Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials).
Identifieur interne : 000234 ( PubMed/Corpus ); précédent : 000233; suivant : 000235Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials).
Auteurs : Larisa Rudenko ; Julia Desheva ; Sergey Korovkin ; Alexander Mironov ; Andrey Rekstin ; Elena Grigorieva ; Svetlana Donina ; Alexandra Gambaryan ; Anton KatlinskySource :
- Influenza and other respiratory viruses [ 1750-2659 ] ; 2008.
English descriptors
- KwdEn :
- Administration, Intranasal, Antibodies, Viral (blood), Cross Reactions, Hemagglutination Inhibition Tests, Humans, Immunization, Secondary, Immunoglobulin A (analysis), Influenza A Virus, H2N2 Subtype (genetics), Influenza A Virus, H5N1 Subtype (immunology), Influenza A Virus, H5N2 Subtype (genetics), Influenza A Virus, H5N2 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Nasal Mucosa (immunology), Neutralization Tests, Reassortant Viruses (genetics), Reassortant Viruses (immunology), Russia, Vaccines, Attenuated (administration & dosage), Vaccines, Attenuated (adverse effects), Vaccines, Attenuated (immunology).
- MESH :
- chemical , administration & dosage : Influenza Vaccines, Vaccines, Attenuated.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Attenuated.
- chemical , analysis : Immunoglobulin A.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Vaccines, Attenuated.
- geographic : Russia.
- genetics : Influenza A Virus, H2N2 Subtype, Influenza A Virus, H5N2 Subtype, Reassortant Viruses.
- immunology : Influenza A Virus, H5N1 Subtype, Influenza A Virus, H5N2 Subtype, Influenza Vaccines, Nasal Mucosa, Reassortant Viruses.
- prevention & control : Influenza, Human.
- Administration, Intranasal, Cross Reactions, Hemagglutination Inhibition Tests, Humans, Immunization, Secondary, Neutralization Tests.
Abstract
Our studies aimed to evaluate in clinical trials the safety and immunogenicity of an H5 live influenza vaccine candidate obtained using classical reassortment techniques from a low pathogenicity avian influenza (LPAI) A/Duck/Potsdam/1402-6/86(H5N2) virus and the cold-adapted (ca) donor strain A/Leningrad/134/17/57(H2N2).
DOI: 10.1111/j.1750-2659.2008.00064.x
PubMed: 19453396
Links to Exploration step
pubmed:19453396Le document en format XML
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Pavlov's Street, Saint Petersburg, Russia. vaccine@mail.ru</nlm:affiliation></affiliation></author><author><name sortKey="Desheva, Julia" sort="Desheva, Julia" uniqKey="Desheva J" first="Julia" last="Desheva">Julia Desheva</name></author><author><name sortKey="Korovkin, Sergey" sort="Korovkin, Sergey" uniqKey="Korovkin S" first="Sergey" last="Korovkin">Sergey Korovkin</name></author><author><name sortKey="Mironov, Alexander" sort="Mironov, Alexander" uniqKey="Mironov A" first="Alexander" last="Mironov">Alexander Mironov</name></author><author><name sortKey="Rekstin, Andrey" sort="Rekstin, Andrey" uniqKey="Rekstin A" first="Andrey" last="Rekstin">Andrey Rekstin</name></author><author><name sortKey="Grigorieva, Elena" sort="Grigorieva, Elena" uniqKey="Grigorieva E" first="Elena" last="Grigorieva">Elena Grigorieva</name></author><author><name sortKey="Donina, Svetlana" sort="Donina, Svetlana" uniqKey="Donina S" first="Svetlana" last="Donina">Svetlana Donina</name></author><author><name sortKey="Gambaryan, Alexandra" sort="Gambaryan, Alexandra" uniqKey="Gambaryan A" first="Alexandra" last="Gambaryan">Alexandra Gambaryan</name></author><author><name sortKey="Katlinsky, Anton" sort="Katlinsky, Anton" uniqKey="Katlinsky A" first="Anton" last="Katlinsky">Anton Katlinsky</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2008">2008</date><idno type="RBID">pubmed:19453396</idno><idno type="pmid">19453396</idno><idno type="doi">10.1111/j.1750-2659.2008.00064.x</idno><idno type="wicri:Area/PubMed/Corpus">000234</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000234</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials).</title><author><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name><affiliation><nlm:affiliation>Institute of Experimental Medicine, Russian Academy of Medical Sciences, Acad. Pavlov's Street, Saint Petersburg, Russia. vaccine@mail.ru</nlm:affiliation></affiliation></author><author><name sortKey="Desheva, Julia" sort="Desheva, Julia" uniqKey="Desheva J" first="Julia" last="Desheva">Julia Desheva</name></author><author><name sortKey="Korovkin, Sergey" sort="Korovkin, Sergey" uniqKey="Korovkin S" first="Sergey" last="Korovkin">Sergey Korovkin</name></author><author><name sortKey="Mironov, Alexander" sort="Mironov, Alexander" uniqKey="Mironov A" first="Alexander" last="Mironov">Alexander Mironov</name></author><author><name sortKey="Rekstin, Andrey" sort="Rekstin, Andrey" uniqKey="Rekstin A" first="Andrey" last="Rekstin">Andrey Rekstin</name></author><author><name sortKey="Grigorieva, Elena" sort="Grigorieva, Elena" uniqKey="Grigorieva E" first="Elena" last="Grigorieva">Elena Grigorieva</name></author><author><name sortKey="Donina, Svetlana" sort="Donina, Svetlana" uniqKey="Donina S" first="Svetlana" last="Donina">Svetlana Donina</name></author><author><name sortKey="Gambaryan, Alexandra" sort="Gambaryan, Alexandra" uniqKey="Gambaryan A" first="Alexandra" last="Gambaryan">Alexandra Gambaryan</name></author><author><name sortKey="Katlinsky, Anton" sort="Katlinsky, Anton" uniqKey="Katlinsky A" first="Anton" last="Katlinsky">Anton Katlinsky</name></author></analytic><series><title level="j">Influenza and other respiratory viruses</title><idno type="eISSN">1750-2659</idno><imprint><date when="2008" type="published">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Intranasal</term><term>Antibodies, Viral (blood)</term><term>Cross Reactions</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Immunization, Secondary</term><term>Immunoglobulin A (analysis)</term><term>Influenza A Virus, H2N2 Subtype (genetics)</term><term>Influenza A Virus, H5N1 Subtype (immunology)</term><term>Influenza A Virus, H5N2 Subtype (genetics)</term><term>Influenza A Virus, H5N2 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>Nasal Mucosa (immunology)</term><term>Neutralization Tests</term><term>Reassortant Viruses (genetics)</term><term>Reassortant Viruses (immunology)</term><term>Russia</term><term>Vaccines, Attenuated (administration & dosage)</term><term>Vaccines, Attenuated (adverse effects)</term><term>Vaccines, Attenuated (immunology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>Immunoglobulin A</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Russia</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Influenza A Virus, H2N2 Subtype</term><term>Influenza A Virus, H5N2 Subtype</term><term>Reassortant Viruses</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H5N1 Subtype</term><term>Influenza A Virus, H5N2 Subtype</term><term>Influenza Vaccines</term><term>Nasal Mucosa</term><term>Reassortant Viruses</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Intranasal</term><term>Cross Reactions</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Immunization, Secondary</term><term>Neutralization Tests</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Our studies aimed to evaluate in clinical trials the safety and immunogenicity of an H5 live influenza vaccine candidate obtained using classical reassortment techniques from a low pathogenicity avian influenza (LPAI) A/Duck/Potsdam/1402-6/86(H5N2) virus and the cold-adapted (ca) donor strain A/Leningrad/134/17/57(H2N2).</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">19453396</PMID><DateCompleted><Year>2009</Year><Month>06</Month><Day>08</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1750-2659</ISSN><JournalIssue CitedMedium="Internet"><Volume>2</Volume><Issue>6</Issue><PubDate><Year>2008</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Influenza and other respiratory viruses</Title><ISOAbbreviation>Influenza Other Respir Viruses</ISOAbbreviation></Journal><ArticleTitle>Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials).</ArticleTitle><Pagination><MedlinePgn>203-9</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1111/j.1750-2659.2008.00064.x</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Our studies aimed to evaluate in clinical trials the safety and immunogenicity of an H5 live influenza vaccine candidate obtained using classical reassortment techniques from a low pathogenicity avian influenza (LPAI) A/Duck/Potsdam/1402-6/86(H5N2) virus and the cold-adapted (ca) donor strain A/Leningrad/134/17/57(H2N2).