SrasV1, PascalFrancis, Corpus, bibRecord, 000238

A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial

Identifieur interne : 000238 ( PascalFrancis/Corpus ); précédent : 000237; suivant : 000239

A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial

Auteurs : Julie E. Martin ; Mark K. Louder ; Lasonji A. Holman ; Ingelise J. Gordon ; Mary E. Enama ; Brenda D. Larkin ; Charla A. Andrews ; Leatrice Vogel ; Richard A. Koup ; Mario Roederer ; Robert T. Bailer ; Phillip L. Gomez ; Martha Nason ; John R. Mascola ; Gary J. Nabel ; Barney S. Graham

Source :

Vaccine [ 0264-410X ] ; 2008.

RBID : Pascal:09-0039744

Descripteurs français

Pascal (Inist)
- Vaccin génétique, Anticorps neutralisant, Immunité humorale, Réponse immune, Immunité cellulaire, Essai clinique phase I, Lymphocyte T, Essai clinique, Maladie émergente, Infection.

English descriptors

KwdEn :
- Cellular immunity, Clinical trial, Emerging disease, Genetic vaccine, Humoral immunity, Immune response, Infection, Neutralizing antibody, Phase I trial, T-Lymphocyte.

Abstract

Background: The severe acute respiratory syndrome (SARS) virus is a member of the Coronaviridae (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. Methods: 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. Results: 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. Conclusions: The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08	`01`	`1`	`ENG`	`@1 A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial`
A11	`01`	`1`		`@1 MARTIN (Julie E.)`
A11	`02`	`1`		`@1 LOUDER (Mark K.)`
A11	`03`	`1`		`@1 HOLMAN (Lasonji A.)`
A11	`04`	`1`		`@1 GORDON (Ingelise J.)`
A11	`05`	`1`		`@1 ENAMA (Mary E.)`
A11	`06`	`1`		`@1 LARKIN (Brenda D.)`
A11	`07`	`1`		`@1 ANDREWS (Charla A.)`
A11	`08`	`1`		`@1 VOGEL (Leatrice)`
A11	`09`	`1`		`@1 KOUP (Richard A.)`
A11	`10`	`1`		`@1 ROEDERER (Mario)`
A11	`11`	`1`		`@1 BAILER (Robert T.)`
A11	`12`	`1`		`@1 GOMEZ (Phillip L.)`
A11	`13`	`1`		`@1 NASON (Martha)`
A11	`14`	`1`		`@1 MASCOLA (John R.)`
A11	`15`	`1`		`@1 NABEL (Gary J.)`
A11	`16`	`1`		`@1 GRAHAM (Barney S.)`
A14	`01`			`@1 Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610 @2 Bethesda, MD 20892-3017 @3 USA @Z 1 aut. @Z 2 aut. @Z 3 aut. @Z 4 aut. @Z 5 aut. @Z 6 aut. @Z 7 aut. @Z 9 aut. @Z 10 aut. @Z 11 aut. @Z 12 aut. @Z 13 aut. @Z 14 aut. @Z 15 aut. @Z 16 aut.`
A14	`02`			`@1 Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 33 North Drive @2 Bethesda, MD 20892-3203 @3 USA @Z 8 aut.`
A17	`01`	`1`		`@1 VRC 301 Study Team @3 INC`
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A44				`@0 0000 @1 © 2009 INIST-CNRS. All rights reserved.`
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C01	`01`		`ENG`	@0 Background: The severe acute respiratory syndrome (SARS) virus is a member of the Coronaviridae (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. Methods: 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. Results: 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. Conclusions: The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.
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C03	`01`	`X`	`ENG`	`@0 Genetic vaccine @5 05`
C03	`01`	`X`	`SPA`	`@0 Vacuna genética @5 05`
C03	`02`	`X`	`FRE`	`@0 Anticorps neutralisant @5 06`
C03	`02`	`X`	`ENG`	`@0 Neutralizing antibody @5 06`
C03	`02`	`X`	`SPA`	`@0 anticuerpo neutralizante @5 06`
C03	`03`	`X`	`FRE`	`@0 Immunité humorale @5 07`
C03	`03`	`X`	`ENG`	`@0 Humoral immunity @5 07`
C03	`03`	`X`	`SPA`	`@0 Inmunidad humoral @5 07`
C03	`04`	`X`	`FRE`	`@0 Réponse immune @5 08`
C03	`04`	`X`	`ENG`	`@0 Immune response @5 08`
C03	`04`	`X`	`SPA`	`@0 Respuesta inmune @5 08`
C03	`05`	`X`	`FRE`	`@0 Immunité cellulaire @5 09`
C03	`05`	`X`	`ENG`	`@0 Cellular immunity @5 09`
C03	`05`	`X`	`SPA`	`@0 Inmunidad celular @5 09`
C03	`06`	`X`	`FRE`	`@0 Essai clinique phase I @5 10`
C03	`06`	`X`	`ENG`	`@0 Phase I trial @5 10`
C03	`06`	`X`	`SPA`	`@0 Ensayo clínico fase I @5 10`
C03	`07`	`X`	`FRE`	`@0 Lymphocyte T @5 11`
C03	`07`	`X`	`ENG`	`@0 T-Lymphocyte @5 11`
C03	`07`	`X`	`SPA`	`@0 Linfocito T @5 11`
C03	`08`	`X`	`FRE`	`@0 Essai clinique @5 12`
C03	`08`	`X`	`ENG`	`@0 Clinical trial @5 12`
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N44	`01`			`@1 OTO`
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Format Inist (serveur)

