H2N2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers.
Identifieur interne : 000071 ( PubMed/Checkpoint ); précédent : 000070; suivant : 000072H2N2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers.
Auteurs : Irina Isakova-Sivak [Russie] ; Marina Stukova ; Mariana Erofeeva ; Anatoly Naykhin ; Svetlana Donina ; Galina Petukhova ; Victoria Kuznetsova ; Irina Kiseleva ; Tatiana Smolonogina ; Irina Dubrovina ; Maria Pisareva ; Alexandra Nikiforova ; Maureen Power ; Jorge Flores ; Larisa RudenkoSource :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2015.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Femelle, Grippe humaine (), Humains, Jeune adulte, Mâle, Méthode en double aveugle, Sous-type H2N2 du virus de la grippe A (immunologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins antigrippaux (usage thérapeutique), Volontaires sains.
- MESH :
- effets indésirables : Vaccins antigrippaux.
- immunologie : Sous-type H2N2 du virus de la grippe A, Vaccins antigrippaux.
- usage thérapeutique : Vaccins antigrippaux.
- Adolescent, Adulte, Femelle, Grippe humaine, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Volontaires sains.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Influenza Vaccines.
- immunology : Influenza A Virus, H2N2 Subtype, Influenza Vaccines.
- prevention & control : Influenza, Human.
- chemical , therapeutic use : Influenza Vaccines.
- Adolescent, Adult, Double-Blind Method, Female, Healthy Volunteers, Humans, Male, Young Adult.
Abstract
H2N2 influenza viruses have not circulated in the human population since 1968, but they are still being regularly detected in the animal reservoir, suggesting their high pandemic potential. To prepare for a possible H2N2 pandemic, a number of H2N2 vaccine candidates have been generated and tested in preclinical and clinical studies. Here we describe the results of a randomized, double-blind placebo-controlled phase 1 clinical trial of an H2N2 live attenuated influenza vaccine (LAIV) candidate prepared from a human influenza virus isolated in 1966. The vaccine candidate was safe and well-tolerated by healthy adults, and did not cause serious adverse events or an increased rate of moderate or severe reactogenicities. The H2N2 vaccine virus was infectious for Humans. It was shed by 78.6% and 74.1% volunteers after the first and second dose, respectively, most probably due to the human origin of the virus. Importantly, no vaccine virus transmission to unvaccinated subjects was detected during the study. We employed multiple immunological tests to ensure the adequate assessment of the H2N2 pandemic LAIV candidate and demonstrated that the majority (92.6%) of the vaccinated subjects responded to the H2N2 LAIV in one or more immunological tests, including 85.2% of subjects with antibody responses and 55.6% volunteers with cell-mediated immune responses. In addition, we observed strong correlation between the H2N2 LAIV virus replication in the upper respiratory tract and the development of antibody responses.
