A dose-ranging study of MF59®-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination
Identifieur interne : 000066 ( Pmc/Curation ); précédent : 000065; suivant : 000067A dose-ranging study of MF59®-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination
Auteurs : Keith S. Reisinger [États-Unis] ; Sandra J. Holmes [États-Unis] ; Paola Pedotti [États-Unis] ; Ashwani Kumar Arora [États-Unis] ; Maria Lattanzi [États-Unis]Source :
- Human Vaccines & Immunotherapeutics [ 2164-5515 ] ; 2014.
Abstract
Background
During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture.
Methods
Healthy subjects aged 18−64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59® adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo.
Results
All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant.
Conclusion
A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18−64 years) and older (≥65 years) adult populations.
Url:
DOI: 10.4161/hv.29393
PubMed: 25424947
PubMed Central: 4896790
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Holmes</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Pedotti, Paola" sort="Pedotti, Paola" uniqKey="Pedotti P" first="Paola" last="Pedotti">Paola Pedotti</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Arora, Ashwani Kumar" sort="Arora, Ashwani Kumar" uniqKey="Arora A" first="Ashwani Kumar" last="Arora">Ashwani Kumar Arora</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Lattanzi, Maria" sort="Lattanzi, Maria" uniqKey="Lattanzi M" first="Maria" last="Lattanzi">Maria Lattanzi</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25424947</idno><idno type="pmc">4896790</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896790</idno><idno type="RBID">PMC:4896790</idno><idno type="doi">10.4161/hv.29393</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000066</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000066</idno><idno type="wicri:Area/Pmc/Curation">000066</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000066</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A dose-ranging study of MF59<sup>®</sup>-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination</title><author><name sortKey="Reisinger, Keith S" sort="Reisinger, Keith S" uniqKey="Reisinger K" first="Keith S" last="Reisinger">Keith S. Reisinger</name><affiliation wicri:level="2"><nlm:aff id="A1">Primary Physicians Research, Medicine; Pittsburgh, PA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>Primary Physicians Research, Medicine; Pittsburgh</wicri:cityArea></affiliation></author><author><name sortKey="Holmes, Sandra J" sort="Holmes, Sandra J" uniqKey="Holmes S" first="Sandra J" last="Holmes">Sandra J. Holmes</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Pedotti, Paola" sort="Pedotti, Paola" uniqKey="Pedotti P" first="Paola" last="Pedotti">Paola Pedotti</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Arora, Ashwani Kumar" sort="Arora, Ashwani Kumar" uniqKey="Arora A" first="Ashwani Kumar" last="Arora">Ashwani Kumar Arora</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Lattanzi, Maria" sort="Lattanzi, Maria" uniqKey="Lattanzi M" first="Maria" last="Lattanzi">Maria Lattanzi</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author></analytic><series><title level="j">Human Vaccines & Immunotherapeutics</title><idno type="ISSN">2164-5515</idno><idno type="eISSN">2164-554X</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Background
</p><p>During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture.</p><p>Methods</p><p>Healthy subjects aged 18−64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59<sup>®</sup> adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo.</p><p>Results</p><p>All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant.</p><p>Conclusion</p><p>A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18−64 years) and older (≥65 years) adult populations.</p></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="iso-abbrev">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="pmc">KHVI</journal-id><journal-title-group><journal-title>Human Vaccines & Immunotherapeutics</journal-title></journal-title-group><issn pub-type="ppub">2164-5515</issn><issn pub-type="epub">2164-554X</issn><publisher><publisher-name>Taylor & Francis</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25424947</article-id><article-id pub-id-type="pmc">4896790</article-id><article-id pub-id-type="publisher-id">10929393</article-id><article-id pub-id-type="doi">10.4161/hv.29393</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Paper</subject></subj-group></article-categories><title-group><article-title>A dose-ranging study of MF59<sup>®</sup>-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Reisinger</surname><given-names>Keith S</given-names></name><xref ref-type="aff" rid="A1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Holmes</surname><given-names>Sandra J</given-names></name><xref ref-type="aff" rid="A2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pedotti</surname><given-names>Paola</given-names></name><xref ref-type="aff" rid="A2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Arora</surname><given-names>Ashwani Kumar</given-names></name><xref ref-type="aff" rid="A2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lattanzi</surname><given-names>Maria</given-names></name><xref ref-type="aff" rid="A2"><sup>2</sup></xref><xref ref-type="corresp" rid="cor1"><sup>*</sup></xref></contrib><aff id="A1"><label>1</label>Primary Physicians Research, Medicine; Pittsburgh, PA USA</aff><aff id="A2"><label>2</label>Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</aff></contrib-group><author-notes><corresp id="cor1"><label>*</label>Correspondence to: Maria Lattanzi, Email: <email xlink:href="maria.lattanzi@novartis.com">maria.lattanzi@novartis.com</email></corresp></author-notes><pub-date pub-type="collection"><month>8</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>19</day><month>6</month><year>2014</year></pub-date><volume>10</volume><issue>8</issue><fpage seq="33">2395</fpage><lpage>2407</lpage><history><date date-type="received" iso-8601-date="2014-04-04"><day>04</day><month>4</month><year>2014</year></date><date date-type="rev-recd" iso-8601-date="2014-05-19"><day>19</day><month>5</month><year>2014</year></date><date date-type="accepted" iso-8601-date="2014-05-28"><day>28</day><month>5</month><year>2014</year></date></history><permissions><copyright-statement>Copyright © 2014 Landes Bioscience</copyright-statement><copyright-year>2014</copyright-year><copyright-holder>Landes Bioscience</copyright-holder></permissions><self-uri content-type="pdf" xlink:href="khvi-10-08-10929393.pdf"></self-uri><abstract><p>Background
</p><p>During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture.</p><p>Methods</p><p>Healthy subjects aged 18−64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59<sup>®</sup> adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo.</p><p>Results</p><p>All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant.</p><p>Conclusion</p><p>A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18−64 years) and older (≥65 years) adult populations.</p></abstract><kwd-group kwd-group-type="author"><title>Keywords: </title><kwd>influenza</kwd><kwd>H1N1</kwd><kwd>vaccine</kwd><kwd>pandemic</kwd><kwd>MF59</kwd><kwd>adjuvant</kwd></kwd-group><counts><page-count count="13"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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