NO :	PASCAL 09-0039744 INIST
ET :	A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial
AU :	MARTIN (Julie E.); LOUDER (Mark K.); HOLMAN (Lasonji A.); GORDON (Ingelise J.); ENAMA (Mary E.); LARKIN (Brenda D.); ANDREWS (Charla A.); VOGEL (Leatrice); KOUP (Richard A.); ROEDERER (Mario); BAILER (Robert T.); GOMEZ (Phillip L.); NASON (Martha); MASCOLA (John R.); NABEL (Gary J.); GRAHAM (Barney S.)
AF :	Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610/Bethesda, MD 20892-3017/Etats-Unis (1 aut., 2 aut., 3 aut., 4 aut., 5 aut., 6 aut., 7 aut., 9 aut., 10 aut., 11 aut., 12 aut., 13 aut., 14 aut., 15 aut., 16 aut.); Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 33 North Drive/Bethesda, MD 20892-3203/Etats-Unis (8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2008; Vol. 26; No. 50; Pp. 6338-6343; Bibl. 28 ref.
LA :	Anglais
EA :	Background: The severe acute respiratory syndrome (SARS) virus is a member of the Coronaviridae (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. Methods: 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. Results: 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. Conclusions: The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.
CC :	002A05F04
FD :	Vaccin génétique; Anticorps neutralisant; Immunité humorale; Réponse immune; Immunité cellulaire; Essai clinique phase I; Lymphocyte T; Essai clinique; Maladie émergente; Infection
ED :	Genetic vaccine; Neutralizing antibody; Humoral immunity; Immune response; Cellular immunity; Phase I trial; T-Lymphocyte; Clinical trial; Emerging disease; Infection
SD :	Vacuna genética; anticuerpo neutralizante; Inmunidad humoral; Respuesta inmune; Inmunidad celular; Ensayo clínico fase I; Linfocito T; Ensayo clínico; Enfermedad emergente; Infección
LO :	INIST-20289.354000196098910070
ID :	09-0039744

