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<title xml:lang="en">H5N1 vaccines in humans</title>
<author>
<name sortKey="Baz, Mariana" sort="Baz, Mariana" uniqKey="Baz M" first="Mariana" last="Baz">Mariana Baz</name>
<affiliation>
<nlm:aff id="A1">Laboratory of Infectious Diseases, NIAID, NIH, Bethesda, Maryland, USA.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Luke, Catherine J" sort="Luke, Catherine J" uniqKey="Luke C" first="Catherine J" last="Luke">Catherine J. Luke</name>
<affiliation>
<nlm:aff id="A1">Laboratory of Infectious Diseases, NIAID, NIH, Bethesda, Maryland, USA.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Cheng, Xing" sort="Cheng, Xing" uniqKey="Cheng X" first="Xing" last="Cheng">Xing Cheng</name>
<affiliation>
<nlm:aff id="A2">MedImmune, Mountain View, California.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Jin, Hong" sort="Jin, Hong" uniqKey="Jin H" first="Hong" last="Jin">Hong Jin</name>
<affiliation>
<nlm:aff id="A2">MedImmune, Mountain View, California.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Subbarao, Kanta" sort="Subbarao, Kanta" uniqKey="Subbarao K" first="Kanta" last="Subbarao">Kanta Subbarao</name>
<affiliation>
<nlm:aff id="A1">Laboratory of Infectious Diseases, NIAID, NIH, Bethesda, Maryland, USA.</nlm:aff>
</affiliation>
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<idno type="pmid">23726847</idno>
<idno type="pmc">3795810</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795810</idno>
<idno type="RBID">PMC:3795810</idno>
<idno type="doi">10.1016/j.virusres.2013.05.006</idno>
<date when="2013">2013</date>
<idno type="wicri:Area/Pmc/Corpus">000871</idno>
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<title xml:lang="en" level="a" type="main">H5N1 vaccines in humans</title>
<author>
<name sortKey="Baz, Mariana" sort="Baz, Mariana" uniqKey="Baz M" first="Mariana" last="Baz">Mariana Baz</name>
<affiliation>
<nlm:aff id="A1">Laboratory of Infectious Diseases, NIAID, NIH, Bethesda, Maryland, USA.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Luke, Catherine J" sort="Luke, Catherine J" uniqKey="Luke C" first="Catherine J" last="Luke">Catherine J. Luke</name>
<affiliation>
<nlm:aff id="A1">Laboratory of Infectious Diseases, NIAID, NIH, Bethesda, Maryland, USA.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Cheng, Xing" sort="Cheng, Xing" uniqKey="Cheng X" first="Xing" last="Cheng">Xing Cheng</name>
<affiliation>
<nlm:aff id="A2">MedImmune, Mountain View, California.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Jin, Hong" sort="Jin, Hong" uniqKey="Jin H" first="Hong" last="Jin">Hong Jin</name>
<affiliation>
<nlm:aff id="A2">MedImmune, Mountain View, California.</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Subbarao, Kanta" sort="Subbarao, Kanta" uniqKey="Subbarao K" first="Kanta" last="Subbarao">Kanta Subbarao</name>
<affiliation>
<nlm:aff id="A1">Laboratory of Infectious Diseases, NIAID, NIH, Bethesda, Maryland, USA.</nlm:aff>
</affiliation>
</author>
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<series>
<title level="j">Virus research</title>
<idno type="ISSN">0168-1702</idno>
<idno type="eISSN">1872-7492</idno>
<imprint>
<date when="2013">2013</date>
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<p id="P1">The spread of highly pathogenic avian H5N1 influenza viruses since 1997 and their virulence for poultry and humans has raised concerns about their potential to cause an influenza pandemic. Vaccines offer the most viable means to combat a pandemic threat. However, it will be a challenge to produce, distribute and implement a new vaccine if a pandemic spreads rapidly. Therefore, efforts are being undertaken to develop pandemic vaccines that use less antigen and induce cross-protective and long-lasting responses, that can be administered as soon as a pandemic is declared or possibly even before, in order to prime the population and allow for a rapid and protective antibody response. In the last few years, several vaccine manufacturers have developed candidate pandemic and pre-pandemic vaccines, based on reverse genetics and have improved the immunogenicity by formulating these vaccines with different adjuvants. Some of the important and consistent observations from clinical studies with H5N1 vaccines are as follows: two doses of inactivated vaccine are generally necessary to elicit the level of immunity required to meet licensure criteria, less antigen can be used if an oil-in-water adjuvant is included, in general antibody titers decline rapidly but can be boosted with additional doses of vaccine and if high titers of antibody are elicited, cross-reactivity against other clades is observed. Prime-boost strategies elicit a more robust immune response. In this review, we discuss data from clinical trials with a variety of H5N1 influenza vaccines. We also describe studies conducted in animal models to explore the possibility of reassortment between pandemic live attenuated vaccine candidates and seasonal influenza viruses, since this is an important consideration for the use of live vaccines in a pandemic setting.</p>
