Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study.
Identifieur interne : 000035 ( Main/Exploration ); précédent : 000034; suivant : 000036Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study.
Auteurs : Paul Gillard [Belgique] ; Didier Giet ; Stéphane Heijmans ; Mamadou Dramé ; Karl Walravens ; François RomanSource :
- Trials [ 1745-6215 ] ; 2014.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adjuvants immunologiques (effets indésirables), Adulte d'âge moyen, Anticorps antiviraux (sang), Anticorps neutralisants (sang), Association médicamenteuse, Belgique, Calendrier vaccinal, Facteurs de l'âge, Facteurs temps, Femelle, Grippe humaine (), Grippe humaine (immunologie), Grippe humaine (sang), Grippe humaine (virologie), Humains, Immunité cellulaire (), Immunité humorale (), Lymphocytes T CD4+ (), Lymphocytes T CD4+ (immunologie), Lymphocytes T CD4+ (virologie), Marqueurs biologiques (sang), Mâle, Polysorbates (administration et posologie), Polysorbates (effets indésirables), Résultat thérapeutique, Sous-type H5N1 du virus de la grippe A (immunologie), Squalène (administration et posologie), Squalène (effets indésirables), Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Tests sérologiques, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), alpha-Tocophérol (administration et posologie), alpha-Tocophérol (effets indésirables), Études de suivi.
- MESH :
- administration et posologie : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux, alpha-Tocophérol.
- effets indésirables : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux, alpha-Tocophérol.
- immunologie : Grippe humaine, Lymphocytes T CD4+, Sous-type H5N1 du virus de la grippe A.
- sang : Anticorps antiviraux, Anticorps neutralisants, Grippe humaine, Marqueurs biologiques.
- virologie : Grippe humaine, Lymphocytes T CD4+.
- Adulte d'âge moyen, Association médicamenteuse, Belgique, Calendrier vaccinal, Facteurs de l'âge, Facteurs temps, Femelle, Grippe humaine, Humains, Immunité cellulaire, Immunité humorale, Lymphocytes T CD4+, Mâle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Tests sérologiques, Études de suivi.
- Wicri :
- geographic : Belgique.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adjuvants, Immunologic (adverse effects), Age Factors, Aged, Aged, 80 and over, Antibodies, Neutralizing (blood), Antibodies, Viral (blood), Belgium, Biomarkers (blood), CD4-Positive T-Lymphocytes (drug effects), CD4-Positive T-Lymphocytes (immunology), CD4-Positive T-Lymphocytes (virology), Drug Combinations, Female, Follow-Up Studies, Hemagglutination Inhibition Tests, Humans, Immunity, Cellular (drug effects), Immunity, Humoral (drug effects), Immunization Schedule, Influenza A Virus, H5N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (blood), Influenza, Human (immunology), Influenza, Human (prevention & control), Influenza, Human (virology), Male, Middle Aged, Polysorbates (administration & dosage), Polysorbates (adverse effects), Serologic Tests, Squalene (administration & dosage), Squalene (adverse effects), Time Factors, Treatment Outcome, alpha-Tocopherol (administration & dosage), alpha-Tocopherol (adverse effects).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene, alpha-Tocopherol.
- chemical , adverse effects : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene, alpha-Tocopherol.
- chemical , blood : Antibodies, Neutralizing, Antibodies, Viral, Biomarkers.
- geographic : Belgium, Drug Combinations.
- blood : Influenza, Human.
- drug effects : CD4-Positive T-Lymphocytes, Immunity, Cellular, Immunity, Humoral.
- immunology : CD4-Positive T-Lymphocytes, Influenza A Virus, H5N1 Subtype, Influenza, Human.
- prevention & control : Influenza, Human.
- virology : CD4-Positive T-Lymphocytes, Influenza, Human.
- Age Factors, Aged, Aged, 80 and over, Female, Follow-Up Studies, Hemagglutination Inhibition Tests, Humans, Immunization Schedule, Male, Middle Aged, Serologic Tests, Time Factors, Treatment Outcome.
