Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response: A Randomized Clinical Trial.
Identifieur interne : 000629 ( PubMed/Corpus ); précédent : 000628; suivant : 000630Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response: A Randomized Clinical Trial.
Auteurs : Lisa A. Jackson ; James D. Campbell ; Sharon E. Frey ; Kathryn M. Edwards ; Wendy A. Keitel ; Karen L. Kotloff ; Andrea A. Berry ; Irene Graham ; Robert L. Atmar ; C Buddy Creech ; Isaac P. Thomsen ; Shital M. Patel ; Andres F. Gutierrez ; Edwin L. Anderson ; Hana M. El Sahly ; Heather Hill ; Diana L. Noah ; Abbie R. BellamySource :
- JAMA [ 1538-3598 ] ; 2015.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adult, Age Factors, Antibodies, Viral (blood), Double-Blind Method, Drug Combinations, Female, Hemagglutination Inhibition Tests, Hemagglutination, Viral (immunology), Humans, Influenza A Virus, H7N9 Subtype, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (immunology), Influenza, Human (prevention & control), Male, Middle Aged, Polysorbates (administration & dosage), Squalene (administration & dosage), alpha-Tocopherol (administration & dosage).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene, alpha-Tocopherol.
- chemical , adverse effects : Influenza Vaccines.
- chemical , blood : Antibodies, Viral.
- immunology : Hemagglutination, Viral, Influenza Vaccines, Influenza, Human.
- prevention & control : Influenza, Human.
- Adult, Age Factors, Double-Blind Method, Drug Combinations, Female, Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H7N9 Subtype, Male, Middle Aged.
Abstract
Human infections with the avian influenza A(H7N9) virus were first reported in China in 2013 and continue to occur. Hemagglutinin H7 administered alone is a poor immunogen necessitating evaluation of adjuvanted H7N9 vaccines.
DOI: 10.1001/jama.2015.7916
PubMed: 26197184
Links to Exploration step
pubmed:26197184Le document en format XML
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Frey</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</nlm:affiliation></affiliation></author><author><name sortKey="Edwards, Kathryn M" sort="Edwards, Kathryn M" uniqKey="Edwards K" first="Kathryn M" last="Edwards">Kathryn M. Edwards</name><affiliation><nlm:affiliation>Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation></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:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L" last="Kotloff">Karen L. Kotloff</name><affiliation><nlm:affiliation>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.</nlm:affiliation></affiliation></author><author><name sortKey="Berry, Andrea A" sort="Berry, Andrea A" uniqKey="Berry A" first="Andrea A" last="Berry">Andrea A. 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Patel</name><affiliation><nlm:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Gutierrez, Andres F" sort="Gutierrez, Andres F" uniqKey="Gutierrez A" first="Andres F" last="Gutierrez">Andres F. Gutierrez</name><affiliation><nlm:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></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:affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</nlm:affiliation></affiliation></author><author><name sortKey="El Sahly, Hana M" sort="El Sahly, Hana M" uniqKey="El Sahly H" first="Hana M" last="El Sahly">Hana M. El Sahly</name><affiliation><nlm:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation><nlm:affiliation>The EMMES Corporation, Rockville, Maryland.</nlm:affiliation></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:affiliation>Southern Research Institute, Birmingham, Alabama.</nlm:affiliation></affiliation></author><author><name sortKey="Bellamy, Abbie R" sort="Bellamy, Abbie R" uniqKey="Bellamy A" first="Abbie R" last="Bellamy">Abbie R. Bellamy</name><affiliation><nlm:affiliation>The EMMES Corporation, Rockville, Maryland.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26197184</idno><idno type="pmid">26197184</idno><idno type="doi">10.1001/jama.2015.7916</idno><idno type="wicri:Area/PubMed/Corpus">000629</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000629</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response: A Randomized Clinical Trial.</title><author><name sortKey="Jackson, Lisa A" sort="Jackson, Lisa A" uniqKey="Jackson L" first="Lisa A" last="Jackson">Lisa A. Jackson</name><affiliation><nlm:affiliation>Group Health Research Institute, Seattle, Washington.</nlm:affiliation></affiliation></author><author><name sortKey="Campbell, James D" sort="Campbell, James D" uniqKey="Campbell J" first="James D" last="Campbell">James D. Campbell</name><affiliation><nlm:affiliation>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.</nlm:affiliation></affiliation></author><author><name sortKey="Frey, Sharon E" sort="Frey, Sharon E" uniqKey="Frey S" first="Sharon E" last="Frey">Sharon E. Frey</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</nlm:affiliation></affiliation></author><author><name sortKey="Edwards, Kathryn M" sort="Edwards, Kathryn M" uniqKey="Edwards K" first="Kathryn M" last="Edwards">Kathryn M. Edwards</name><affiliation><nlm:affiliation>Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation></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:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Kotloff, Karen L" sort="Kotloff, Karen L" uniqKey="Kotloff K" first="Karen L" last="Kotloff">Karen L. Kotloff</name><affiliation><nlm:affiliation>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.</nlm:affiliation></affiliation></author><author><name sortKey="Berry, Andrea A" sort="Berry, Andrea A" uniqKey="Berry A" first="Andrea A" last="Berry">Andrea A. Berry</name><affiliation><nlm:affiliation>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.