Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.
Identifieur interne : 002288 ( Ncbi/Merge ); précédent : 002287; suivant : 002289Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.
Auteurs : Kayvon Modjarrad [États-Unis] ; Christine C. Roberts [Corée du Sud] ; Kristin T. Mills [États-Unis] ; Amy R. Castellano [États-Unis] ; Kristopher Paolino [États-Unis] ; Kar Muthumani [États-Unis] ; Emma L. Reuschel [États-Unis] ; Merlin L. Robb [États-Unis] ; Trina Racine [Canada] ; Myoung-Don Oh [Corée du Sud] ; Claude Lamarre [Canada] ; Faraz I. Zaidi [États-Unis] ; Jean Boyer [États-Unis] ; Sagar B. Kudchodkar [Corée du Sud] ; Moonsup Jeong [Corée du Sud] ; Janice M. Darden [États-Unis] ; Young K. Park [Corée du Sud] ; Paul T. Scott [États-Unis] ; Celine Remigio [Corée du Sud] ; Ajay P. Parikh [États-Unis] ; Megan C. Wise [États-Unis] ; Ami Patel [États-Unis] ; Elizabeth K. Duperret [États-Unis] ; Kevin Y. Kim [États-Unis] ; Hyeree Choi [États-Unis] ; Scott White [États-Unis] ; Mark Bagarazzi [États-Unis] ; Jeanine M. May [États-Unis] ; Deborah Kane [Corée du Sud] ; Hyojin Lee [Corée du Sud] ; Gary Kobinger [Canada] ; Nelson L. Michael [États-Unis] ; David B. Weiner [États-Unis] ; Stephen J. Thomas [États-Unis] ; Joel N. Maslow [Corée du Sud]Source :
- The Lancet. Infectious diseases [ 1474-4457 ] ; 2019.
Abstract
Middle East respiratory syndrome (MERS) coronavirus causes a highly fatal lower-respiratory tract infection. There are as yet no licensed MERS vaccines or therapeutics. This study (WRAIR-2274) assessed the safety, tolerability, and immunogenicity of the GLS-5300 MERS coronavirus DNA vaccine in healthy adults.
DOI: 10.1016/S1473-3099(19)30266-X
PubMed: 31351922
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Michael</name><affiliation wicri:level="2"><nlm:affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Walter Reed Army Institute for Research, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Weiner, David B" sort="Weiner, David B" uniqKey="Weiner D" first="David B" last="Weiner">David B. Weiner</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Thomas, Stephen J" sort="Thomas, Stephen J" uniqKey="Thomas S" first="Stephen J" last="Thomas">Stephen J. Thomas</name><affiliation wicri:level="2"><nlm:affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Walter Reed Army Institute for Research, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Maslow, Joel N" sort="Maslow, Joel N" uniqKey="Maslow J" first="Joel N" last="Maslow">Joel N. Maslow</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2019">2019</date><idno type="RBID">pubmed:31351922</idno><idno type="pmid">31351922</idno><idno type="doi">10.1016/S1473-3099(19)30266-X</idno><idno type="wicri:Area/PubMed/Corpus">000471</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000471</idno><idno type="wicri:Area/PubMed/Curation">000471</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000471</idno><idno type="wicri:Area/PubMed/Checkpoint">000393</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000393</idno><idno type="wicri:Area/Ncbi/Merge">002288</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.</title><author><name sortKey="Modjarrad, Kayvon" sort="Modjarrad, Kayvon" uniqKey="Modjarrad K" first="Kayvon" last="Modjarrad">Kayvon Modjarrad</name><affiliation wicri:level="2"><nlm:affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Walter Reed Army Institute for Research, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Roberts, Christine C" sort="Roberts, Christine C" uniqKey="Roberts C" first="Christine C" last="Roberts">Christine C. Roberts</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea. Electronic address: croberts@geneonels-us.com.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Mills, Kristin T" sort="Mills, Kristin T" uniqKey="Mills K" first="Kristin T" last="Mills">Kristin T. Mills</name><affiliation wicri:level="2"><nlm:affiliation>ICON Clinical Research Management, Gaithersburg, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>ICON Clinical Research Management, Gaithersburg, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Castellano, Amy R" sort="Castellano, Amy R" uniqKey="Castellano A" first="Amy R" last="Castellano">Amy R. Castellano</name><affiliation wicri:level="2"><nlm:affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Paolino, Kristopher" sort="Paolino, Kristopher" uniqKey="Paolino K" first="Kristopher" last="Paolino">Kristopher Paolino</name><affiliation wicri:level="2"><nlm:affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Walter Reed Army Institute for Research, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Muthumani, Kar" sort="Muthumani, Kar" uniqKey="Muthumani K" first="Kar" last="Muthumani">Kar Muthumani</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Reuschel, Emma L" sort="Reuschel, Emma L" uniqKey="Reuschel E" first="Emma L" last="Reuschel">Emma L. Reuschel</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Robb, Merlin L" sort="Robb, Merlin L" uniqKey="Robb M" first="Merlin L" last="Robb">Merlin L. Robb</name><affiliation wicri:level="2"><nlm:affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Racine, Trina" sort="Racine, Trina" uniqKey="Racine T" first="Trina" last="Racine">Trina Racine</name><affiliation wicri:level="1"><nlm:affiliation>Université Laval, Quebec City, QC, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Université Laval, Quebec City, QC</wicri:regionArea><wicri:noRegion>QC</wicri:noRegion></affiliation></author><author><name sortKey="Oh, Myoung Don" sort="Oh, Myoung Don" uniqKey="Oh M" first="Myoung-Don" last="Oh">Myoung-Don Oh</name><affiliation wicri:level="3"><nlm:affiliation>Seoul National University College of Medicine, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Seoul National University College of Medicine, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Lamarre, Claude" sort="Lamarre, Claude" uniqKey="Lamarre C" first="Claude" last="Lamarre">Claude Lamarre</name><affiliation