</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">During Phase I-II clinical trials, volunteers received intranasally two doses of reassortant influenza vaccine strain A/17/Duck/Potsdam/86/92 (H5N2) 21 days apart. Clinical examination of all vaccinees was conducted 7 days post-vaccination. Serum antibody responses were measured by hemagglutination-inhibition and microneutralization and local antibodies were estimated using an enzyme-linked immunosorbent assay test.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The vaccine was safe and of low reactogenicity with no febrile reactions. After revaccination 47.1-54.8% of subjects showed > or =fourfold seroconversions of Hamagglutination inhibition (HAI) antibodies to the hemagglutinin (HA) antigen of the A/17/Duck/Potsdam/86/92 (H5N2) virus and 29.4-30.8% were seroconverted to the HA antigen of the reverse genetics reassortant A/Indonesia/05/2005 x PR8 IBCDC-RG (H5N1). Virus-neutralizing antibody levels in sera of volunteers were similar to those shown in HAI test. The virus-specific nasal IgA antibody response after two vaccine doses demonstrated significant increases of > or =fourfold rise SIgA antibodies (65%) geometrical mean titers (16.0) and a rise in SIgA antibodies (2.8) compared with one dose.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The live attenuated influenza vaccine candidate prepared using the LPAI A(H5N2) strain was well tolerated and elicited serum and local immune responses. There was evident cross-reactivity to the A(H5N1) strain in the HAI test.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rudenko</LastName><ForeName>Larisa</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Institute of Experimental Medicine, Russian Academy of Medical Sciences, Acad. Pavlov's Street, Saint Petersburg, Russia. vaccine@mail.ru</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Desheva</LastName><ForeName>Julia</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Korovkin</LastName><ForeName>Sergey</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Mironov</LastName><ForeName>Alexander</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Rekstin</LastName><ForeName>Andrey</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Grigorieva</LastName><ForeName>Elena</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Donina</LastName><ForeName>Svetlana</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Gambaryan</LastName><ForeName>Alexandra</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Katlinsky</LastName><ForeName>Anton</ForeName><Initials>A</Initials></Author></AuthorList><Language>eng</Language><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="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Influenza Other Respir Viruses</MedlineTA><NlmUniqueID>101304007</NlmUniqueID><ISSNLinking>1750-2640</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007070">Immunoglobulin 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MajorTopicYN="N">Immunization, Secondary</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007070" MajorTopicYN="N">Immunoglobulin A</DescriptorName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D053121" MajorTopicYN="N">Influenza A Virus, H2N2 Subtype</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D053124" MajorTopicYN="N">Influenza A Virus, H5N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D053125" MajorTopicYN="N">Influenza A Virus, H5N2 Subtype</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="Y">genetics</QualifierName><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="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="D009297" MajorTopicYN="N">Nasal Mucosa</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009500" MajorTopicYN="N">Neutralization Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016865" MajorTopicYN="N">Reassortant Viruses</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012426" 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