PandemieGrippaleV1, PubMed, Curation, bibRecord, 000734

Phase II trial in adults of concurrent or sequential 2009 pandemic H1N1 and 2009-2010 seasonal trivalent influenza vaccinations.

Identifieur interne : 000734 ( PubMed/Curation ); précédent : 000733; suivant : 000735

Phase II trial in adults of concurrent or sequential 2009 pandemic H1N1 and 2009-2010 seasonal trivalent influenza vaccinations.

Auteurs : Sharon E. Frey [États-Unis] ; David I. Bernstein [États-Unis] ; Rebecca C. Brady [États-Unis] ; Wendy A. Keitel [États-Unis] ; Hana El Sahly [États-Unis] ; Nadine Georges Rouphael [États-Unis] ; Mark J. Mulligan [États-Unis] ; Robert L. Atmar [États-Unis] ; Srilatha Edupuganti [États-Unis] ; Shital M. Patel [États-Unis] ; Michelle Dickey [États-Unis] ; Irene Graham [États-Unis] ; Edwin L. Anderson [États-Unis] ; Diana L. Noah [États-Unis] ; Heather Hill [États-Unis] ; Mark Wolff [États-Unis] ; Robert B. Belshe [États-Unis]

Source :

Vaccine [ 1873-2518 ] ; 2015.

RBID : pubmed:25444805

Descripteurs français

KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Calendrier vaccinal, Femelle, Grippe humaine (), Humains, Injections musculaires, Jeune adulte, Mâle, Placebo (administration et posologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Vaccination (), Vaccination (effets indésirables), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie).
MESH :
- administration et posologie : Placebo, Vaccins antigrippaux.
- effets indésirables : Vaccination, Vaccins antigrippaux.
- immunologie : Vaccins antigrippaux.
- sang : Anticorps antiviraux.
- Adolescent, Adulte, Adulte d'âge moyen, Calendrier vaccinal, Femelle, Grippe humaine, Humains, Injections musculaires, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Vaccination.

English descriptors

KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Viral (blood), Female, Hemagglutination Inhibition Tests, Humans, Immunization Schedule, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Injections, Intramuscular, Male, Middle Aged, Placebos (administration & dosage), Vaccination (adverse effects), Vaccination (methods), Young Adult.
MESH :
- chemical , administration & dosage : Influenza Vaccines, Placebos.
- chemical , adverse effects : Influenza Vaccines.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Influenza Vaccines.
- adverse effects : Vaccination.
- methods : Vaccination.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Hemagglutination Inhibition Tests, Humans, Immunization Schedule, Injections, Intramuscular, Male, Middle Aged, Young Adult.

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.