</nlm:affiliation></affiliation></author><author><name sortKey="Graham, Irene" sort="Graham, Irene" uniqKey="Graham I" first="Irene" last="Graham">Irene Graham</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</nlm:affiliation></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:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Creech, C Buddy" sort="Creech, C Buddy" uniqKey="Creech C" first="C Buddy" last="Creech">C Buddy Creech</name><affiliation><nlm:affiliation>Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation></affiliation></author><author><name sortKey="Thomsen, Isaac P" sort="Thomsen, Isaac P" uniqKey="Thomsen I" first="Isaac P" last="Thomsen">Isaac P. Thomsen</name><affiliation><nlm:affiliation>Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation></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:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Gutierrez, Andres F" sort="Gutierrez, Andres F" uniqKey="Gutierrez A" first="Andres F" last="Gutierrez">Andres F. Gutierrez</name><affiliation><nlm:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></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:affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</nlm:affiliation></affiliation></author><author><name sortKey="El Sahly, Hana M" sort="El Sahly, Hana M" uniqKey="El Sahly H" first="Hana M" last="El Sahly">Hana M. El Sahly</name><affiliation><nlm:affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation><nlm:affiliation>The EMMES Corporation, Rockville, Maryland.</nlm:affiliation></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:affiliation>Southern Research Institute, Birmingham, Alabama.</nlm:affiliation></affiliation></author><author><name sortKey="Bellamy, Abbie R" sort="Bellamy, Abbie R" uniqKey="Bellamy A" first="Abbie R" last="Bellamy">Abbie R. Bellamy</name><affiliation><nlm:affiliation>The EMMES Corporation, Rockville, Maryland.</nlm:affiliation></affiliation></author></analytic><series><title level="j">JAMA</title><idno type="eISSN">1538-3598</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Adult</term><term>Age Factors</term><term>Antibodies, Viral (blood)</term><term>Double-Blind Method</term><term>Drug Combinations</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Hemagglutination, Viral (immunology)</term><term>Humans</term><term>Influenza A Virus, H7N9 Subtype</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>Male</term><term>Middle Aged</term><term>Polysorbates (administration & dosage)</term><term>Squalene (administration & dosage)</term><term>alpha-Tocopherol (administration & dosage)</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>alpha-Tocopherol</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</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>Hemagglutination, Viral</term><term>Influenza Vaccines</term><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Age Factors</term><term>Double-Blind Method</term><term>Drug Combinations</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Influenza A Virus, H7N9 Subtype</term><term>Male</term><term>Middle Aged</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Human infections with the avian influenza A(H7N9) virus were first reported in China in 2013 and continue to occur. Hemagglutinin H7 administered alone is a poor immunogen necessitating evaluation of adjuvanted H7N9 vaccines.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26197184</PMID><DateCompleted><Year>2015</Year><Month>10</Month><Day>05</Day></DateCompleted><DateRevised><Year>2016</Year><Month>10</Month><Day>17</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1538-3598</ISSN><JournalIssue CitedMedium="Internet"><Volume>314</Volume><Issue>3</Issue><PubDate><Year>2015</Year><Month>Jul</Month><Day>21</Day></PubDate></JournalIssue><Title>JAMA</Title><ISOAbbreviation>JAMA</ISOAbbreviation></Journal><ArticleTitle>Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response: A Randomized Clinical Trial.</ArticleTitle><Pagination><MedlinePgn>237-46</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1001/jama.2015.7916</ELocationID><Abstract><AbstractText Label="IMPORTANCE" NlmCategory="OBJECTIVE">Human infections with the avian influenza A(H7N9) virus were first reported in China in 2013 and continue to occur. Hemagglutinin H7 administered alone is a poor immunogen necessitating evaluation of adjuvanted H7N9 vaccines.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the immunogenicity and safety of an inactivated H7N9 vaccine with and without AS03 adjuvant, as well as mixed vaccine schedules that included sequential administration of AS03- and MF59-containing formulations and of adjuvanted and unadjuvanted formulations.</AbstractText><AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">Double-blind, phase 2 trial at 5 US sites enrolled 980 adults aged 19 through 64 years from September 2013 through November 2013; safety follow-up was completed in January 2015.</AbstractText><AbstractText Label="INTERVENTIONS" NlmCategory="METHODS">The H7N9 vaccine was given on days 0 and 21 at nominal doses of 3.75 µg, 7.5 µg, 15 µg, and 45 µg of hemagglutinin with or without AS03 or MF59 adjuvant mixed on site.</AbstractText><AbstractText Label="MAIN OUTCOMES AND MEASURES" NlmCategory="METHODS">Proportions achieving a hemagglutination inhibition antibody (HIA) titer of 40 or higher at 21 days after the second vaccination; vaccine-related serious adverse events through 12 months after the first vaccination; and solicited signs and symptoms after vaccination through day 7.