabelle" last="Samson">Sandrine Isabelle Samson</name></author><author><name sortKey="Ledesma, Emilio" sort="Ledesma, Emilio" uniqKey="Ledesma E" first="Emilio" last="Ledesma">Emilio Ledesma</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="RBID">pubmed:20504306</idno><idno type="pmid">20504306</idno><idno type="doi">10.1186/1471-2334-10-134</idno><idno type="wicri:Area/PubMed/Corpus">000199</idno><idno type="wicri:explorRef" 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Fiquet</name></author><author><name sortKey="Richard, Patrick" sort="Richard, Patrick" uniqKey="Richard P" first="Patrick" last="Richard">Patrick Richard</name></author><author><name sortKey="Thomas, Stephane" sort="Thomas, Stephane" uniqKey="Thomas S" first="Stéphane" last="Thomas">Stéphane Thomas</name></author><author><name sortKey="Meghlaoui, Gilles" sort="Meghlaoui, Gilles" uniqKey="Meghlaoui G" first="Gilles" last="Meghlaoui">Gilles Meghlaoui</name></author><author><name sortKey="Samson, Sandrine Isabelle" sort="Samson, Sandrine Isabelle" uniqKey="Samson S" first="Sandrine Isabelle" last="Samson">Sandrine Isabelle Samson</name></author><author><name sortKey="Ledesma, Emilio" sort="Ledesma, Emilio" uniqKey="Ledesma E" first="Emilio" last="Ledesma">Emilio Ledesma</name></author></analytic><series><title level="j">BMC infectious diseases</title><idno type="eISSN">1471-2334</idno><imprint><date when="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Aged</term><term>Aged, 80 and over</term><term>Antibodies, Viral (blood)</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Human Experimentation</term><term>Humans</term><term>Immunodiffusion</term><term>Influenza A Virus, H1N1 Subtype (immunology)</term><term>Influenza A Virus, H2N2 Subtype (immunology)</term><term>Influenza B virus (immunology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (immunology)</term><term>Influenza, Human (prevention & control)</term><term>Injections, Intradermal</term><term>Injections, Intramuscular</term><term>Male</term><term>Polysorbates (administration & dosage)</term><term>Squalene (administration & dosage)</term><term>Vaccines, Subunit (administration & dosage)</term><term>Vaccines, Subunit (adverse effects)</term><term>Vaccines, Subunit (immunology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Influenza Vaccines</term><term>Polysorbates</term><term>Squalene</term><term>Vaccines, Subunit</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Subunit</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term><term>Influenza A Virus, H2N2 Subtype</term><term>Influenza B virus</term><term>Influenza Vaccines</term><term>Influenza, Human</term><term>Vaccines, Subunit</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Human Experimentation</term><term>Humans</term><term>Immunodiffusion</term><term>Injections, Intradermal</term><term>Injections, Intramuscular</term><term>Male</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Although seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an intradermal vaccination route. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">20504306</PMID><DateCompleted><Year>2010</Year><Month>09</Month><Day>24</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1471-2334</ISSN><JournalIssue CitedMedium="Internet"><Volume>10</Volume><PubDate><Year>2010</Year><Month>May</Month><Day>26</Day></PubDate></JournalIssue><Title>BMC infectious diseases</Title><ISOAbbreviation>BMC Infect. Dis.</ISOAbbreviation></Journal><ArticleTitle>Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study.</ArticleTitle><Pagination><MedlinePgn>134</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/1471-2334-10-134</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Although seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an intradermal vaccination route. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Elderly volunteers (age > or = 65 years) were randomised to receive a single dose of trivalent seasonal influenza vaccine: either a split-virion vaccine containing 15 microg haemagglutinin [HA]/strain/0.1-ml dose administered intradermally, or a subunit vaccine (15 microg HA/strain/0.5-ml dose) adjuvanted with MF59C.1 and administered intramuscularly. Blood samples were taken before and 21 +/- 3 days post-vaccination. Anti-HA antibody titres were assessed using haemagglutination inhibition (HI) and single radial haemolysis (SRH) methods. We aimed to show that the intradermal vaccine was non-inferior to the adjuvanted vaccine.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 795 participants were enrolled (intradermal vaccine n = 398; adjuvanted vaccine n = 397). Non-inferiority of the intradermal vaccine was demonstrated for the A/H1N1 and B strains, but not for the A/H3N2 strain (upper bound of the 95% CI = 1.53) using the HI method, and for all three strains by the SRH method. A post-hoc analysis of covariance to adjust for baseline antibody titres demonstrated the non-inferiority of the intradermal vaccine by HI and SRH methods for all three strains. Both vaccines were, in general, well tolerated; the incidence of injection-site reactions was higher for the intradermal (70.1%) than the adjuvanted vaccine (33.8%) but these reactions were mild and of short duration.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The immunogenicity and safety of the intradermal seasonal influenza vaccine in the elderly was comparable with that of the adjuvanted vaccine. Intradermal vaccination to target the immune properties of the skin appears to be an appropriate strategy to address the challenge of declining immune responses in the elderly.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov: NCT00554333.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Van Damme</LastName><ForeName>Pierre</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>University of Antwerp, Wilrijk, Belgium. pierre.vandamme@ua.ac.be</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Arnou</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Kafeja</LastName><ForeName>Froukje</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Fiquet</LastName><ForeName>Anne</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Richard</LastName><ForeName>Patrick</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Stéphane</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Meghlaoui</LastName><ForeName>Gilles</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Samson</LastName><ForeName>Sandrine Isabelle</ForeName><Initials>SI</Initials></Author><Author ValidYN="Y"><LastName>Ledesma</LastName><ForeName>Emilio</ForeName><Initials>E</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00554333</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2010</Year><Month>05</Month><Day>26</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMC Infect Dis</MedlineTA><NlmUniqueID>100968551</NlmUniqueID><ISSNLinking>1471-2334</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="C089950">MF59 oil emulsion</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance 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MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007271" MajorTopicYN="N">Injections, Intradermal</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007273" MajorTopicYN="N">Injections, Intramuscular</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" 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