Abstract
BACKGROUND
Older individuals often have a reduced immune response to influenza vaccination, which might be improved by administering a higher vaccine dose. We compared the immune response to two single doses of the AS03A-adjuvanted H5N1 pandemic vaccine (3.75 μg hemagglutinin of A/Vietnam/1194/2004) with that of two double vaccine doses (7.5 μg hemagglutinin) in adults aged ≥61 years. Here we report the 2-year persistence of the humoral and cellular immune response.
METHODS
In this phase II, open-label study, healthy participants aged 61 to 88 years (median 68 years) were randomised (3:1:3:1) to receive two single doses of the AS03A-adjuvanted vaccine (1xH5N1-AS) or the non-adjuvanted vaccine (1xH5N1), or two double doses of the AS03A-adjuvanted vaccine (2xH5N1-AS) or the non-adjuvanted vaccine (2xH5N1), 21 days apart. Serum haemagglutination inhibition antibodies and cellular immune responses against A/Vietnam/1194/2004 were measured in all groups at months 12 and 24; neutralising antibodies were assessed in a subset of the adjuvanted groups. Serious adverse events and adverse events of specific interest were recorded.
RESULTS
At month 24, haemagglutination inhibition antibody seroprotection rates were 37.2% (95% CI 27.0% to 48.3%) for 1xH5N1-AS, 30.9% (95% CI 21.1% to 42.1%) for 2xH5N1-AS, 16.2% (95% CI 6.2% to 32.0%) for 1xH5N1, and 8.3% (95% CI 1.0% to 27.0%) for 2xH5N1. Haemagglutination inhibition antibody geometric mean titres were 17.6 (95% CI 13.7 to 22.5) for 1xH5N1-AS, 18.4 (95% CI 14.2 to 23.8) for 2xH5N1-AS, 12.3 (95% CI 8.9 to 16.9) for 1xH5N1 and 9.8 (95% CI 6.7 to 14.4) for 2xH5N1. The median frequency of antigen-specific CD4+ T cells per 106 T cells (25th quartile; 75th quartile) was 852 (482; 1477) for 1xH5N1-AS, 1147 (662; 1698) for 2xH5N1-AS, 556 (343; 749) for 1x-H5N1 and 673 (465; 1497) for 2xH5N1. Neutralising antibody geometric mean titres were 391.0 (95% CI 295.5 to 517.5) in the 1xH5N1-AS group and 382.8 (95% CI 317.4 to 461.6) in the 2xH5N1-AS group.
CONCLUSIONS
Antibody levels declined substantially in all groups. Seroprotection rates, geometric mean titres for haemagglutination inhibition antibodies, and CD4+ T-cell responses tended to be higher in the AS03A-adjuvanted groups. There was no clear benefit, in terms of long-term persistence of the immune response, of doubling the dose of the adjuvanted vaccine. No safety concern was observed up to 24 months post-primary vaccination.
TRIAL REGISTRATION
NCT00397215 (7 November 2006).
DOI: 10.1186/1745-6215-15-419
PubMed: 25354581
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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uniqKey="Drame M" first="Mamadou" last="Dramé">Mamadou Dramé</name></author><author><name sortKey="Walravens, Karl" sort="Walravens, Karl" uniqKey="Walravens K" first="Karl" last="Walravens">Karl Walravens</name></author><author><name sortKey="Roman, Francois" sort="Roman, Francois" uniqKey="Roman F" first="François" last="Roman">François Roman</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:25354581</idno><idno type="pmid">25354581</idno><idno type="doi">10.1186/1745-6215-15-419</idno><idno type="wicri:Area/Main/Corpus">000033</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000033</idno><idno type="wicri:Area/Main/Curation">000033</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000033</idno><idno type="wicri:Area/Main/Exploration">000033</idno></publicationStmt><sourceDesc><biblStruct><analytic><title 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CD4+</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>CD4-Positive T-Lymphocytes</term><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Age Factors</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Follow-Up Studies</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Immunization Schedule</term><term>Male</term><term>Middle Aged</term><term>Serologic Tests</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Association médicamenteuse</term><term>Belgique</term><term>Calendrier vaccinal</term><term>Facteurs de l'âge</term><term>Facteurs temps</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Immunité cellulaire</term><term>Immunité humorale</term><term>Lymphocytes T CD4+</term><term>Mâle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Tests d'inhibition de l'hémagglutination</term><term>Tests sérologiques</term><term>Études de suivi</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Belgique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Older individuals often have a reduced immune response to influenza vaccination, which might be improved by administering a higher vaccine dose. We compared the immune response to two single doses of the AS03A-adjuvanted H5N1 pandemic vaccine (3.75 μg hemagglutinin of A/Vietnam/1194/2004) with that of two double vaccine doses (7.5 μg hemagglutinin) in adults aged ≥61 years. Here we report the 2-year persistence of the humoral and cellular immune response.