A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial
Identifieur interne : 000E61 ( Pmc/Checkpoint ); précédent : 000E60; suivant : 000E62A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial
Auteurs : Julie E. Martin [États-Unis] ; Mark K. Louder [États-Unis] ; Lasonji A. Holman [États-Unis] ; Ingelise J. Gordon [États-Unis] ; Mary E. Enama [États-Unis] ; Brenda D. Larkin [États-Unis] ; Charla A. Andrews [États-Unis] ; Leatrice Vogel [États-Unis] ; Richard A. Koup [États-Unis] ; Mario Roederer [États-Unis] ; Robert T. Bailer [États-Unis] ; Phillip L. Gomez [États-Unis] ; Martha Nason [États-Unis] ; John R. Mascola [États-Unis] ; Gary J. Nabel [États-Unis] ; Barney S. Graham [États-Unis]Source :
- Vaccine [ 0264-410X ] ; 2008.
Abstract
The severe acute respiratory syndrome (SARS) virus is a member of the
A single-plasmid DNA vaccine encoding the Spike (S) glycoprotein was evaluated in 10 healthy adults. Nine subjects completed the 3 dose vaccination schedule and were evaluated for vaccine safety and immune responses. Immune response was assessed by intracellular cytokine staining (ICS), ELISpot, ELISA, and neutralization assays.
The vaccine was well tolerated. SARS-CoV-specific antibody was detected by ELISA in 8 of 10 subjects and neutralizing antibody was detected in all subjects who received 3 doses of vaccine. SARS-CoV-specific CD4+ T-cell responses were detected in all vaccinees, and CD8+ T-cell responses in ∼20% of individuals.
The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.
Url:
DOI: 10.1016/j.vaccine.2008.09.026
PubMed: 18824060
PubMed Central: 2612543
Affiliations:
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial</title>
<author><name sortKey="Martin, Julie E" sort="Martin, Julie E" uniqKey="Martin J" first="Julie E." last="Martin">Julie E. Martin</name>
<affiliation wicri:level="2"><nlm:aff id="aff1">Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</nlm:aff>
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<author><name sortKey="Louder, Mark K" sort="Louder, Mark K" uniqKey="Louder M" first="Mark K." last="Louder">Mark K. Louder</name>
<affiliation wicri:level="2"><nlm:aff id="aff1">Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Holman, Lasonji A" sort="Holman, Lasonji A" uniqKey="Holman L" first="Lasonji A." last="Holman">Lasonji A. Holman</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Gordon, Ingelise J" sort="Gordon, Ingelise J" uniqKey="Gordon I" first="Ingelise J." last="Gordon">Ingelise J. Gordon</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Enama, Mary E" sort="Enama, Mary E" uniqKey="Enama M" first="Mary E." last="Enama">Mary E. Enama</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Larkin, Brenda D" sort="Larkin, Brenda D" uniqKey="Larkin B" first="Brenda D." last="Larkin">Brenda D. Larkin</name>
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<author><name sortKey="Andrews, Charla A" sort="Andrews, Charla A" uniqKey="Andrews C" first="Charla A." last="Andrews">Charla A. Andrews</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Vogel, Leatrice" sort="Vogel, Leatrice" uniqKey="Vogel L" first="Leatrice" last="Vogel">Leatrice Vogel</name>
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<author><name sortKey="Koup, Richard A" sort="Koup, Richard A" uniqKey="Koup R" first="Richard A." last="Koup">Richard A. Koup</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Roederer, Mario" sort="Roederer, Mario" uniqKey="Roederer M" first="Mario" last="Roederer">Mario Roederer</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017</wicri:regionArea>
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<author><name sortKey="Bailer, Robert T" sort="Bailer, Robert T" uniqKey="Bailer R" first="Robert T." last="Bailer">Robert T. Bailer</name>
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<country xml:lang="fr">États-Unis</country>
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<placeName><region type="state">Maryland</region>
</placeName>
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<author><name sortKey="Gomez, Phillip L" sort="Gomez, Phillip L" uniqKey="Gomez P" first="Phillip L." last="Gomez">Phillip L. Gomez</name>
<affiliation wicri:level="2"><nlm:aff id="aff1">Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
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<author><name sortKey="Nason, Martha" sort="Nason, Martha" uniqKey="Nason M" first="Martha" last="Nason">Martha Nason</name>
<affiliation wicri:level="2"><nlm:aff id="aff1">Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mascola, John R" sort="Mascola, John R" uniqKey="Mascola J" first="John R." last="Mascola">John R. Mascola</name>
<affiliation wicri:level="2"><nlm:aff id="aff1">Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nabel, Gary J" sort="Nabel, Gary J" uniqKey="Nabel G" first="Gary J." last="Nabel">Gary J. Nabel</name>
