Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations
Identifieur interne : 000862 ( Pmc/Curation ); précédent : 000861; suivant : 000863Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations
Auteurs : Sharon E. Frey ; David I. Bernstein ; Rebecca C. Brady ; Wendy A. Keitel ; Hana El Sahly ; Nadine Georges Rouphael ; Mark J. Mulligan ; Robert L. Atmar ; Srilatha Edupuganti ; Shital M. Patel ; Michelle Dickey ; Irene Graham ; Edwin L. Anderson ; Diana L. Noah ; Heather Hill ; Mark Wolff ; Robert B. BelsheSource :
- Vaccine [ 0264-410X ] ; 2014.
Abstract
During the 2009 influenza pandemic both seasonal and 2009 pandemic vaccines were recommended. We conducted a randomized trial of monovalent 2009-H1N1 vaccine and seasonal trivalent inactivated influenza vaccine (IIV3) given sequentially or concurrently to adults.
Adults randomized to 4 study groups and stratified by age (18-64 and ≥65 years) received 1 dose of seasonal IIV3 or placebo and 2 doses of 2009-H1N1 vaccine or placebo in one of 4 combinations, i.e., H1N1+Placebo/H1N1+Placebo/
Eight hundred-five (805) adults were enrolled. All combinations of vaccines were safe and well tolerated. In general, one dose of 2009-H1N1 and one dose of IIV3, regardless of sequence or concurrency of administration, were immunogenic in adults. There were no significant differences in geometric mean titers (GMT) or the proportions of subjects with ≥4-fold rise in antibody responses and titers ≥40 for any vaccine group or between age strata for 2009-H1N1 after the first or second dose, although the vaccine sequence affected the titers to the IIV3 antigens. Hemagglutination inhibition antibody (HAI) GMTs against 2009-H1N1 for the combined age strata 21 days after the first 2009-H1N1 dose were 190.4, 182.1, 232.9 and 157.5 for HP/HP/
All vaccine combinations were generally well tolerated. Immune responses to one dose of 2009-H1N1 were adequate regardless of the sequence of vaccination in all age groups, but the sequence affected titers to IIV3 antigens.
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DOI: 10.1016/j.vaccine.2014.10.083
PubMed: 25444805
PubMed Central: 4293632
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David I. Bernstein<affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations</title><author><name sortKey="Frey, Sharon E" sort="Frey, Sharon E" uniqKey="Frey S" first="Sharon E." last="Frey">Sharon E. Frey</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Bernstein, David I" sort="Bernstein, David I" uniqKey="Bernstein D" first="David I." last="Bernstein">David I. Bernstein</name><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation></author><author><name sortKey="Brady, Rebecca C" sort="Brady, Rebecca C" uniqKey="Brady R" first="Rebecca C." last="Brady">Rebecca C. Brady</name><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation></author><author><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Sahly, Hana El" sort="Sahly, Hana El" uniqKey="Sahly H" first="Hana El" last="Sahly">Hana El Sahly</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Rouphael, Nadine Georges" sort="Rouphael, Nadine Georges" uniqKey="Rouphael N" first="Nadine Georges" last="Rouphael">Nadine Georges Rouphael</name><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Mulligan, Mark J" sort="Mulligan, Mark J" uniqKey="Mulligan M" first="Mark J." last="Mulligan">Mark J. Mulligan</name><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Atmar, Robert L" sort="Atmar, Robert L" uniqKey="Atmar R" first="Robert L." last="Atmar">Robert L. Atmar</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Edupuganti, Srilatha" sort="Edupuganti, Srilatha" uniqKey="Edupuganti S" first="Srilatha" last="Edupuganti">Srilatha Edupuganti</name><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Dickey, Michelle" sort="Dickey, Michelle" uniqKey="Dickey M" first="Michelle" last="Dickey">Michelle Dickey</name><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation></author><author><name sortKey="Graham, Irene" sort="Graham, Irene" uniqKey="Graham I" first="Irene" last="Graham">Irene Graham</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Anderson, Edwin L" sort="Anderson, Edwin L" uniqKey="Anderson E" first="Edwin L." last="Anderson">Edwin L. Anderson</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name><affiliation><nlm:aff id="A5">Southern Research Institute</nlm:aff></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation><nlm:aff