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Development of a new candidate H5N1 avian influenza virus for pre‐pandemic vaccine production

Identifieur interne : 000067 ( Pmc/Curation ); précédent : 000066; suivant : 000068

Development of a new candidate H5N1 avian influenza virus for pre‐pandemic vaccine production

Auteurs : Jie Dong ; Yumiko Matsuoka ; Taronna R. Maines ; David E. Swayne ; Eduardo O Eill ; C. Todd Davis ; Neal Van-Hoven ; Amanda Balish ; Hong-Jie Yu ; Jacqueline M. Katz ; Alexander Klimov ; Nancy Cox ; De-Xin Li ; Yu Wang ; Yuan-Ji Guo ; Wei-Zhong Yang ; Ruben O. Donis ; Yue-Long Shu

Source :

RBID : PMC:4941393

Abstract

Background  Highly pathogenic H5N1 avian influenza viruses currently circulating in birds have caused hundreds of human infections, and pose a significant pandemic threat. Vaccines are a major component of the public health preparedness for this likely event. The rapid evolution of H5N1 viruses has resulted in the emergence of multiple clades with distinct antigenic characteristics that require clade‐specific vaccines. A variant H5N1 virus termed clade 2.3.4 emerged in 2005 and has caused multiple fatal infections. Vaccine candidates that match the antigenic properties of variant viruses are necessary because inactivated influenza vaccines elicit strain‐specific protection.

Objective  To address the need for a suitable seed for manufacturing a clade 2.3.4 vaccine, we developed a new H5N1 pre‐pandemic candidate vaccine by reverse genetics and evaluated its safety and replication in vitro and in vivo.

Methods  A reassortant virus termed, Anhui/PR8, was produced by reverse genetics in compliance with WHO pandemic vaccine development guidelines and contains six genes from A/Puerto Rico/8/34 as well as the neuraminidase and hemagglutinin (HA) genomic segments from the A/Anhui/01/2005 virus. The multi‐basic cleavage site of HA was removed to reduce virulence.

Results  The reassortant Anhui/PR8 grows well in eggs and is avirulent to chicken and ferrets but retains the antigenicity of the parental A/Anhui/01/2005 virus.

Conclusion  These results indicate that the Anhui/PR8 reassortant lost a major virulent determinant and it is suitable for its use in vaccine manufacturing and as a reference vaccine virus against the H5N1 clade 2.3.4 viruses circulating in eastern China, Vietnam, Thailand, and Laos.


Url:
DOI: 10.1111/j.1750-2659.2009.00104.x
PubMed: 19903211
PubMed Central: 4941393