Links to Exploration step

Pascal:09-0039744

Le document en format XML

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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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<author><name sortKey="Roederer, Mario" sort="Roederer, Mario" uniqKey="Roederer M" first="Mario" last="Roederer">Mario Roederer</name>
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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>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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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><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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<author><name sortKey="Nason, Martha" sort="Nason, Martha" uniqKey="Nason M" first="Martha" last="Nason">Martha Nason</name>
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<author><name sortKey="Mascola, John R" sort="Mascola, John R" uniqKey="Mascola J" first="John R." last="Mascola">John R. Mascola</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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<author><name sortKey="Graham, Barney S" sort="Graham, Barney S" uniqKey="Graham B" first="Barney S." last="Graham">Barney S. Graham</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">09-0039744</idno>
<date when="2008">2008</date>
<idno type="stanalyst">PASCAL 09-0039744 INIST</idno>
<idno type="RBID">Pascal:09-0039744</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000238</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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</author>
<author><name sortKey="Louder, Mark K" sort="Louder, Mark K" uniqKey="Louder M" first="Mark K." last="Louder">Mark K. Louder</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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</affiliation>
</author>
<author><name sortKey="Holman, Lasonji A" sort="Holman, Lasonji A" uniqKey="Holman L" first="Lasonji A." last="Holman">Lasonji A. Holman</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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</affiliation>
</author>
<author><name sortKey="Gordon, Ingelise J" sort="Gordon, Ingelise J" uniqKey="Gordon I" first="Ingelise J." last="Gordon">Ingelise J. Gordon</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
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</affiliation>
</author>
<author><name sortKey="Enama, Mary E" sort="Enama, Mary E" uniqKey="Enama M" first="Mary E." last="Enama">Mary E. Enama</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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</affiliation>
</author>
<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>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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</author>
<author><name sortKey="Vogel, Leatrice" sort="Vogel, Leatrice" uniqKey="Vogel L" first="Leatrice" last="Vogel">Leatrice Vogel</name>
<affiliation><inist:fA14 i1="02"><s1>Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 33 North Drive</s1>
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</affiliation>
</author>
<author><name sortKey="Koup, Richard A" sort="Koup, Richard A" uniqKey="Koup R" first="Richard A." last="Koup">Richard A. Koup</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
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</affiliation>
</author>
<author><name sortKey="Roederer, Mario" sort="Roederer, Mario" uniqKey="Roederer M" first="Mario" last="Roederer">Mario Roederer</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
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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>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
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</author>
<author><name sortKey="Gomez, Phillip L" sort="Gomez, Phillip L" uniqKey="Gomez P" first="Phillip L." last="Gomez">Phillip L. Gomez</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
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<author><name sortKey="Nason, Martha" sort="Nason, Martha" uniqKey="Nason M" first="Martha" last="Nason">Martha Nason</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
<s3>USA</s3>
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</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><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
<s3>USA</s3>
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<author><name sortKey="Nabel, Gary J" sort="Nabel, Gary J" uniqKey="Nabel G" first="Gary J." last="Nabel">Gary J. Nabel</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
<s3>USA</s3>
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</author>
<author><name sortKey="Graham, Barney S" sort="Graham, Barney S" uniqKey="Graham B" first="Barney S." last="Graham">Barney S. Graham</name>
<affiliation><inist:fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
<s3>USA</s3>
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</author>
</analytic>
<series><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cellular immunity</term>
<term>Clinical trial</term>
<term>Emerging disease</term>
<term>Genetic vaccine</term>
<term>Humoral immunity</term>
<term>Immune response</term>
<term>Infection</term>
<term>Neutralizing antibody</term>
<term>Phase I trial</term>
<term>T-Lymphocyte</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Vaccin génétique</term>
<term>Anticorps neutralisant</term>
<term>Immunité humorale</term>
<term>Réponse immune</term>
<term>Immunité cellulaire</term>
<term>Essai clinique phase I</term>
<term>Lymphocyte T</term>
<term>Essai clinique</term>
<term>Maladie émergente</term>
<term>Infection</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background: The severe acute respiratory syndrome (SARS) virus is a member of the Coronaviridae (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. Methods: 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. Results: 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. Conclusions: The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0264-410X</s0>
</fA01>
<fA02 i1="01"><s0>VACCDE</s0>
</fA02>
<fA03 i2="1"><s0>Vaccine</s0>
</fA03>
<fA05><s2>26</s2>
</fA05>