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Two doses of vaccine were required to induce detectable antibody titers in most participants. After 2 doses of an H7N9 formulation containing 15 µg of hemagglutinin given without adjuvant, with AS03 adjuvant, or with MF59 adjuvant, the proportion achieving an HIA titer of 40 or higher was 2% (95% CI, 0%-7%) without adjuvant (n = 94), 84% (95% CI, 76%-91%) with AS03 adjuvant (n = 96), and 57% (95% CI, 47%-68%) with MF59 adjuvant (n = 92) (P < .001 for comparison of the AS03 and MF59 schedules). The 2 schedules alternating AS03-and MF59-adjuvanted formulations led to lower geometric mean titers (GMTs) of (41.5 [95% CI, 31.7-54.4]; n = 92) and (58.6 [95% CI, 44.3-77.6]; n = 96) than the group induced by 2 AS03-adjuvanted formulations (n = 96) (103.4 [95% CI, 78.7-135.9]; P < .001) but higher GMTs than 2 doses of MF59-adjuvanted formulation (n = 94) (29.0 [95% CI, 22.4-37.6]; P < .001).</AbstractText><AbstractText Label="CONCLUSIONS AND RELEVANCE" NlmCategory="CONCLUSIONS">The AS03 and MF59 adjuvants augmented the immune responses to 2 doses of an inactivated H7N9 influenza vaccine, with AS03-adjuvanted formulations inducing the highest titers. This study of 2 adjuvants used in influenza vaccine formulations with adjuvant mixed on site provides immunogenicity information that may be informative to influenza pandemic preparedness programs.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">clinicaltrials.gov Identifier: NCT01942265.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jackson</LastName><ForeName>Lisa A</ForeName><Initials>LA</Initials><AffiliationInfo><Affiliation>Group Health Research Institute, Seattle, Washington.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campbell</LastName><ForeName>James D</ForeName><Initials>JD</Initials><AffiliationInfo><Affiliation>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Frey</LastName><ForeName>Sharon E</ForeName><Initials>SE</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Edwards</LastName><ForeName>Kathryn M</ForeName><Initials>KM</Initials><AffiliationInfo><Affiliation>Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Keitel</LastName><ForeName>Wendy A</ForeName><Initials>WA</Initials><AffiliationInfo><Affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kotloff</LastName><ForeName>Karen L</ForeName><Initials>KL</Initials><AffiliationInfo><Affiliation>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Berry</LastName><ForeName>Andrea A</ForeName><Initials>AA</Initials><AffiliationInfo><Affiliation>Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Graham</LastName><ForeName>Irene</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Atmar</LastName><ForeName>Robert L</ForeName><Initials>RL</Initials><AffiliationInfo><Affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Creech</LastName><ForeName>C Buddy</ForeName><Initials>CB</Initials><AffiliationInfo><Affiliation>Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomsen</LastName><ForeName>Isaac P</ForeName><Initials>IP</Initials><AffiliationInfo><Affiliation>Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Shital M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gutierrez</LastName><ForeName>Andres F</ForeName><Initials>AF</Initials><AffiliationInfo><Affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Anderson</LastName><ForeName>Edwin L</ForeName><Initials>EL</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Allergy, and Immunology, Saint Louis University School of Medicine, St Louis, Missouri.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>El Sahly</LastName><ForeName>Hana M</ForeName><Initials>HM</Initials><AffiliationInfo><Affiliation>Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hill</LastName><ForeName>Heather</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>The EMMES Corporation, Rockville, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Noah</LastName><ForeName>Diana L</ForeName><Initials>DL</Initials><AffiliationInfo><Affiliation>Southern Research Institute, Birmingham, Alabama.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bellamy</LastName><ForeName>Abbie R</ForeName><Initials>AR</Initials><AffiliationInfo><Affiliation>The EMMES Corporation, Rockville, Maryland.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01942265</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>HHSN27200003</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>HHSN272200800001C</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>HHSN272200800002C</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>HHSN272200800003C</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>HHSN272200800004C</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>HHSN27220080000C</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>HHSN272200800013C</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>HHSN2722012000031</GrantID><Agency>PHS HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>K12-RR-023250</GrantID><Acronym>RR</Acronym><Agency>NCRR NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>M01-RR-016500</GrantID><Acronym>RR</Acronym><Agency>NCRR NIH 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="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>JAMA</MedlineTA><NlmUniqueID>7501160</NlmUniqueID><ISSNLinking>0098-7484</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="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza 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IdType="pii">2397832</ArticleId><ArticleId IdType="doi">10.1001/jama.2015.7916</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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