Meta-Analysis and Potential Role of Preexisting Heterosubtypic Cellular Immunity Based on Variations in Disease Severity Outcomes for Influenza Live Viral Challenges in Humans.
Identifieur interne : 000642 ( PubMed/Curation ); précédent : 000641; suivant : 000643Meta-Analysis and Potential Role of Preexisting Heterosubtypic Cellular Immunity Based on Variations in Disease Severity Outcomes for Influenza Live Viral Challenges in Humans.
Auteurs : Olga Pleguezuelos [Royaume-Uni] ; Stuart Robinson [Royaume-Uni] ; Ana Fernandez [Royaume-Uni] ; Gregory A. Stoloff [Royaume-Uni] ; Wilson Caparr S-Wanderley [Oman]Source :
- Clinical and vaccine immunology : CVI [ 1556-679X ] ; 2015.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Agranulocytes (immunologie), Excrétion virale, Femelle, Grippe humaine (anatomopathologie), Grippe humaine (immunologie), Humains, Immunité cellulaire, Indice de gravité médicale, Interféron gamma (métabolisme), Jeune adulte, Mâle, Placebo (administration et posologie), Résultat thérapeutique, Études cliniques comme sujet.
- MESH :
- administration et posologie : Placebo.
- anatomopathologie : Grippe humaine.
- immunologie : Agranulocytes, Grippe humaine.
- métabolisme : Interféron gamma.
- Adolescent, Adulte, Adulte d'âge moyen, Excrétion virale, Femelle, Humains, Immunité cellulaire, Indice de gravité médicale, Jeune adulte, Mâle, Résultat thérapeutique, Études cliniques comme sujet.
English descriptors
- KwdEn :
- Adolescent, Adult, Clinical Studies as Topic, Female, Humans, Immunity, Cellular, Influenza, Human (immunology), Influenza, Human (pathology), Interferon-gamma (metabolism), Leukocytes, Mononuclear (immunology), Male, Middle Aged, Placebos (administration & dosage), Severity of Illness Index, Treatment Outcome, Virus Shedding, Young Adult.
- MESH :
- chemical , administration & dosage : Placebos.
- chemical , metabolism : Interferon-gamma.
- immunology : Influenza, Human, Leukocytes, Mononuclear.
- pathology : Influenza, Human.
- Adolescent, Adult, Clinical Studies as Topic, Female, Humans, Immunity, Cellular, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Virus Shedding, Young Adult.
Abstract
Influenza live viral challenges in humans are valuable models for testing the efficacy of vaccines and antiviral agents. Volunteers are treated with an investigational agent, and their clinical outcomes postchallenge are compared to those of placebo-treated volunteers. Despite using a common protocol, similar recruitment criteria, and similar doses of the same challenge strain, we noticed differences in disease severity outcomes between the placebo groups from different studies. We investigated whether these differences were significant and, if so, whether any pattern and its possible causes could be identified. We compared the clinical outcomes postchallenge in placebo groups from five clinical studies carried out between 2008 and 2013. Correlations between the prechallenge heterosubtypic cellular response (gamma interferon [IFN-γ]) and postchallenge clinical outcomes were also investigated in one study. Placebo groups from studies carried out between 2009 and 2010 attained significantly reduced (P < 0.05) symptom scores postchallenge compared to those of placebo groups from studies carried out in either 2008 or 2013. Also, in a 2010 study, the frequency of high-influenza heterosubtypic cellular responders prevaccination was significantly lower in the test group (FLU-v) than that in the placebo group (P = 0.04). Moreover, the increased preexisting heterosubtypic cellular response of the placebo group correlated with reductions in symptom score and viral shedding postchallenge (P ≤ 0.023). Only postvaccination did the test group display an equivalent correlation. The last influenza pandemic coincided with a significant reduction in disease severity outcomes. This reduction also appears to correlate with increased preexisting influenza heterosubtypic cellular responses. (This study is registered at ClinicalTrials.gov under registration number NCT01226758.).