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PMC:4941393

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<name sortKey="Yang, Wei Hong" sort="Yang, Wei Hong" uniqKey="Yang W" first="Wei-Zhong" last="Yang">Wei-Zhong Yang</name>
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<name sortKey="Donis, Ruben O" sort="Donis, Ruben O" uniqKey="Donis R" first="Ruben O." last="Donis">Ruben O. Donis</name>
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<name sortKey="Shu, Yue Ong" sort="Shu, Yue Ong" uniqKey="Shu Y" first="Yue-Long" last="Shu">Yue-Long Shu</name>
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<p>
<bold>Background </bold>
Highly pathogenic H5N1 avian influenza viruses currently circulating in birds have caused hundreds of human infections, and pose a significant pandemic threat. Vaccines are a major component of the public health preparedness for this likely event. The rapid evolution of H5N1 viruses has resulted in the emergence of multiple clades with distinct antigenic characteristics that require clade‐specific vaccines. A variant H5N1 virus termed clade 2.3.4 emerged in 2005 and has caused multiple fatal infections. Vaccine candidates that match the antigenic properties of variant viruses are necessary because inactivated influenza vaccines elicit strain‐specific protection.</p>
<p>
<bold>Objective </bold>
To address the need for a suitable seed for manufacturing a clade 2.3.4 vaccine, we developed a new H5N1 pre‐pandemic candidate vaccine by reverse genetics and evaluated its safety and replication
<italic>in vitro</italic>
and
<italic>in vivo</italic>
.</p>
<p>
<bold>Methods </bold>
A reassortant virus termed, Anhui/PR8, was produced by reverse genetics in compliance with WHO pandemic vaccine development guidelines and contains six genes from A/Puerto Rico/8/34 as well as the neuraminidase and hemagglutinin (HA) genomic segments from the A/Anhui/01/2005 virus. The multi‐basic cleavage site of HA was removed to reduce virulence.</p>
<p>
<bold>Results </bold>
The reassortant Anhui/PR8 grows well in eggs and is avirulent to chicken and ferrets but retains the antigenicity of the parental A/Anhui/01/2005 virus.</p>
<p>
<bold>Conclusion </bold>
These results indicate that the Anhui/PR8 reassortant lost a major virulent determinant and it is suitable for its use in vaccine manufacturing and as a reference vaccine virus against the H5N1 clade 2.3.4 viruses circulating in eastern China, Vietnam, Thailand, and Laos.</p>
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<journal-id journal-id-type="nlm-ta">Influenza Other Respir Viruses</journal-id>
<journal-id journal-id-type="iso-abbrev">Influenza Other Respir Viruses</journal-id>
<journal-id journal-id-type="doi">10.1111/(ISSN)1750-2659</journal-id>
<journal-id journal-id-type="publisher-id">IRV</journal-id>
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<journal-title>Influenza and Other Respiratory Viruses</journal-title>
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<issn pub-type="ppub">1750-2640</issn>
<issn pub-type="epub">1750-2659</issn>
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<article-id pub-id-type="pmid">19903211</article-id>
<article-id pub-id-type="pmc">4941393</article-id>
<article-id pub-id-type="doi">10.1111/j.1750-2659.2009.00104.x</article-id>
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<subject>Original Articles</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Development of a new candidate H5N1 avian influenza virus for pre‐pandemic vaccine production</article-title>
<alt-title alt-title-type="left-running-head">Dong
<italic>et al.</italic>
</alt-title>
<alt-title alt-title-type="right-running-head">Anhui/PR8 candidate vaccine virus derivation</alt-title>
</title-group>
<contrib-group>
<contrib id="cr1" contrib-type="author">
<name>
<surname>Dong</surname>
<given-names>Jie</given-names>
</name>
<xref ref-type="aff" rid="a1">
<sup>1</sup>
</xref>
</contrib>
<contrib id="cr2" contrib-type="author">
<name>
<surname>Matsuoka</surname>
<given-names>Yumiko</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr3" contrib-type="author">
<name>
<surname>Maines</surname>
<given-names>Taronna R.</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr4" contrib-type="author">
<name>
<surname>Swayne</surname>
<given-names>David E.</given-names>
</name>
<xref ref-type="aff" rid="a3">
<sup>3</sup>
</xref>
</contrib>
<contrib id="cr5" contrib-type="author">
<name>
<surname>O’Neill</surname>
<given-names>Eduardo</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr6" contrib-type="author">
<name>
<surname>Davis</surname>
<given-names>C. Todd</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr7" contrib-type="author">
<name>
<surname>Van‐Hoven</surname>
<given-names>Neal</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr8" contrib-type="author">
<name>
<surname>Balish</surname>
<given-names>Amanda</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr9" contrib-type="author">
<name>
<surname>Yu</surname>