</div>
</front>
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<pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-journal-id">8410979</journal-id>
<journal-id journal-id-type="pubmed-jr-id">7967</journal-id>
<journal-id journal-id-type="nlm-ta">Virus Res</journal-id>
<journal-id journal-id-type="iso-abbrev">Virus Res.</journal-id>
<journal-title-group>
<journal-title>Virus research</journal-title>
</journal-title-group>
<issn pub-type="ppub">0168-1702</issn>
<issn pub-type="epub">1872-7492</issn>
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<article-meta>
<article-id pub-id-type="pmid">23726847</article-id>
<article-id pub-id-type="pmc">3795810</article-id>
<article-id pub-id-type="doi">10.1016/j.virusres.2013.05.006</article-id>
<article-id pub-id-type="manuscript">NIHMS486329</article-id>
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<subj-group subj-group-type="heading">
<subject>Article</subject>
</subj-group>
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<title-group>
<article-title>H5N1 vaccines in humans</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Baz</surname>
<given-names>Mariana</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Luke</surname>
<given-names>Catherine J</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Cheng</surname>
<given-names>Xing</given-names>
</name>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Jin</surname>
<given-names>Hong</given-names>
</name>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Subbarao</surname>
<given-names>Kanta</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
<xref ref-type="corresp" rid="CR1">*</xref>
</contrib>
</contrib-group>
<aff id="A1">
<label>1</label>
Laboratory of Infectious Diseases, NIAID, NIH, Bethesda, Maryland, USA.</aff>
<aff id="A2">
<label>2</label>
MedImmune, Mountain View, California.</aff>
<author-notes>
<corresp id="CR1">
<label>*</label>
Corresponding author: Kanta Subbarao, MD, MPH Emerging Respiratory Viruses Section Laboratory of Infectious Diseases, NIAID, NIH Bldg 33, Room 3E13C.1, 33 North Drive, MSC 3203 Bethesda, MD 20892-3203 Phone: 301-451-3839 Fax: 301-480-4749
<email>ksubbarao@niaid.nih.gov</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted">
<day>18</day>
<month>6</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="epub">
<day>28</day>
<month>5</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="ppub">
<day>5</day>
<month>12</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>05</day>
<month>12</month>
<year>2014</year>
</pub-date>
<volume>178</volume>
<issue>1</issue>
<elocation-id>10.1016/j.virusres.2013.05.006</elocation-id>
<abstract>
<p id="P1">The spread of highly pathogenic avian H5N1 influenza viruses since 1997 and their virulence for poultry and humans has raised concerns about their potential to cause an influenza pandemic. Vaccines offer the most viable means to combat a pandemic threat. However, it will be a challenge to produce, distribute and implement a new vaccine if a pandemic spreads rapidly. Therefore, efforts are being undertaken to develop pandemic vaccines that use less antigen and induce cross-protective and long-lasting responses, that can be administered as soon as a pandemic is declared or possibly even before, in order to prime the population and allow for a rapid and protective antibody response. In the last few years, several vaccine manufacturers have developed candidate pandemic and pre-pandemic vaccines, based on reverse genetics and have improved the immunogenicity by formulating these vaccines with different adjuvants. Some of the important and consistent observations from clinical studies with H5N1 vaccines are as follows: two doses of inactivated vaccine are generally necessary to elicit the level of immunity required to meet licensure criteria, less antigen can be used if an oil-in-water adjuvant is included, in general antibody titers decline rapidly but can be boosted with additional doses of vaccine and if high titers of antibody are elicited, cross-reactivity against other clades is observed. Prime-boost strategies elicit a more robust immune response. In this review, we discuss data from clinical trials with a variety of H5N1 influenza vaccines. We also describe studies conducted in animal models to explore the possibility of reassortment between pandemic live attenuated vaccine candidates and seasonal influenza viruses, since this is an important consideration for the use of live vaccines in a pandemic setting.</p>
</abstract>
<kwd-group>
<kwd>H5N1</kwd>
<kwd>vaccine strategies</kwd>
<kwd>pandemic</kwd>
<kwd>adjuvants</kwd>
<kwd>clinical trials</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
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