DOI: 10.1128/CVI.00101-15
PubMed: 26084515
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Stoloff</name><affiliation wicri:level="1"><nlm:affiliation>SEEK, Central Point, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>SEEK, Central Point, London</wicri:regionArea></affiliation></author><author><name sortKey="Caparr S Wanderley, Wilson" sort="Caparr S Wanderley, Wilson" uniqKey="Caparr S Wanderley W" first="Wilson" last="Caparr S-Wanderley">Wilson Caparr S-Wanderley</name><affiliation wicri:level="1"><nlm:affiliation>SEEK, Central Point, London, United Kingdom wilson.wanderley@seekacure.com.</nlm:affiliation><country wicri:rule="url">Oman</country><wicri:regionArea>SEEK, Central Point, London</wicri:regionArea></affiliation></author></analytic><series><title level="j">Clinical and vaccine immunology : CVI</title><idno type="eISSN">1556-679X</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Clinical Studies as Topic</term><term>Female</term><term>Humans</term><term>Immunity, Cellular</term><term>Influenza, Human (immunology)</term><term>Influenza, Human (pathology)</term><term>Interferon-gamma (metabolism)</term><term>Leukocytes, Mononuclear (immunology)</term><term>Male</term><term>Middle Aged</term><term>Placebos (administration & dosage)</term><term>Severity of Illness Index</term><term>Treatment Outcome</term><term>Virus Shedding</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Agranulocytes (immunologie)</term><term>Excrétion virale</term><term>Femelle</term><term>Grippe humaine (anatomopathologie)</term><term>Grippe humaine (immunologie)</term><term>Humains</term><term>Immunité cellulaire</term><term>Indice de gravité médicale</term><term>Interféron gamma (métabolisme)</term><term>Jeune adulte</term><term>Mâle</term><term>Placebo (administration et posologie)</term><term>Résultat thérapeutique</term><term>Études cliniques comme sujet</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Placebos</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Interferon-gamma</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Placebo</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Grippe humaine</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Agranulocytes</term><term>Grippe humaine</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza, Human</term><term>Leukocytes, Mononuclear</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Interféron gamma</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Clinical Studies as Topic</term><term>Female</term><term>Humans</term><term>Immunity, Cellular</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term><term>Treatment Outcome</term><term>Virus Shedding</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Excrétion virale</term><term>Femelle</term><term>Humains</term><term>Immunité cellulaire</term><term>Indice de gravité médicale</term><term>Jeune adulte</term><term>Mâle</term><term>Résultat thérapeutique</term><term>Études cliniques comme sujet</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Influenza live viral challenges in humans are valuable models for testing the efficacy of vaccines and antiviral agents. Volunteers are treated with an investigational agent, and their clinical outcomes postchallenge are compared to those of placebo-treated volunteers. Despite using a common protocol, similar recruitment criteria, and similar doses of the same challenge strain, we noticed differences in disease severity outcomes between the placebo groups from different studies. We investigated whether these differences were significant and, if so, whether any pattern and its possible causes could be identified. We compared the clinical outcomes postchallenge in placebo groups from five clinical studies carried out between 2008 and 2013. Correlations between the prechallenge heterosubtypic cellular response (gamma interferon [IFN-γ]) and postchallenge clinical outcomes were also investigated in one study. Placebo groups from studies carried out between 2009 and 2010 attained significantly reduced (P < 0.05) symptom scores postchallenge compared to those of placebo groups from studies carried out in either 2008 or 2013. Also, in a 2010 study, the frequency of high-influenza heterosubtypic cellular responders prevaccination was significantly lower in the test group (FLU-v) than that in the placebo group (P = 0.04). Moreover, the increased preexisting heterosubtypic cellular response of the placebo group correlated with reductions in symptom score and viral shedding postchallenge (P ≤ 0.023). Only postvaccination did the test group display an equivalent correlation. The last influenza pandemic coincided with a significant reduction in disease severity outcomes. This reduction also appears to correlate with increased preexisting influenza heterosubtypic cellular responses. (This study is registered at ClinicalTrials.gov under registration number NCT01226758.). </div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26084515</PMID><DateCompleted><Year>2016</Year><Month>04</Month><Day>21</Day></DateCompleted><DateRevised><Year>2018</Year><Month>12</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1556-679X</ISSN><JournalIssue CitedMedium="Internet"><Volume>22</Volume><Issue>8</Issue><PubDate><Year>2015</Year><Month>Aug</Month></PubDate></JournalIssue><Title>Clinical and vaccine immunology : CVI</Title><ISOAbbreviation>Clin. Vaccine Immunol.