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>In this phase II, open-label study, healthy participants aged 61 to 88 years (median 68 years) were randomised (3:1:3:1) to receive two single doses of the AS03A-adjuvanted vaccine (1xH5N1-AS) or the non-adjuvanted vaccine (1xH5N1), or two double doses of the AS03A-adjuvanted vaccine (2xH5N1-AS) or the non-adjuvanted vaccine (2xH5N1), 21 days apart. Serum haemagglutination inhibition antibodies and cellular immune responses against A/Vietnam/1194/2004 were measured in all groups at months 12 and 24; neutralising antibodies were assessed in a subset of the adjuvanted groups. Serious adverse events and adverse events of specific interest were recorded.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>At month 24, haemagglutination inhibition antibody seroprotection rates were 37.2% (95% CI 27.0% to 48.3%) for 1xH5N1-AS, 30.9% (95% CI 21.1% to 42.1%) for 2xH5N1-AS, 16.2% (95% CI 6.2% to 32.0%) for 1xH5N1, and 8.3% (95% CI 1.0% to 27.0%) for 2xH5N1. Haemagglutination inhibition antibody geometric mean titres were 17.6 (95% CI 13.7 to 22.5) for 1xH5N1-AS, 18.4 (95% CI 14.2 to 23.8) for 2xH5N1-AS, 12.3 (95% CI 8.9 to 16.9) for 1xH5N1 and 9.8 (95% CI 6.7 to 14.4) for 2xH5N1. The median frequency of antigen-specific CD4+ T cells per 106 T cells (25th quartile; 75th quartile) was 852 (482; 1477) for 1xH5N1-AS, 1147 (662; 1698) for 2xH5N1-AS, 556 (343; 749) for 1x-H5N1 and 673 (465; 1497) for 2xH5N1. Neutralising antibody geometric mean titres were 391.0 (95% CI 295.5 to 517.5) in the 1xH5N1-AS group and 382.8 (95% CI 317.4 to 461.6) in the 2xH5N1-AS group.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Antibody levels declined substantially in all groups. Seroprotection rates, geometric mean titres for haemagglutination inhibition antibodies, and CD4+ T-cell responses tended to be higher in the AS03A-adjuvanted groups. There was no clear benefit, in terms of long-term persistence of the immune response, of doubling the dose of the adjuvanted vaccine. No safety concern was observed up to 24 months post-primary vaccination.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>NCT00397215 (7 November 2006).</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25354581</PMID><DateCompleted><Year>2015</Year><Month>07</Month><Day>08</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><PubDate><Year>2014</Year><Month>Oct</Month><Day>29</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study.</ArticleTitle><Pagination><MedlinePgn>419</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/1745-6215-15-419</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Older individuals often have a reduced immune response to influenza vaccination, which might be improved by administering a higher vaccine dose. We compared the immune response to two single doses of the AS03A-adjuvanted H5N1 pandemic vaccine (3.75 μg hemagglutinin of A/Vietnam/1194/2004) with that of two double vaccine doses (7.5 μg hemagglutinin) in adults aged ≥61 years. Here we report the 2-year persistence of the humoral and cellular immune response.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In this phase II, open-label study, healthy participants aged 61 to 88 years (median 68 years) were randomised (3:1:3:1) to receive two single doses of the AS03A-adjuvanted vaccine (1xH5N1-AS) or the non-adjuvanted vaccine (1xH5N1), or two double doses of the AS03A-adjuvanted vaccine (2xH5N1-AS) or the non-adjuvanted vaccine (2xH5N1), 21 days apart. Serum haemagglutination inhibition antibodies and cellular immune responses against A/Vietnam/1194/2004 were measured in all groups at months 12 and 24; neutralising antibodies were assessed in a subset of the adjuvanted groups. Serious adverse events and adverse events of specific interest were recorded.