id="A6">The EMMES Corporation</nlm:aff></affiliation></author><author><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name><affiliation><nlm:aff id="A6">The EMMES Corporation</nlm:aff></affiliation></author><author><name sortKey="Belshe, Robert B" sort="Belshe, Robert B" uniqKey="Belshe R" first="Robert B." last="Belshe">Robert B. Belshe</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25444805</idno><idno type="pmc">4293632</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4293632</idno><idno type="RBID">PMC:4293632</idno><idno type="doi">10.1016/j.vaccine.2014.10.083</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000862</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000862</idno><idno type="wicri:Area/Pmc/Curation">000862</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000862</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations</title><author><name sortKey="Frey, Sharon E" sort="Frey, Sharon E" uniqKey="Frey S" first="Sharon E." last="Frey">Sharon E. Frey</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Bernstein, David I" sort="Bernstein, David I" uniqKey="Bernstein D" first="David I." last="Bernstein">David I. Bernstein</name><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation></author><author><name sortKey="Brady, Rebecca C" sort="Brady, Rebecca C" uniqKey="Brady R" first="Rebecca C." last="Brady">Rebecca C. Brady</name><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation></author><author><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Sahly, Hana El" sort="Sahly, Hana El" uniqKey="Sahly H" first="Hana El" last="Sahly">Hana El Sahly</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Rouphael, Nadine Georges" sort="Rouphael, Nadine Georges" uniqKey="Rouphael N" first="Nadine Georges" last="Rouphael">Nadine Georges Rouphael</name><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Mulligan, Mark J" sort="Mulligan, Mark J" uniqKey="Mulligan M" first="Mark J." last="Mulligan">Mark J. Mulligan</name><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Atmar, Robert L" sort="Atmar, Robert L" uniqKey="Atmar R" first="Robert L." last="Atmar">Robert L. Atmar</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Edupuganti, Srilatha" sort="Edupuganti, Srilatha" uniqKey="Edupuganti S" first="Srilatha" last="Edupuganti">Srilatha Edupuganti</name><affiliation><nlm:aff id="A4">The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</nlm:aff><wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name><affiliation><nlm:aff id="A3">Baylor College of Medicine</nlm:aff></affiliation></author><author><name sortKey="Dickey, Michelle" sort="Dickey, Michelle" uniqKey="Dickey M" first="Michelle" last="Dickey">Michelle Dickey</name><affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff><wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry></affiliation></author><author><name sortKey="Graham, Irene" sort="Graham, Irene" uniqKey="Graham I" first="Irene" last="Graham">Irene Graham</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Anderson, Edwin L" sort="Anderson, Edwin L" uniqKey="Anderson E" first="Edwin L." last="Anderson">Edwin L. Anderson</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name><affiliation><nlm:aff id="A5">Southern Research Institute</nlm:aff></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation><nlm:aff id="A6">The EMMES Corporation</nlm:aff></affiliation></author><author><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name><affiliation><nlm:aff id="A6">The EMMES Corporation</nlm:aff></affiliation></author><author><name sortKey="Belshe, Robert B" sort="Belshe, Robert B" uniqKey="Belshe R" first="Robert B." last="Belshe">Robert B. Belshe</name><affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="ISSN">0264-410X</idno><idno type="eISSN">1873-2518</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">During the 2009 influenza pandemic both seasonal and 2009 pandemic vaccines were recommended. We conducted a randomized trial of monovalent 2009-H1N1 vaccine and seasonal trivalent inactivated influenza vaccine (IIV3) given sequentially or concurrently to adults.