</ISOAbbreviation></Journal><ArticleTitle>Meta-Analysis and Potential Role of Preexisting Heterosubtypic Cellular Immunity Based on Variations in Disease Severity Outcomes for Influenza Live Viral Challenges in Humans.</ArticleTitle><Pagination><MedlinePgn>949-56</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1128/CVI.00101-15</ELocationID><Abstract><AbstractText>Influenza live viral challenges in humans are valuable models for testing the efficacy of vaccines and antiviral agents. Volunteers are treated with an investigational agent, and their clinical outcomes postchallenge are compared to those of placebo-treated volunteers. Despite using a common protocol, similar recruitment criteria, and similar doses of the same challenge strain, we noticed differences in disease severity outcomes between the placebo groups from different studies. We investigated whether these differences were significant and, if so, whether any pattern and its possible causes could be identified. We compared the clinical outcomes postchallenge in placebo groups from five clinical studies carried out between 2008 and 2013. Correlations between the prechallenge heterosubtypic cellular response (gamma interferon [IFN-γ]) and postchallenge clinical outcomes were also investigated in one study. Placebo groups from studies carried out between 2009 and 2010 attained significantly reduced (P < 0.05) symptom scores postchallenge compared to those of placebo groups from studies carried out in either 2008 or 2013. Also, in a 2010 study, the frequency of high-influenza heterosubtypic cellular responders prevaccination was significantly lower in the test group (FLU-v) than that in the placebo group (P = 0.04). Moreover, the increased preexisting heterosubtypic cellular response of the placebo group correlated with reductions in symptom score and viral shedding postchallenge (P ≤ 0.023). Only postvaccination did the test group display an equivalent correlation. The last influenza pandemic coincided with a significant reduction in disease severity outcomes. This reduction also appears to correlate with increased preexisting influenza heterosubtypic cellular responses. (This study is registered at ClinicalTrials.gov under registration number NCT01226758.). </AbstractText><CopyrightInformation>Copyright © 2015, American Society for Microbiology. All Rights Reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pleguezuelos</LastName><ForeName>Olga</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>SEEK, Central Point, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robinson</LastName><ForeName>Stuart</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>SEEK, Central Point, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fernandez</LastName><ForeName>Ana</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>SEEK, Central Point, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stoloff</LastName><ForeName>Gregory A</ForeName><Initials>GA</Initials><AffiliationInfo><Affiliation>SEEK, Central Point, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Caparrós-Wanderley</LastName><ForeName>Wilson</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>SEEK, Central Point, London, United Kingdom wilson.wanderley@seekacure.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01226758</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D017418">Meta-Analysis</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>06</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Vaccine Immunol</MedlineTA><NlmUniqueID>101252125</NlmUniqueID><ISSNLinking>1556-679X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical><Chemical><RegistryNumber>82115-62-6</RegistryNumber><NameOfSubstance UI="D007371">Interferon-gamma</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="D000068456" MajorTopicYN="N">Clinical Studies as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007111" MajorTopicYN="Y">Immunity, Cellular</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007371" MajorTopicYN="N">Interferon-gamma</DescriptorName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007963" MajorTopicYN="N">Leukocytes, Mononuclear</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></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="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012720" MajorTopicYN="Y">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017201" MajorTopicYN="N">Virus Shedding</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>02</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>06</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>6</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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