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">At month 24, haemagglutination inhibition antibody seroprotection rates were 37.2% (95% CI 27.0% to 48.3%) for 1xH5N1-AS, 30.9% (95% CI 21.1% to 42.1%) for 2xH5N1-AS, 16.2% (95% CI 6.2% to 32.0%) for 1xH5N1, and 8.3% (95% CI 1.0% to 27.0%) for 2xH5N1. Haemagglutination inhibition antibody geometric mean titres were 17.6 (95% CI 13.7 to 22.5) for 1xH5N1-AS, 18.4 (95% CI 14.2 to 23.8) for 2xH5N1-AS, 12.3 (95% CI 8.9 to 16.9) for 1xH5N1 and 9.8 (95% CI 6.7 to 14.4) for 2xH5N1. The median frequency of antigen-specific CD4+ T cells per 106 T cells (25th quartile; 75th quartile) was 852 (482; 1477) for 1xH5N1-AS, 1147 (662; 1698) for 2xH5N1-AS, 556 (343; 749) for 1x-H5N1 and 673 (465; 1497) for 2xH5N1. Neutralising antibody geometric mean titres were 391.0 (95% CI 295.5 to 517.5) in the 1xH5N1-AS group and 382.8 (95% CI 317.4 to 461.6) in the 2xH5N1-AS group.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Antibody levels declined substantially in all groups. Seroprotection rates, geometric mean titres for haemagglutination inhibition antibodies, and CD4+ T-cell responses tended to be higher in the AS03A-adjuvanted groups. There was no clear benefit, in terms of long-term persistence of the immune response, of doubling the dose of the adjuvanted vaccine. No safety concern was observed up to 24 months post-primary vaccination.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">NCT00397215 (7 November 2006).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gillard</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>GSK Vaccines, Wavre, Belgium. paul.gillard@gsk.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Giet</LastName><ForeName>Didier</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Heijmans</LastName><ForeName>Stéphane</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Dramé</LastName><ForeName>Mamadou</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Walravens</LastName><ForeName>Karl</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Roman</LastName><ForeName>François</ForeName><Initials>F</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00397215</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>10</Month><Day>29</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C550253">ASO3B adjuvant</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000276">Adjuvants, Immunologic</NameOfSubstance></Chemical><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="D015415">Biomarkers</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011136">Polysorbates</NameOfSubstance></Chemical><Chemical><RegistryNumber>7QWM220FJH</RegistryNumber><NameOfSubstance UI="D013185">Squalene</NameOfSubstance></Chemical><Chemical><RegistryNumber>H4N855PNZ1</RegistryNumber><NameOfSubstance UI="D024502">alpha-Tocopherol</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</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="D001530" MajorTopicYN="N" Type="Geographic">Belgium</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015415" MajorTopicYN="N">Biomarkers</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015496" MajorTopicYN="N">CD4-Positive T-Lymphocytes</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</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="D007111" MajorTopicYN="N">Immunity, Cellular</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D056724" MajorTopicYN="N">Immunity, Humoral</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007115" MajorTopicYN="N">Immunization Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053124" MajorTopicYN="N">Influenza A Virus, H5N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">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></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012698" MajorTopicYN="N">Serologic Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D024502" MajorTopicYN="N">alpha-Tocopherol</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year><Month>10</Month><Day>31</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>10</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>10</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>10</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>7</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25354581</ArticleId><ArticleId IdType="pii">1745-6215-15-419</ArticleId><ArticleId IdType="doi">10.1186/1745-6215-15-419</ArticleId><ArticleId IdType="pmc">PMC4233031</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>J Clin Microbiol. 