<affiliation wicri:level="2"><nlm:aff id="aff1">Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
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</affiliation>
</author>
<author><name sortKey="Graham, Barney S" sort="Graham, Barney S" uniqKey="Graham B" first="Barney S." last="Graham">Barney S. Graham</name>
<affiliation wicri:level="2"><nlm:aff id="aff1">Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
<idno type="eISSN">1873-2518</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>The severe acute respiratory syndrome (SARS) virus is a member of the <italic>Coronaviridae</italic>
(CoV) family that first appeared in the Guangdong Province of China in 2002 and was recognized as an emerging infectious disease in March 2003. Over 8000 cases and 900 deaths occurred during the epidemic. We report the safety and immunogenicity of a SARS DNA vaccine in a Phase I human study.</p>
</sec>
<sec><title>Methods</title>
<p>A single-plasmid DNA vaccine encoding the Spike (S) glycoprotein was evaluated in 10 healthy adults. Nine subjects completed the 3 dose vaccination schedule and were evaluated for vaccine safety and immune responses. Immune response was assessed by intracellular cytokine staining (ICS), ELISpot, ELISA, and neutralization assays.</p>
</sec>
<sec><title>Results</title>
<p>The vaccine was well tolerated. SARS-CoV-specific antibody was detected by ELISA in 8 of 10 subjects and neutralizing antibody was detected in all subjects who received 3 doses of vaccine. SARS-CoV-specific CD4+ T-cell responses were detected in all vaccinees, and CD8+ T-cell responses in ∼20% of individuals.</p>
</sec>
<sec><title>Conclusions</title>
<p>The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.</p>
</sec>
</div>
</front>
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</div1>
</back>
</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Vaccine</journal-id>
<journal-id journal-id-type="iso-abbrev">Vaccine</journal-id>
<journal-title-group><journal-title>Vaccine</journal-title>
</journal-title-group>
<issn pub-type="ppub">0264-410X</issn>
<issn pub-type="epub">1873-2518</issn>
<publisher><publisher-name>Elsevier Science</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">18824060</article-id>
<article-id pub-id-type="pmc">2612543</article-id>
<article-id pub-id-type="publisher-id">S0264-410X(08)01227-9</article-id>
<article-id pub-id-type="doi">10.1016/j.vaccine.2008.09.026</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Martin</surname>
<given-names>Julie E.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Louder</surname>
<given-names>Mark K.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Holman</surname>
<given-names>LaSonji A.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gordon</surname>
<given-names>Ingelise J.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Enama</surname>
<given-names>Mary E.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Larkin</surname>
<given-names>Brenda D.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Andrews</surname>
<given-names>Charla A.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Vogel</surname>
<given-names>Leatrice</given-names>
</name>
<xref rid="aff2" ref-type="aff">b</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Koup</surname>
<given-names>Richard A.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Roederer</surname>
<given-names>Mario</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bailer</surname>
<given-names>Robert T.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gomez</surname>
<given-names>Phillip L.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nason</surname>
<given-names>Martha</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mascola</surname>
<given-names>John R.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nabel</surname>
<given-names>Gary J.</given-names>
</name>
<xref rid="aff1" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Graham</surname>
<given-names>Barney S.</given-names>
</name>
<email>bgraham@mail.nih.gov</email>
<xref rid="aff1" ref-type="aff">a</xref>
<xref rid="cor1" ref-type="corresp">⁎</xref>
</contrib>
<contrib contrib-type="author"><collab>the VRC 301 Study Team</collab>
<xref rid="fn1" ref-type="fn">1</xref>
</contrib>
</contrib-group>
<aff id="aff1"><label>a</label>
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610, Bethesda, MD 20892-3017, USA</aff>
<aff id="aff2"><label>b</label>
Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 33 North Drive, Bethesda, MD 20892-3203, USA</aff>
<author-notes><corresp id="cor1"><label>⁎</label>
Corresponding author. Tel.: +1 301 594 8468; fax: +1 301 480 2771. <email>bgraham@mail.nih.gov</email>
</corresp>