DOI: 10.1016/j.vaccine.2014.10.083
PubMed: 25444805

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Le document en format XML

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<front><div type="abstract" xml:lang="en">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.</div>
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<Title>Vaccine</Title>
<ISOAbbreviation>Vaccine</ISOAbbreviation>
</Journal>
<ArticleTitle>Phase II trial in adults of concurrent or sequential 2009 pandemic H1N1 and 2009-2010 seasonal trivalent influenza vaccinations.</ArticleTitle>
<Pagination><MedlinePgn>163-73</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2014.10.083</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0264-410X(14)01502-3</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">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.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">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/IIV3 (HP/HP/V3), H1N1+IIV3/H1N1+Placebo/Placebo (HV3/HP/P), H1N1+Placebo/H1N1+IIV3/Placebo (HP/HV3/P), and IIV3+Placebo/H1N1+Placebo/H1N1 (V3P/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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">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/V3, HV3/HP/P, HP/HV3/P and V3P/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).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">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.</AbstractText>
<CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Frey</LastName>
<ForeName>Sharon E</ForeName>
<Initials>SE</Initials>
<AffiliationInfo><Affiliation>Saint Louis University School of Medicine, United States. Electronic address: freyse@slu.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bernstein</LastName>
<ForeName>David I</ForeName>
<Initials>DI</Initials>
<AffiliationInfo><Affiliation>Cincinnati Children's Hospital Medical Center, University of Cincinnati, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Brady</LastName>
<ForeName>Rebecca C</ForeName>
<Initials>RC</Initials>
<AffiliationInfo><Affiliation>Cincinnati Children's Hospital Medical Center, University of Cincinnati, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Keitel</LastName>
<ForeName>Wendy A</ForeName>
<Initials>WA</Initials>
<AffiliationInfo><Affiliation>Baylor College of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>El Sahly</LastName>
<ForeName>Hana</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Baylor College of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rouphael</LastName>
<ForeName>Nadine Georges</ForeName>
<Initials>NG</Initials>
<AffiliationInfo><Affiliation>The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mulligan</LastName>
<ForeName>Mark J</ForeName>
<Initials>MJ</Initials>
<AffiliationInfo><Affiliation>The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Atmar</LastName>
<ForeName>Robert L</ForeName>
<Initials>RL</Initials>
<AffiliationInfo><Affiliation>Baylor College of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Edupuganti</LastName>
<ForeName>Srilatha</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Patel</LastName>
<ForeName>Shital M</ForeName>
<Initials>SM</Initials>
<AffiliationInfo><Affiliation>Baylor College of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dickey</LastName>
<ForeName>Michelle</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Cincinnati Children's Hospital Medical Center, University of Cincinnati, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Graham</LastName>
<ForeName>Irene</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Saint Louis University School of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Anderson</LastName>
<ForeName>Edwin L</ForeName>
<Initials>EL</Initials>
<AffiliationInfo><Affiliation>Saint Louis University School of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Noah</LastName>
<ForeName>Diana L</ForeName>
<Initials>DL</Initials>
<AffiliationInfo><Affiliation>Southern Research Institute, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hill</LastName>
<ForeName>Heather</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>The EMMES Corporation, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wolff</LastName>
<ForeName>Mark</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>The EMMES Corporation, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Belshe</LastName>
<ForeName>Robert B</ForeName>
<Initials>RB</Initials>
<AffiliationInfo><Affiliation>Saint Louis University School of Medicine, United States.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<GrantList CompleteYN="Y"><Grant><GrantID>HHSN272200800006C</GrantID>
<Acronym>AI</Acronym>
<Agency>NIAID NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800006C</GrantID>
<Agency>PHS HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800002C</GrantID>
<Acronym>AI</Acronym>
<Agency>NIAID NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800002C</GrantID>
<Agency>PHS HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800013C</GrantID>
<Acronym>AI</Acronym>
<Agency>NIAID NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800005C</GrantID>
<Acronym>AI</Acronym>
<Agency>NIAID NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800003C</GrantID>
<Agency>PHS HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800003C</GrantID>
<Acronym>AI</Acronym>
<Agency>NIAID NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>N01AI30063</GrantID>
<Acronym>AI</Acronym>
<Agency>NIAID NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800005C</GrantID>
<Agency>PHS HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>HHSN272200800013C</GrantID>
<Agency>PHS HHS</Agency>
<Country>United States</Country>
</Grant>
</GrantList>
<PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</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>2014</Year>
<Month>11</Month>
<Day>11</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="D000914">Antibodies, Viral</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D010919">Placebos</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</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="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="D007115" MajorTopicYN="Y">Immunization Schedule</DescriptorName>
</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="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007273" MajorTopicYN="N">Injections, Intramuscular</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">2009-H1N1</Keyword>
<Keyword MajorTopicYN="N">Adults</Keyword>
<Keyword MajorTopicYN="N">Concurrent</Keyword>
<Keyword MajorTopicYN="N">Elderly</Keyword>
<Keyword MajorTopicYN="N">HAI</Keyword>
<Keyword MajorTopicYN="N">Influenza vaccine</Keyword>
<Keyword MajorTopicYN="N">Microneutralization</Keyword>
<Keyword MajorTopicYN="N">Pandemic</Keyword>
<Keyword MajorTopicYN="N">Seasonal IIV3</Keyword>
<Keyword MajorTopicYN="N">Sequential</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year>
<Month>06</Month>
<Day>30</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2014</Year>
<Month>10</Month>
<Day>14</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2014</Year>
<Month>10</Month>
<Day>30</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2014</Year>
<Month>12</Month>
<Day>3</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2014</Year>
<Month>12</Month>
<Day>3</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2015</Year>
<Month>7</Month>
<Day>22</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
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<ArticleId IdType="pmc">PMC4293632</ArticleId>
<ArticleId IdType="mid">NIHMS643314</ArticleId>
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Phase II trial in adults of concurrent or sequential 2009 pandemic H1N1 and 2009-2010 seasonal trivalent influenza vaccinations.

Phase II trial in adults of concurrent or sequential 2009 pandemic H1N1 and 2009-2010 seasonal trivalent influenza vaccinations.

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