1999 Apr;37(4):937-43</Citation><ArticleIdList><ArticleId IdType="pubmed">10074505</ArticleId></ArticleIdList></Reference><Reference><Citation>BMC Infect Dis. 2014;14:142</Citation><ArticleIdList><ArticleId IdType="pubmed">24628789</ArticleId></ArticleIdList></Reference><Reference><Citation>J Immunol. 2006 May 15;176(10):6333-9</Citation><ArticleIdList><ArticleId IdType="pubmed">16670345</ArticleId></ArticleIdList></Reference><Reference><Citation>Nature. 2006 Jul 27;442(7101):448-52</Citation><ArticleIdList><ArticleId IdType="pubmed">16642006</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2007 Aug 18;370(9587):580-9</Citation><ArticleIdList><ArticleId IdType="pubmed">17707753</ArticleId></ArticleIdList></Reference><Reference><Citation>PLoS One. 2008;3(2):e1665</Citation><ArticleIdList><ArticleId IdType="pubmed">18301743</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Infect Dis. 2008 Apr 1;46(7):1078-84</Citation><ArticleIdList><ArticleId IdType="pubmed">18444828</ArticleId></ArticleIdList></Reference><Reference><Citation>J Infect Dis. 2008 Sep 1;198(5):632-4</Citation><ArticleIdList><ArticleId IdType="pubmed">18652548</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2009 Apr 21;27(18):2418-25</Citation><ArticleIdList><ArticleId IdType="pubmed">19368783</ArticleId></ArticleIdList></Reference><Reference><Citation>Proc Natl Acad Sci U S A. 2009 May 12;106(19):7962-7</Citation><ArticleIdList><ArticleId IdType="pubmed">19416838</ArticleId></ArticleIdList></Reference><Reference><Citation>Emerg Infect Dis. 2009 Aug;15(8):1252-9</Citation><ArticleIdList><ArticleId IdType="pubmed">19751587</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2009 Oct 23;27(45):6284-90</Citation><ArticleIdList><ArticleId IdType="pubmed">19856521</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2009 Dec 9;27(52):7428-35</Citation><ArticleIdList><ArticleId IdType="pubmed">19683087</ArticleId></ArticleIdList></Reference><Reference><Citation>Pediatr Infect Dis J. 2010 Jun;29(6):e35-46</Citation><ArticleIdList><ArticleId IdType="pubmed">20375709</ArticleId></ArticleIdList></Reference><Reference><Citation>J Infect Dis. 2011 Apr 15;203(8):1054-62</Citation><ArticleIdList><ArticleId IdType="pubmed">21450995</ArticleId></ArticleIdList></Reference><Reference><Citation>J Infect Dis. 2011 Jun 15;203(12):1729-38</Citation><ArticleIdList><ArticleId IdType="pubmed">21606531</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2012 Feb 8;30(7):1388-96</Citation><ArticleIdList><ArticleId IdType="pubmed">22192847</ArticleId></ArticleIdList></Reference><Reference><Citation>J Infect Dis. 2012 Jul 15;206(2):158-66</Citation><ArticleIdList><ArticleId IdType="pubmed">22551811</ArticleId></ArticleIdList></Reference><Reference><Citation>Science. 2012 Jun 22;336(6088):1531-3</Citation><ArticleIdList><ArticleId IdType="pubmed">22723412</ArticleId></ArticleIdList></Reference><Reference><Citation>Influenza Other Respir Viruses. 2013 Jan;7(1):55-65</Citation><ArticleIdList><ArticleId IdType="pubmed">22405557</ArticleId></ArticleIdList></Reference><Reference><Citation>Proc Natl Acad Sci U S A. 2006 Apr 11;103(15):5935-40</Citation><ArticleIdList><ArticleId IdType="pubmed">16585506</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Belgique</li></country></list><tree><noCountry><name sortKey="Drame, Mamadou" sort="Drame, Mamadou" uniqKey="Drame M" first="Mamadou" last="Dramé">Mamadou Dramé</name><name sortKey="Giet, Didier" sort="Giet, Didier" uniqKey="Giet D" first="Didier" last="Giet">Didier Giet</name><name sortKey="Heijmans, Stephane" sort="Heijmans, Stephane" uniqKey="Heijmans S" first="Stéphane" last="Heijmans">Stéphane Heijmans</name><name sortKey="Roman, Francois" sort="Roman, Francois" uniqKey="Roman F" first="François" last="Roman">François Roman</name><name sortKey="Walravens, Karl" sort="Walravens, Karl" uniqKey="Walravens K" first="Karl" last="Walravens">Karl Walravens</name></noCountry><country name="Belgique"><noRegion><name sortKey="Gillard, Paul" sort="Gillard, Paul" uniqKey="Gillard P" first="Paul" last="Gillard">Paul 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