<fA06><s2>50</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>MARTIN (Julie E.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>LOUDER (Mark K.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>HOLMAN (Lasonji A.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>GORDON (Ingelise J.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>ENAMA (Mary E.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>LARKIN (Brenda D.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>ANDREWS (Charla A.)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>VOGEL (Leatrice)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>KOUP (Richard A.)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>ROEDERER (Mario)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>BAILER (Robert T.)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>GOMEZ (Phillip L.)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>NASON (Martha)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>MASCOLA (John R.)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>NABEL (Gary J.)</s1>
</fA11>
<fA11 i1="16" i2="1"><s1>GRAHAM (Barney S.)</s1>
</fA11>
<fA14 i1="01"><s1>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610</s1>
<s2>Bethesda, MD 20892-3017</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
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<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 33 North Drive</s1>
<s2>Bethesda, MD 20892-3203</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>VRC 301 Study Team</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>6338-6343</s1>
</fA20>
<fA21><s1>2008</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20289</s2>
<s5>354000196098910070</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2009 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>28 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>09-0039744</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Vaccine</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Background: The severe acute respiratory syndrome (SARS) virus is a member of the Coronaviridae (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. Methods: 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. Results: 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. Conclusions: The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002A05F04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Vaccin génétique</s0>
<s5>05</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Genetic vaccine</s0>
<s5>05</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Vacuna genética</s0>
<s5>05</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Anticorps neutralisant</s0>
<s5>06</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Neutralizing antibody</s0>
<s5>06</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>anticuerpo neutralizante</s0>
<s5>06</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Immunité humorale</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Humoral immunity</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Inmunidad humoral</s0>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Réponse immune</s0>
<s5>08</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Immune response</s0>
<s5>08</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Respuesta inmune</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Immunité cellulaire</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Cellular immunity</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Inmunidad celular</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Essai clinique phase I</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Phase I trial</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Ensayo clínico fase I</s0>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Lymphocyte T</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>T-Lymphocyte</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Linfocito T</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Essai clinique</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Clinical trial</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Ensayo clínico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Maladie émergente</s0>
<s2>NM</s2>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Emerging disease</s0>
<s2>NM</s2>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Enfermedad emergente</s0>
<s2>NM</s2>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Infection</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Infection</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Infección</s0>
<s5>15</s5>
</fC03>
<fN21><s1>026</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 09-0039744 INIST</NO>
<ET>A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial</ET>
<AU>MARTIN (Julie E.); LOUDER (Mark K.); HOLMAN (Lasonji A.); GORDON (Ingelise J.); ENAMA (Mary E.); LARKIN (Brenda D.); ANDREWS (Charla A.); VOGEL (Leatrice); KOUP (Richard A.); ROEDERER (Mario); BAILER (Robert T.); GOMEZ (Phillip L.); NASON (Martha); MASCOLA (John R.); NABEL (Gary J.); GRAHAM (Barney S.)</AU>
<AF>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, MSC-2610/Bethesda, MD 20892-3017/Etats-Unis (1 aut., 2 aut., 3 aut., 4 aut., 5 aut., 6 aut., 7 aut., 9 aut., 10 aut., 11 aut., 12 aut., 13 aut., 14 aut., 15 aut., 16 aut.); Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 33 North Drive/Bethesda, MD 20892-3203/Etats-Unis (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2008; Vol. 26; No. 50; Pp. 6338-6343; Bibl. 28 ref.</SO>
<LA>Anglais</LA>
<EA>Background: The severe acute respiratory syndrome (SARS) virus is a member of the Coronaviridae (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. Methods: 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. Results: 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. Conclusions: The VRC SARS DNA vaccine was well tolerated and produced cellular immune responses and neutralizing antibody in healthy adults.</EA>
<CC>002A05F04</CC>
<FD>Vaccin génétique; Anticorps neutralisant; Immunité humorale; Réponse immune; Immunité cellulaire; Essai clinique phase I; Lymphocyte T; Essai clinique; Maladie émergente; Infection</FD>
<ED>Genetic vaccine; Neutralizing antibody; Humoral immunity; Immune response; Cellular immunity; Phase I trial; T-Lymphocyte; Clinical trial; Emerging disease; Infection</ED>
<SD>Vacuna genética; anticuerpo neutralizante; Inmunidad humoral; Respuesta inmune; Inmunidad celular; Ensayo clínico fase I; Linfocito T; Ensayo clínico; Enfermedad emergente; Infección</SD>
<LO>INIST-20289.354000196098910070</LO>
<ID>09-0039744</ID>
</server>
</inist>
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A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial

A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial

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