</p></sec><sec id="S2"><title>Methods</title><p id="P2">Adults randomized to 4 study groups and stratified by age (18-64 and ≥65 years) received 1 dose of seasonal IIV3 or placebo and 2 doses of 2009-H1N1 vaccine or placebo in one of 4 combinations, i.e., H1N1+Placebo/H1N1+Placebo/<bold>II<italic>V</italic>3</bold> (HP/HP/<bold>V3</bold>), H1N1+ <bold>IIV3</bold>/H1N1+Placebo/Placebo (H<bold>V3</bold>/HP/P), H1N1+Placebo/H1N1+ <bold>IIV3</bold>/Placebo (HP/H<bold>V3</bold>/P), and II<bold>V3</bold>+Placebo/H1N1+Placebo/H1N1 (<bold>V3</bold>P/HP/H). Intramuscular injections were given three times at 21 day intervals. Sera for antibody assays were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored.</p></sec><sec id="S3"><title>Results</title><p id="P3">Eight hundred-five (805) adults were enrolled. All combinations of vaccines were safe and well tolerated. In general, one dose of 2009-H1N1 and one dose of IIV3, regardless of sequence or concurrency of administration, were immunogenic in adults. There were no significant differences in geometric mean titers (GMT) or the proportions of subjects with ≥4-fold rise in antibody responses and titers ≥40 for any vaccine group or between age strata for 2009-H1N1 after the first or second dose, although the vaccine sequence affected the titers to the IIV3 antigens. Hemagglutination inhibition antibody (HAI) GMTs against 2009-H1N1 for the combined age strata 21 days after the first 2009-H1N1 dose were 190.4, 182.1, 232.9 and 157.5 for HP/HP/<bold>V3</bold>, H<bold>V3</bold>/HP/P, HP/H<bold>V3</bold>/P and <bold>V3</bold>P/HP/H, respectively. While IIV3 GMTs were adequate they were generally lower than the 2009-H1N1 GMTs. In a subset of subjects, there was good correlation between HAI and microneutralization (MN) titers (Spearman's correlation coefficient 0.92).</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">All vaccine combinations were generally well tolerated. Immune responses to one dose of 2009-H1N1 were adequate regardless of the sequence of vaccination in all age groups, but the sequence affected titers to IIV3 antigens.</p></sec></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>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">8406899</journal-id><journal-id journal-id-type="pubmed-jr-id">7945</journal-id><journal-id journal-id-type="nlm-ta">Vaccine</journal-id><journal-id journal-id-type="iso-abbrev">Vaccine</journal-id><journal-title-group><journal-title>Vaccine</journal-title></journal-title-group><issn pub-type="ppub">0264-410X</issn><issn pub-type="epub">1873-2518</issn></journal-meta><article-meta><article-id pub-id-type="pmid">25444805</article-id><article-id pub-id-type="pmc">4293632</article-id><article-id pub-id-type="doi">10.1016/j.vaccine.2014.10.083</article-id><article-id pub-id-type="manuscript">NIHMS643314</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Frey</surname><given-names>Sharon E.</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Bernstein</surname><given-names>David I.</given-names></name><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Brady</surname><given-names>Rebecca C.</given-names></name><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Keitel</surname><given-names>Wendy A.</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Sahly</surname><given-names>Hana El</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Rouphael</surname><given-names>Nadine Georges</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Mulligan</surname><given-names>Mark J.</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Atmar</surname><given-names>Robert L.</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Edupuganti</surname><given-names>Srilatha</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Patel</surname><given-names>Shital M.</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Dickey</surname><given-names>Michelle</given-names></name><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Graham</surname><given-names>Irene</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Anderson</surname><given-names>Edwin L.</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Noah</surname><given-names>Diana L.</given-names></name><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Hill</surname><given-names>Heather</given-names></name><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Wolff</surname><given-names>Mark</given-names></name><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Belshe</surname><given-names>Robert B.