<given-names>Hong‐jie</given-names>
</name>
<xref ref-type="aff" rid="a1">
<sup>1</sup>
</xref>
</contrib>
<contrib id="cr10" contrib-type="author">
<name>
<surname>Katz</surname>
<given-names>Jacqueline M.</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr11" contrib-type="author">
<name>
<surname>Klimov</surname>
<given-names>Alexander</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr12" contrib-type="author">
<name>
<surname>Cox</surname>
<given-names>Nancy</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr13" contrib-type="author">
<name>
<surname>Li</surname>
<given-names>De‐xin</given-names>
</name>
<xref ref-type="aff" rid="a1">
<sup>1</sup>
</xref>
</contrib>
<contrib id="cr14" contrib-type="author">
<name>
<surname>Wang</surname>
<given-names>Yu</given-names>
</name>
<xref ref-type="aff" rid="a1">
<sup>1</sup>
</xref>
</contrib>
<contrib id="cr15" contrib-type="author">
<name>
<surname>Guo</surname>
<given-names>Yuan‐ji</given-names>
</name>
<xref ref-type="aff" rid="a1">
<sup>1</sup>
</xref>
</contrib>
<contrib id="cr16" contrib-type="author">
<name>
<surname>Yang</surname>
<given-names>Wei‐zhong</given-names>
</name>
<xref ref-type="aff" rid="a1">
<sup>1</sup>
</xref>
</contrib>
<contrib id="cr17" contrib-type="author">
<name>
<surname>Donis</surname>
<given-names>Ruben O.</given-names>
</name>
<xref ref-type="aff" rid="a2">
<sup>2</sup>
</xref>
</contrib>
<contrib id="cr18" contrib-type="author">
<name>
<surname>Shu</surname>
<given-names>Yue‐long</given-names>
</name>
<xref ref-type="aff" rid="a1">
<sup>1</sup>
</xref>
</contrib>
</contrib-group>
<aff id="a1">
<label>
<sup>1</sup>
</label>
Chinese National Influenza Center, State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Viral Disease Control and Prevention, China CDC, Xuanwu District Beijing, China</aff>
<aff id="a2">
<label>
<sup>2</sup>
</label>
Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA</aff>
<aff id="a3">
<label>
<sup>3</sup>
</label>
Southeast Poultry Research Laboratory, Agricultural Research Service, United States Department of Agriculture, Athens, GA, USA</aff>
<author-notes>
<corresp id="correspondenceTo">Dr. Ruben O. Donis, Influenza Division, NCIRD, CCID, Centers for Disease Control and Prevention, 1600 Clifton Road ‐ Mail Stop G‐16 Atlanta, GA 30333, USA. E‐mail:
<email>rdonis@cdc.gov</email>
</corresp>
</author-notes>
<pub-date pub-type="epub">
<day>22</day>
<month>10</month>
<year>2009</year>
</pub-date>
<pub-date pub-type="ppub">
<month>11</month>
<year>2009</year>
</pub-date>
<volume>3</volume>
<issue>6</issue>
<issue-id pub-id-type="doi">10.1111/irv.2009.3.issue-6</issue-id>
<fpage>287</fpage>
<lpage>295</lpage>
<history>Accepted 19 August 2009. Published Online 9 October 2009.</history>
<permissions>
<copyright-statement content-type="article-copyright">© 2009 Blackwell Publishing Ltd</copyright-statement>
</permissions>
<self-uri content-type="pdf" xlink:type="simple" xlink:href="file:IRV-3-287.pdf"></self-uri>
<abstract>
<p>
<bold>Background </bold>
Highly pathogenic H5N1 avian influenza viruses currently circulating in birds have caused hundreds of human infections, and pose a significant pandemic threat. Vaccines are a major component of the public health preparedness for this likely event. The rapid evolution of H5N1 viruses has resulted in the emergence of multiple clades with distinct antigenic characteristics that require clade‐specific vaccines. A variant H5N1 virus termed clade 2.3.4 emerged in 2005 and has caused multiple fatal infections. Vaccine candidates that match the antigenic properties of variant viruses are necessary because inactivated influenza vaccines elicit strain‐specific protection.</p>
<p>
<bold>Objective </bold>
To address the need for a suitable seed for manufacturing a clade 2.3.4 vaccine, we developed a new H5N1 pre‐pandemic candidate vaccine by reverse genetics and evaluated its safety and replication
<italic>in vitro</italic>
and
<italic>in vivo</italic>
.</p>
<p>
<bold>Methods </bold>
A reassortant virus termed, Anhui/PR8, was produced by reverse genetics in compliance with WHO pandemic vaccine development guidelines and contains six genes from A/Puerto Rico/8/34 as well as the neuraminidase and hemagglutinin (HA) genomic segments from the A/Anhui/01/2005 virus. The multi‐basic cleavage site of HA was removed to reduce virulence.</p>
<p>
<bold>Results </bold>
The reassortant Anhui/PR8 grows well in eggs and is avirulent to chicken and ferrets but retains the antigenicity of the parental A/Anhui/01/2005 virus.</p>
<p>
<bold>Conclusion </bold>
These results indicate that the Anhui/PR8 reassortant lost a major virulent determinant and it is suitable for its use in vaccine manufacturing and as a reference vaccine virus against the H5N1 clade 2.3.4 viruses circulating in eastern China, Vietnam, Thailand, and Laos.</p>
</abstract>
<kwd-group>
<kwd id="k1">Pandemic influenza</kwd>
<kwd id="k2">H5N1 vaccine</kwd>
<kwd id="k3">seed virus</kwd>
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