<fn id="fn1"><label>1</label>
<p>The VRC 301 Study Team includes Margaret McCluskey, Sarah Hubka, Steve Rucker, Laura Novik, Pamela Edmonds, LaChonne Stanford, Woody Dubois, Tiffany Alley, Erica Eaton, Sandra Sitar, Ericka Thompson, Andrew Catanzaro, Joseph Casazza, Laurence Lemiale, and Rebecca Sheets.</p>
</fn>
</author-notes>
<pub-date pub-type="pmc-release"><day>26</day>
<month>9</month>
<year>2008</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="ppub"><day>25</day>
<month>11</month>
<year>2008</year>
</pub-date>
<pub-date pub-type="epub"><day>26</day>
<month>9</month>
<year>2008</year>
</pub-date>
<volume>26</volume>
<issue>50</issue>
<fpage>6338</fpage>
<lpage>6343</lpage>
<history><date date-type="received"><day>24</day>
<month>3</month>
<year>2008</year>
</date>
<date date-type="rev-recd"><day>14</day>
<month>8</month>
<year>2008</year>
</date>
<date date-type="accepted"><day>2</day>
<month>9</month>
<year>2008</year>
</date>
</history>
<permissions><license><license-p>Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.</license-p>
</license>
</permissions>
<abstract><sec><title>Background</title>
<p>The severe acute respiratory syndrome (SARS) virus is a member of the <italic>Coronaviridae</italic>
(CoV) family that first appeared in the Guangdong Province of China in 2002 and was recognized as an emerging infectious disease in March 2003. Over 8000 cases and 900 deaths occurred during the epidemic. We report the safety and immunogenicity of a SARS DNA vaccine in a Phase I human study.</p>
</sec>
<sec><title>Methods</title>
<p>A single-plasmid DNA vaccine encoding the Spike (S) glycoprotein was evaluated in 10 healthy adults. Nine subjects completed the 3 dose vaccination schedule and were evaluated for vaccine safety and immune responses. Immune response was assessed by intracellular cytokine staining (ICS), ELISpot, ELISA, and neutralization assays.</p>
</sec>
<sec><title>Results</title>
<p>The vaccine was well tolerated. SARS-CoV-specific antibody was detected by ELISA in 8 of 10 subjects and neutralizing antibody was detected in all subjects who received 3 doses of vaccine. SARS-CoV-specific CD4+ T-cell responses were detected in all vaccinees, and CD8+ T-cell responses in ∼20% of individuals.</p>
</sec>
<sec><title>Conclusions</title>
<p>The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.</p>
</sec>
</abstract>
<kwd-group><title>Keywords</title>
<kwd>T-cell vaccine</kwd>
<kwd>Emerging infectious disease</kwd>
<kwd>Vaccine clinical trial</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Maryland</li>
</region>
</list>
<tree><country name="États-Unis"><region name="Maryland"><name sortKey="Martin, Julie E" sort="Martin, Julie E" uniqKey="Martin J" first="Julie E." last="Martin">Julie E. Martin</name>
</region>
<name sortKey="Andrews, Charla A" sort="Andrews, Charla A" uniqKey="Andrews C" first="Charla A." last="Andrews">Charla A. Andrews</name>
<name sortKey="Bailer, Robert T" sort="Bailer, Robert T" uniqKey="Bailer R" first="Robert T." last="Bailer">Robert T. Bailer</name>
<name sortKey="Enama, Mary E" sort="Enama, Mary E" uniqKey="Enama M" first="Mary E." last="Enama">Mary E. Enama</name>
<name sortKey="Gomez, Phillip L" sort="Gomez, Phillip L" uniqKey="Gomez P" first="Phillip L." last="Gomez">Phillip L. Gomez</name>
<name sortKey="Gordon, Ingelise J" sort="Gordon, Ingelise J" uniqKey="Gordon I" first="Ingelise J." last="Gordon">Ingelise J. Gordon</name>
<name sortKey="Graham, Barney S" sort="Graham, Barney S" uniqKey="Graham B" first="Barney S." last="Graham">Barney S. Graham</name>
<name sortKey="Holman, Lasonji A" sort="Holman, Lasonji A" uniqKey="Holman L" first="Lasonji A." last="Holman">Lasonji A. Holman</name>
<name sortKey="Koup, Richard A" sort="Koup, Richard A" uniqKey="Koup R" first="Richard A." last="Koup">Richard A. Koup</name>
<name sortKey="Larkin, Brenda D" sort="Larkin, Brenda D" uniqKey="Larkin B" first="Brenda D." last="Larkin">Brenda D. Larkin</name>
<name sortKey="Louder, Mark K" sort="Louder, Mark K" uniqKey="Louder M" first="Mark K." last="Louder">Mark K. Louder</name>
<name sortKey="Mascola, John R" sort="Mascola, John R" uniqKey="Mascola J" first="John R." last="Mascola">John R. Mascola</name>
<name sortKey="Nabel, Gary J" sort="Nabel, Gary J" uniqKey="Nabel G" first="Gary J." last="Nabel">Gary J. Nabel</name>
<name sortKey="Nason, Martha" sort="Nason, Martha" uniqKey="Nason M" first="Martha" last="Nason">Martha Nason</name>
<name sortKey="Roederer, Mario" sort="Roederer, Mario" uniqKey="Roederer M" first="Mario" last="Roederer">Mario Roederer</name>
<name sortKey="Vogel, Leatrice" sort="Vogel, Leatrice" uniqKey="Vogel L" first="Leatrice" last="Vogel">Leatrice Vogel</name>
</country>
</tree>
</affiliations>
</record>
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