Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults.
Identifieur interne : 000092 ( PubMed/Corpus ); précédent : 000091; suivant : 000093Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults.
Auteurs : Gerald Aichinger ; Barbara Grohmann-Izay ; Maikel V W. Van Der Velden ; Sandor Fritsch ; Manuela Koska ; Daniel Portsmouth ; Mary Kate Hart ; Wael El-Amin ; Otfried Kistner ; P Noel BarrettSource :
- Clinical and vaccine immunology : CVI [ 1556-679X ] ; 2015.
English descriptors
- KwdEn :
- Adolescent, Adult, Antibodies, Neutralizing (blood), Antibodies, Viral (blood), Double-Blind Method, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Immunodiffusion, Influenza A Virus, H9N2 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male, Middle Aged, Neutralization Tests, Treatment Outcome, Vaccination (adverse effects), Vaccination (methods), Young Adult.
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- chemical , blood : Antibodies, Neutralizing, Antibodies, Viral.
- adverse effects : Vaccination.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : Influenza A Virus, H9N2 Subtype, Influenza Vaccines.
- methods : Vaccination.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Double-Blind Method, Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Immunodiffusion, Male, Middle Aged, Neutralization Tests, Treatment Outcome, Young Adult.
Abstract
Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.).
DOI: 10.1128/CVI.00275-14
PubMed: 25355797
Links to Exploration step
pubmed:25355797Le document en format XML
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Van Der Velden</name><affiliation><nlm:affiliation>Vaccine R&D, Baxter BioScience, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Fritsch, Sandor" sort="Fritsch, Sandor" uniqKey="Fritsch S" first="Sandor" last="Fritsch">Sandor Fritsch</name><affiliation><nlm:affiliation>Global R&D, Baxter BioScience, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Koska, Manuela" sort="Koska, Manuela" uniqKey="Koska M" first="Manuela" last="Koska">Manuela Koska</name><affiliation><nlm:affiliation>Global R&D, Baxter BioScience, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Portsmouth, Daniel" sort="Portsmouth, Daniel" uniqKey="Portsmouth D" first="Daniel" last="Portsmouth">Daniel Portsmouth</name><affiliation><nlm:affiliation>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Hart, Mary Kate" sort="Hart, Mary Kate" uniqKey="Hart M" first="Mary Kate" last="Hart">Mary Kate Hart</name><affiliation><nlm:affiliation>DynPort Vaccine Company, Frederick, Maryland, USA.</nlm:affiliation></affiliation></author><author><name sortKey="El Amin, Wael" sort="El Amin, Wael" uniqKey="El Amin W" first="Wael" last="El-Amin">Wael El-Amin</name><affiliation><nlm:affiliation>DynPort Vaccine Company, Frederick, Maryland, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kistner, Otfried" sort="Kistner, Otfried" uniqKey="Kistner O" first="Otfried" last="Kistner">Otfried Kistner</name><affiliation><nlm:affiliation>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Barrett, P Noel" sort="Barrett, P Noel" uniqKey="Barrett P" first="P Noel" last="Barrett">P Noel Barrett</name><affiliation><nlm:affiliation>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.</nlm:affiliation></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>Antibodies, Neutralizing (blood)</term><term>Antibodies, Viral (blood)</term><term>Double-Blind Method</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Female</term><term>Healthy Volunteers</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Immunodiffusion</term><term>Influenza A Virus, H9N2 Subtype (immunology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (prevention & control)</term><term>Male</term><term>Middle Aged</term><term>Neutralization Tests</term><term>Treatment Outcome</term><term>Vaccination (adverse effects)</term><term>Vaccination (methods)</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</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, Neutralizing</term><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Vaccination</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H9N2 Subtype</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Vaccination</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Double-Blind Method</term><term>Female</term><term>Healthy Volunteers</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Immunodiffusion</term><term>Male</term><term>Middle Aged</term><term>Neutralization Tests</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.). </div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25355797</PMID><DateCompleted><Year>2015</Year><Month>08</Month><Day>27</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1556-679X</ISSN><JournalIssue CitedMedium="Internet"><Volume>22</Volume><Issue>1</Issue><PubDate><Year>2015</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Clinical and vaccine immunology : CVI</Title><ISOAbbreviation>Clin. Vaccine Immunol.</ISOAbbreviation></Journal><ArticleTitle>Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults.</ArticleTitle><Pagination><MedlinePgn>46-55</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1128/CVI.00275-14</ELocationID><Abstract><AbstractText>Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.). </AbstractText><CopyrightInformation>Copyright © 2015, American Society for Microbiology. All Rights Reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Aichinger</LastName><ForeName>Gerald</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Vaccine R&D, Baxter BioScience, Vienna, Austria gerald_aichinger@baxter.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grohmann-Izay</LastName><ForeName>Barbara</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Vaccine R&D, Baxter BioScience, Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van der Velden</LastName><ForeName>Maikel V W</ForeName><Initials>MV</Initials><AffiliationInfo><Affiliation>Vaccine R&D, Baxter BioScience, Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fritsch</LastName><ForeName>Sandor</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Global R&D, Baxter BioScience, Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Koska</LastName><ForeName>Manuela</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Global R&D, Baxter BioScience, Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Portsmouth</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hart</LastName><ForeName>Mary Kate</ForeName><Initials>MK</Initials><AffiliationInfo><Affiliation>DynPort Vaccine Company, Frederick, Maryland, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>El-Amin</LastName><ForeName>Wael</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>DynPort Vaccine Company, Frederick, Maryland, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kistner</LastName><ForeName>Otfried</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barrett</LastName><ForeName>P Noel</ForeName><Initials>PN</Initials><AffiliationInfo><Affiliation>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01320696</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013486">Research Support, U.S. Gov't, Non-P.H.S.</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>10</Month><Day>29</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="D057134">Antibodies, Neutralizing</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</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="D057134" MajorTopicYN="N">Antibodies, Neutralizing</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064368" MajorTopicYN="N">Healthy Volunteers</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="D005779" MajorTopicYN="N">Immunodiffusion</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053127" MajorTopicYN="N">Influenza A Virus, H9N2 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">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="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009500" MajorTopicYN="N">Neutralization Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>10</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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