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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">H2N2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers</title>
<author><name sortKey="Isakova Sivak, Irina" sort="Isakova Sivak, Irina" uniqKey="Isakova Sivak I" first="Irina" last="Isakova-Sivak">Irina Isakova-Sivak</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Stukova, Marina" sort="Stukova, Marina" uniqKey="Stukova M" first="Marina" last="Stukova">Marina Stukova</name>
<affiliation><nlm:aff id="af0002"><institution>Research Institute of Influenza;</institution>
Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Erofeeva, Mariana" sort="Erofeeva, Mariana" uniqKey="Erofeeva M" first="Mariana" last="Erofeeva">Mariana Erofeeva</name>
<affiliation><nlm:aff id="af0002"><institution>Research Institute of Influenza;</institution>
Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Naykhin, Anatoly" sort="Naykhin, Anatoly" uniqKey="Naykhin A" first="Anatoly" last="Naykhin">Anatoly Naykhin</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Donina, Svetlana" sort="Donina, Svetlana" uniqKey="Donina S" first="Svetlana" last="Donina">Svetlana Donina</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Petukhova, Galina" sort="Petukhova, Galina" uniqKey="Petukhova G" first="Galina" last="Petukhova">Galina Petukhova</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kuznetsova, Victoria" sort="Kuznetsova, Victoria" uniqKey="Kuznetsova V" first="Victoria" last="Kuznetsova">Victoria Kuznetsova</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Smolonogina, Tatiana" sort="Smolonogina, Tatiana" uniqKey="Smolonogina T" first="Tatiana" last="Smolonogina">Tatiana Smolonogina</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Dubrovina, Irina" sort="Dubrovina, Irina" uniqKey="Dubrovina I" first="Irina" last="Dubrovina">Irina Dubrovina</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pisareva, Maria" sort="Pisareva, Maria" uniqKey="Pisareva M" first="Maria" last="Pisareva">Maria Pisareva</name>
<affiliation><nlm:aff id="af0002"><institution>Research Institute of Influenza;</institution>
Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Nikiforova, Alexandra" sort="Nikiforova, Alexandra" uniqKey="Nikiforova A" first="Alexandra" last="Nikiforova">Alexandra Nikiforova</name>
<affiliation><nlm:aff id="af0003"><institution>Department of Preclinical Trials; Microgen</institution>
, Moscow,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Power, Maureen" sort="Power, Maureen" uniqKey="Power M" first="Maureen" last="Power">Maureen Power</name>
<affiliation><nlm:aff id="af0004"><institution>PATH;</institution>
Seattle, WA<country>USA</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Flores, Jorge" sort="Flores, Jorge" uniqKey="Flores J" first="Jorge" last="Flores">Jorge Flores</name>
<affiliation><nlm:aff id="af0004"><institution>PATH;</institution>
Seattle, WA<country>USA</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">25831405</idno>
<idno type="pmc">4514355</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4514355</idno>
<idno type="RBID">PMC:4514355</idno>
<idno type="doi">10.1080/21645515.2015.1010859</idno>
<date when="2015">2015</date>
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<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000017</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">H2N2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers</title>
<author><name sortKey="Isakova Sivak, Irina" sort="Isakova Sivak, Irina" uniqKey="Isakova Sivak I" first="Irina" last="Isakova-Sivak">Irina Isakova-Sivak</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Stukova, Marina" sort="Stukova, Marina" uniqKey="Stukova M" first="Marina" last="Stukova">Marina Stukova</name>
<affiliation><nlm:aff id="af0002"><institution>Research Institute of Influenza;</institution>
Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Erofeeva, Mariana" sort="Erofeeva, Mariana" uniqKey="Erofeeva M" first="Mariana" last="Erofeeva">Mariana Erofeeva</name>
<affiliation><nlm:aff id="af0002"><institution>Research Institute of Influenza;</institution>
Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Naykhin, Anatoly" sort="Naykhin, Anatoly" uniqKey="Naykhin A" first="Anatoly" last="Naykhin">Anatoly Naykhin</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Donina, Svetlana" sort="Donina, Svetlana" uniqKey="Donina S" first="Svetlana" last="Donina">Svetlana Donina</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Petukhova, Galina" sort="Petukhova, Galina" uniqKey="Petukhova G" first="Galina" last="Petukhova">Galina Petukhova</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kuznetsova, Victoria" sort="Kuznetsova, Victoria" uniqKey="Kuznetsova V" first="Victoria" last="Kuznetsova">Victoria Kuznetsova</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Smolonogina, Tatiana" sort="Smolonogina, Tatiana" uniqKey="Smolonogina T" first="Tatiana" last="Smolonogina">Tatiana Smolonogina</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Dubrovina, Irina" sort="Dubrovina, Irina" uniqKey="Dubrovina I" first="Irina" last="Dubrovina">Irina Dubrovina</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pisareva, Maria" sort="Pisareva, Maria" uniqKey="Pisareva M" first="Maria" last="Pisareva">Maria Pisareva</name>
<affiliation><nlm:aff id="af0002"><institution>Research Institute of Influenza;</institution>
Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Nikiforova, Alexandra" sort="Nikiforova, Alexandra" uniqKey="Nikiforova A" first="Alexandra" last="Nikiforova">Alexandra Nikiforova</name>
<affiliation><nlm:aff id="af0003"><institution>Department of Preclinical Trials; Microgen</institution>
, Moscow,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Power, Maureen" sort="Power, Maureen" uniqKey="Power M" first="Maureen" last="Power">Maureen Power</name>