</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib></contrib-group><aff id="A1"><label>1</label>Saint Louis University School of Medicine</aff><aff id="A2"><label>2</label>Cincinnati Children's Hospital Medical Center, University of Cincinnati</aff><aff id="A3"><label>3</label>Baylor College of Medicine</aff><aff id="A4"><label>4</label>The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine</aff><aff id="A5"><label>5</label>Southern Research Institute</aff><aff id="A6"><label>6</label>The EMMES Corporation</aff><author-notes><corresp id="FN1">Corresponding Author: Sharon E. Frey, MD, Professor, Division of Infectious Diseases, Allergy & Immunology, Saint Louis University School of Medicine, Vaccine Treatment and Evaluation Unit, 1100 S. Grand Blvd., DRC-8th Floor, St. Louis, MO 63104, Phone: 314-977-5500, Fax: 314-771-3816, <email>freyse@slu.edu</email></corresp><fn id="FN2" fn-type="conflict"><p>Sharon Frey, David Bernstein, Wendy Keitel, Hana El Sahly, Rebecca Brady, Nadine Georges Rouphael, Mark J. Mulligan, Heather Hill, Mark Wolff, Diana Noah, Robert Belshe, Robert L. Atmar, Srilatha Edupuganti, Shital M. Patel, Irene Graham and Edwin Anderson have no conflicts of interest to declare.</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>12</day><month>12</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>11</day><month>11</month><year>2014</year></pub-date><pub-date pub-type="ppub"><day>1</day><month>1</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>1</month><year>2016</year></pub-date><volume>33</volume><issue>1</issue><fpage>163</fpage><lpage>173</lpage><pmc-comment>elocation-id from pubmed: 10.1016/j.vaccine.2014.10.083</pmc-comment>
<permissions><copyright-statement>© 2014 Elsevier Ltd. All rights reserved.</copyright-statement><copyright-year>2014</copyright-year></permissions><abstract><sec id="S1"><title>Background</title><p id="P1">During the 2009 influenza pandemic both seasonal and 2009 pandemic vaccines were recommended. We conducted a randomized trial of monovalent 2009-H1N1 vaccine and seasonal trivalent inactivated influenza vaccine (IIV3) given sequentially or concurrently to adults.</p></sec><sec id="S2"><title>Methods</title><p id="P2">Adults randomized to 4 study groups and stratified by age (18-64 and ≥65 years) received 1 dose of seasonal IIV3 or placebo and 2 doses of 2009-H1N1 vaccine or placebo in one of 4 combinations, i.e., H1N1+Placebo/H1N1+Placebo/<bold>II<italic>V</italic>3</bold> (HP/HP/<bold>V3</bold>), H1N1+ <bold>IIV3</bold>/H1N1+Placebo/Placebo (H<bold>V3</bold>/HP/P), H1N1+Placebo/H1N1+ <bold>IIV3</bold>/Placebo (HP/H<bold>V3</bold>/P), and II<bold>V3</bold>+Placebo/H1N1+Placebo/H1N1 (<bold>V3</bold>P/HP/H). Intramuscular injections were given three times at 21 day intervals. Sera for antibody assays were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored.</p></sec><sec id="S3"><title>Results</title><p id="P3">Eight hundred-five (805) adults were enrolled. All combinations of vaccines were safe and well tolerated. In general, one dose of 2009-H1N1 and one dose of IIV3, regardless of sequence or concurrency of administration, were immunogenic in adults. There were no significant differences in geometric mean titers (GMT) or the proportions of subjects with ≥4-fold rise in antibody responses and titers ≥40 for any vaccine group or between age strata for 2009-H1N1 after the first or second dose, although the vaccine sequence affected the titers to the IIV3 antigens. Hemagglutination inhibition antibody (HAI) GMTs against 2009-H1N1 for the combined age strata 21 days after the first 2009-H1N1 dose were 190.4, 182.1, 232.9 and 157.5 for HP/HP/<bold>V3</bold>, H<bold>V3</bold>/HP/P, HP/H<bold>V3</bold>/P and <bold>V3</bold>P/HP/H, respectively. While IIV3 GMTs were adequate they were generally lower than the 2009-H1N1 GMTs. In a subset of subjects, there was good correlation between HAI and microneutralization (MN) titers (Spearman's correlation coefficient 0.92).</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">All vaccine combinations were generally well tolerated. Immune responses to one dose of 2009-H1N1 were adequate regardless of the sequence of vaccination in all age groups, but the sequence affected titers to IIV3 antigens.</p></sec></abstract><kwd-group><kwd>Influenza vaccine</kwd><kwd>2009-H1N1</kwd><kwd>seasonal IIV3</kwd><kwd>pandemic</kwd><kwd>adults</kwd><kwd>elderly</kwd><kwd>concurrent</kwd><kwd>sequential</kwd><kwd>HAI</kwd><kwd>microneutralization</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Curation/RBID.i -Sk "pubmed:25444805" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd \
| NlmPubMed2Wicri -a PandemieGrippaleV1
| This area was generated with Dilib version V0.6.34. |  |