DOI: 10.1080/21645515.2015.1010859
PubMed: 25831405
Affiliations:
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</wicri:regionArea></affiliation></author><author><name sortKey="Stukova, Marina" sort="Stukova, Marina" uniqKey="Stukova M" first="Marina" last="Stukova">Marina Stukova</name></author><author><name sortKey="Erofeeva, Mariana" sort="Erofeeva, Mariana" uniqKey="Erofeeva M" first="Mariana" last="Erofeeva">Mariana Erofeeva</name></author><author><name sortKey="Naykhin, Anatoly" sort="Naykhin, Anatoly" uniqKey="Naykhin A" first="Anatoly" last="Naykhin">Anatoly Naykhin</name></author><author><name sortKey="Donina, Svetlana" sort="Donina, Svetlana" uniqKey="Donina S" first="Svetlana" last="Donina">Svetlana Donina</name></author><author><name sortKey="Petukhova, Galina" sort="Petukhova, Galina" uniqKey="Petukhova G" first="Galina" last="Petukhova">Galina Petukhova</name></author><author><name sortKey="Kuznetsova, Victoria" sort="Kuznetsova, Victoria" uniqKey="Kuznetsova V" first="Victoria" last="Kuznetsova">Victoria Kuznetsova</name></author><author><name sortKey="Kiseleva, Irina" 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Flores</name></author><author><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name></author></analytic><series><title level="j">Human vaccines & immunotherapeutics</title><idno type="eISSN">2164-554X</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>Double-Blind Method</term><term>Female</term><term>Healthy Volunteers</term><term>Humans</term><term>Influenza A Virus, H2N2 Subtype (immunology)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza Vaccines (immunology)</term><term>Influenza Vaccines (therapeutic use)</term><term>Influenza, Human (prevention & control)</term><term>Male</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Femelle</term><term>Grippe humaine ()</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Sous-type H2N2 du virus de la grippe A (immunologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Vaccins antigrippaux (immunologie)</term><term>Vaccins antigrippaux (usage thérapeutique)</term><term>Volontaires sains</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Sous-type H2N2 du virus de la grippe A</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H2N2 Subtype</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Vaccins antigrippaux</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>Humans</term><term>Male</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Volontaires sains</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">H2N2 influenza viruses have not circulated in the human population since 1968, but they are still being regularly detected in the animal reservoir, suggesting their high pandemic potential. To prepare for a possible H2N2 pandemic, a number of H2N2 vaccine candidates have been generated and tested in preclinical and clinical studies. Here we describe the results of a randomized, double-blind placebo-controlled phase 1 clinical trial of an H2N2 live attenuated influenza vaccine (LAIV) candidate prepared from a human influenza virus isolated in 1966. The vaccine candidate was safe and well-tolerated by healthy adults, and did not cause serious adverse events or an increased rate of moderate or severe reactogenicities. The H2N2 vaccine virus was infectious for Humans. It was shed by 78.6% and 74.1% volunteers after the first and second dose, respectively, most probably due to the human origin of the virus. Importantly, no vaccine virus transmission to unvaccinated subjects was detected during the study. We employed multiple immunological tests to ensure the adequate assessment of the H2N2 pandemic LAIV candidate and demonstrated that the majority (92.6%) of the vaccinated subjects responded to the H2N2 LAIV in one or more immunological tests, including 85.2% of subjects with antibody responses and 55.6% volunteers with cell-mediated immune responses. In addition, we observed strong correlation between the H2N2 LAIV virus replication in the upper respiratory tract and the development of antibody responses. </div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25831405</PMID><DateCompleted><Year>2016</Year><Month>02</Month><Day>04</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2164-554X</ISSN><JournalIssue CitedMedium="Internet"><Volume>11</Volume><Issue>4</Issue><PubDate><Year>2015</Year></PubDate></JournalIssue><Title>Human vaccines & immunotherapeutics</Title><ISOAbbreviation>Hum Vaccin Immunother</ISOAbbreviation></Journal><ArticleTitle>H2N2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers.</ArticleTitle><Pagination><MedlinePgn>970-82</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/21645515.2015.1010859</ELocationID><Abstract><AbstractText>H2N2 influenza viruses have not circulated in the human population since 1968, but they are still being regularly detected in the animal reservoir, suggesting their high pandemic potential. To prepare for a possible H2N2 pandemic, a number of H2N2 vaccine candidates have been generated and tested in preclinical and clinical studies. Here we describe the results of a randomized, double-blind placebo-controlled phase 1 clinical trial of an H2N2 live attenuated influenza vaccine (LAIV) candidate prepared from a human influenza virus isolated in 1966. The vaccine candidate was safe and well-tolerated by healthy adults, and did not cause serious adverse events or an increased rate of moderate or severe reactogenicities. The H2N2 vaccine virus was infectious for Humans. It was shed by 78.6% and 74.1% volunteers after the first and second dose, respectively, most probably due to the human origin of the virus. Importantly, no vaccine virus transmission to unvaccinated subjects was detected during the study. We employed multiple immunological tests to ensure the adequate assessment of the H2N2 pandemic LAIV candidate and demonstrated that the majority (92.6%) of the vaccinated subjects responded to the H2N2 LAIV in one or more immunological tests, including 85.2% of subjects with antibody responses and 55.6% volunteers with cell-mediated immune responses. In addition, we observed strong correlation between the H2N2 LAIV virus replication in the upper respiratory tract and the development of antibody responses. </AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Isakova-Sivak</LastName><ForeName>Irina</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>a Institute of Experimental Medicine RAMS ; Saint Petersburg , Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stukova</LastName><ForeName>Marina</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Erofeeva</LastName><ForeName>Mariana</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Naykhin</LastName><ForeName>Anatoly</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Donina</LastName><ForeName>Svetlana</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Petukhova</LastName><ForeName>Galina</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Kuznetsova</LastName><ForeName>Victoria</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Kiseleva</LastName><ForeName>Irina</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Smolonogina</LastName><ForeName>Tatiana</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Dubrovina</LastName><ForeName>Irina</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Pisareva</LastName><ForeName>Maria</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Nikiforova</LastName><ForeName>Alexandra</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Power</LastName><ForeName>Maureen</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Flores</LastName><ForeName>Jorge</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Rudenko</LastName><ForeName>Larisa</ForeName><Initials>L</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><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>United States</Country><MedlineTA>Hum Vaccin Immunother</MedlineTA><NlmUniqueID>101572652</NlmUniqueID><ISSNLinking>2164-5515</ISSNLinking></MedlineJournalInfo><ChemicalList><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="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064368" MajorTopicYN="N">Healthy Volunteers</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053121" MajorTopicYN="N">Influenza A Virus, H2N2 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">clinical trial</Keyword><Keyword MajorTopicYN="N">immunogenicity</Keyword><Keyword MajorTopicYN="N">influenza H2N2</Keyword><Keyword MajorTopicYN="N">live attenuated influenza vaccine</Keyword><Keyword MajorTopicYN="N">pandemic</Keyword><Keyword MajorTopicYN="N">safety</Keyword><Keyword MajorTopicYN="N">transmissibility</Keyword><Keyword MajorTopicYN="N">vaccine virus shedding</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate 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Flores</name><name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</name><name sortKey="Kuznetsova, Victoria" sort="Kuznetsova, Victoria" uniqKey="Kuznetsova V" first="Victoria" last="Kuznetsova">Victoria Kuznetsova</name><name sortKey="Naykhin, Anatoly" sort="Naykhin, Anatoly" uniqKey="Naykhin A" first="Anatoly" last="Naykhin">Anatoly Naykhin</name><name sortKey="Nikiforova, Alexandra" sort="Nikiforova, Alexandra" uniqKey="Nikiforova A" first="Alexandra" last="Nikiforova">Alexandra Nikiforova</name><name sortKey="Petukhova, Galina" sort="Petukhova, Galina" uniqKey="Petukhova G" first="Galina" last="Petukhova">Galina Petukhova</name><name sortKey="Pisareva, Maria" sort="Pisareva, Maria" uniqKey="Pisareva M" first="Maria" last="Pisareva">Maria Pisareva</name><name sortKey="Power, Maureen" sort="Power, Maureen" uniqKey="Power M" first="Maureen" last="Power">Maureen Power</name><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name><name sortKey="Smolonogina, Tatiana" sort="Smolonogina, Tatiana" uniqKey="Smolonogina T" first="Tatiana" last="Smolonogina">Tatiana Smolonogina</name><name sortKey="Stukova, Marina" sort="Stukova, Marina" uniqKey="Stukova M" first="Marina" last="Stukova">Marina Stukova</name></noCountry><country name="Russie"><noRegion><name sortKey="Isakova Sivak, Irina" sort="Isakova Sivak, Irina" uniqKey="Isakova Sivak I" first="Irina" last="Isakova-Sivak">Irina Isakova-Sivak</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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