<affiliation><nlm:aff id="af0004"><institution>PATH;</institution>
Seattle, WA<country>USA</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Flores, Jorge" sort="Flores, Jorge" uniqKey="Flores J" first="Jorge" last="Flores">Jorge Flores</name>
<affiliation><nlm:aff id="af0004"><institution>PATH;</institution>
Seattle, WA<country>USA</country>
</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name>
<affiliation><nlm:aff id="af0001"><institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">Human Vaccines & Immunotherapeutics</title>
<idno type="ISSN">2164-5515</idno>
<idno type="eISSN">2164-554X</idno>
<imprint><date when="2015">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p>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.</p>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Hum Vaccin Immunother</journal-id>
<journal-id journal-id-type="iso-abbrev">Hum Vaccin Immunother</journal-id>
<journal-id journal-id-type="pmc">KHVI</journal-id>
<journal-title-group><journal-title>Human Vaccines & Immunotherapeutics</journal-title>
</journal-title-group>
<issn pub-type="ppub">2164-5515</issn>
<issn pub-type="epub">2164-554X</issn>
<publisher><publisher-name>Taylor & Francis</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">25831405</article-id>
<article-id pub-id-type="pmc">4514355</article-id>
<article-id pub-id-type="publisher-id">1010859</article-id>
<article-id pub-id-type="doi">10.1080/21645515.2015.1010859</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Research Paper</subject>
</subj-group>
</article-categories>
<title-group><article-title>H2N2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Isakova-Sivak</surname>
<given-names>Irina</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
<xref ref-type="corresp" rid="an0001"><sup>*</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Stukova</surname>
<given-names>Marina</given-names>
</name>
<xref ref-type="aff" rid="af0002"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Erofeeva</surname>
<given-names>Mariana</given-names>
</name>
<xref ref-type="aff" rid="af0002"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Naykhin</surname>
<given-names>Anatoly</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Donina</surname>
<given-names>Svetlana</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Petukhova</surname>
<given-names>Galina</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kuznetsova</surname>
<given-names>Victoria</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kiseleva</surname>
<given-names>Irina</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Smolonogina</surname>
<given-names>Tatiana</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Dubrovina</surname>
<given-names>Irina</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pisareva</surname>
<given-names>Maria</given-names>
</name>
<xref ref-type="aff" rid="af0002"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nikiforova</surname>
<given-names>Alexandra</given-names>
</name>
<xref ref-type="aff" rid="af0003"><sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Power</surname>
<given-names>Maureen</given-names>
</name>
<xref ref-type="aff" rid="af0004"><sup>4</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Flores</surname>
<given-names>Jorge</given-names>
</name>
<xref ref-type="aff" rid="af0004"><sup>4</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Rudenko</surname>
<given-names>Larisa</given-names>
</name>
<xref ref-type="aff" rid="af0001"><sup>1</sup>
</xref>
</contrib>
<aff id="af0001"><label>1</label>
<institution>Institute of Experimental Medicine RAMS</institution>
; Saint Petersburg,<country>Russia</country>
</aff>
<aff id="af0002"><label>2</label>
<institution>Research Institute of Influenza;</institution>
Saint Petersburg,<country>Russia</country>
</aff>
<aff id="af0003"><label>3</label>
<institution>Department of Preclinical Trials; Microgen</institution>
, Moscow,<country>Russia</country>
</aff>
<aff id="af0004"><label>4</label>
<institution>PATH;</institution>
Seattle, WA<country>USA</country>
</aff>
</contrib-group>
<author-notes><corresp id="an0001"><label>*</label>
Correspondence to: Irina Isakova-Sivak; Email: <email xlink:href="isakova.sivak@gmail.com">isakova.sivak@gmail.com</email>
</corresp>
</author-notes>
<pub-date pub-type="epub"><day>1</day>
<month>4</month>
<year>2015</year>
</pub-date>
<pub-date pub-type="collection"><month>4</month>
<year>2015</year>
</pub-date>
<volume>11</volume>
<issue>4</issue>
<fpage seq="22">970</fpage>
<lpage>982</lpage>
<history><date date-type="received"><day>10</day>
<month>11</month>
<year>2014</year>
</date>
<date date-type="rev-recd"><day>23</day>
<month>12</month>
<year>2014</year>
</date>
<date date-type="accepted"><day>5</day>
<month>1</month>
<year>2015</year>
</date>
</history>
<permissions><copyright-statement>© 2015 Taylor & Francis Group, LLC</copyright-statement>
<copyright-year>2015</copyright-year>
<copyright-holder>Taylor & Francis Group, LLC</copyright-holder>
</permissions>
<self-uri content-type="pdf" xlink:href="khvi-11-04-1010859.pdf"></self-uri>
<abstract><p>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.</p>
</abstract>
<kwd-group kwd-group-type="author"><title>Keywords</title>
<kwd>clinical trial</kwd>
<kwd>immunogenicity</kwd>
<kwd>influenza H2N2</kwd>
<kwd>live attenuated influenza vaccine</kwd>
<kwd>pandemic</kwd>
<kwd>safety</kwd>
<kwd>transmissibility</kwd>
<kwd>vaccine virus shedding</kwd>
</kwd-group>
<counts><fig-count count="1"></fig-count>
<table-count count="9"></table-count>
<ref-count count="52"></ref-count>
<page-count count="13"></page-count>
</counts>
</article-meta>
</front>
</pmc>
</record>
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