wicri:level="1"><nlm:affiliation>Université Laval, Quebec City, QC, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Université Laval, Quebec City, QC</wicri:regionArea><wicri:noRegion>QC</wicri:noRegion></affiliation></author><author><name sortKey="Zaidi, Faraz I" sort="Zaidi, Faraz I" uniqKey="Zaidi F" first="Faraz I" last="Zaidi">Faraz I. Zaidi</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Boyer, Jean" sort="Boyer, Jean" uniqKey="Boyer J" first="Jean" last="Boyer">Jean Boyer</name><affiliation wicri:level="2"><nlm:affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Inovio Pharmaceuticals, Plymouth Meeting, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Kudchodkar, Sagar B" sort="Kudchodkar, Sagar B" uniqKey="Kudchodkar S" first="Sagar B" last="Kudchodkar">Sagar B. Kudchodkar</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Jeong, Moonsup" sort="Jeong, Moonsup" uniqKey="Jeong M" first="Moonsup" last="Jeong">Moonsup Jeong</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Darden, Janice M" sort="Darden, Janice M" uniqKey="Darden J" first="Janice M" last="Darden">Janice M. Darden</name><affiliation wicri:level="2"><nlm:affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Park, Young K" sort="Park, Young K" uniqKey="Park Y" first="Young K" last="Park">Young K. Park</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Scott, Paul T" sort="Scott, Paul T" uniqKey="Scott P" first="Paul T" last="Scott">Paul T. Scott</name><affiliation wicri:level="2"><nlm:affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Walter Reed Army Institute for Research, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Remigio, Celine" sort="Remigio, Celine" uniqKey="Remigio C" first="Celine" last="Remigio">Celine Remigio</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Parikh, Ajay P" sort="Parikh, Ajay P" uniqKey="Parikh A" first="Ajay P" last="Parikh">Ajay P. Parikh</name><affiliation wicri:level="2"><nlm:affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Wise, Megan C" sort="Wise, Megan C" uniqKey="Wise M" first="Megan C" last="Wise">Megan C. Wise</name><affiliation wicri:level="2"><nlm:affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Inovio Pharmaceuticals, Plymouth Meeting, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Patel, Ami" sort="Patel, Ami" uniqKey="Patel A" first="Ami" last="Patel">Ami Patel</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Duperret, Elizabeth K" sort="Duperret, Elizabeth K" uniqKey="Duperret E" first="Elizabeth K" last="Duperret">Elizabeth K. Duperret</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Kim, Kevin Y" sort="Kim, Kevin Y" uniqKey="Kim K" first="Kevin Y" last="Kim">Kevin Y. Kim</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Choi, Hyeree" sort="Choi, Hyeree" uniqKey="Choi H" first="Hyeree" last="Choi">Hyeree Choi</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="White, Scott" sort="White, Scott" uniqKey="White S" first="Scott" last="White">Scott White</name><affiliation wicri:level="2"><nlm:affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Inovio Pharmaceuticals, Plymouth Meeting, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Bagarazzi, Mark" sort="Bagarazzi, Mark" uniqKey="Bagarazzi M" first="Mark" last="Bagarazzi">Mark Bagarazzi</name><affiliation wicri:level="2"><nlm:affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Inovio Pharmaceuticals, Plymouth Meeting, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="May, Jeanine M" sort="May, Jeanine M" uniqKey="May J" first="Jeanine M" last="May">Jeanine M. May</name><affiliation wicri:level="2"><nlm:affiliation>Emmes Corporation, Rockville, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Emmes Corporation, Rockville, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Kane, Deborah" sort="Kane, Deborah" uniqKey="Kane D" first="Deborah" last="Kane">Deborah Kane</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Lee, Hyojin" sort="Lee, Hyojin" uniqKey="Lee H" first="Hyojin" last="Lee">Hyojin Lee</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Kobinger, Gary" sort="Kobinger, Gary" uniqKey="Kobinger G" first="Gary" last="Kobinger">Gary Kobinger</name><affiliation wicri:level="1"><nlm:affiliation>Université Laval, Quebec City, QC, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Université Laval, Quebec City, QC</wicri:regionArea><wicri:noRegion>QC</wicri:noRegion></affiliation></author><author><name sortKey="Michael, Nelson L" sort="Michael, Nelson L" uniqKey="Michael N" first="Nelson L" last="Michael">Nelson L. Michael</name><affiliation wicri:level="2"><nlm:affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Walter Reed Army Institute for Research, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Weiner, David B" sort="Weiner, David B" uniqKey="Weiner D" first="David B" last="Weiner">David B. Weiner</name><affiliation wicri:level="2"><nlm:affiliation>Wistar Institute, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wistar Institute, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Thomas, Stephen J" sort="Thomas, Stephen J" uniqKey="Thomas S" first="Stephen J" last="Thomas">Stephen J. Thomas</name><affiliation wicri:level="2"><nlm:affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Walter Reed Army Institute for Research, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Maslow, Joel N" sort="Maslow, Joel N" uniqKey="Maslow J" first="Joel N" last="Maslow">Joel N. Maslow</name><affiliation wicri:level="3"><nlm:affiliation>GeneOne Life Science, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>GeneOne Life Science, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author></analytic><series><title level="j">The Lancet. Infectious diseases</title><idno type="eISSN">1474-4457</idno><imprint><date when="2019" type="published">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Middle East respiratory syndrome (MERS) coronavirus causes a highly fatal lower-respiratory tract infection. There are as yet no licensed MERS vaccines or therapeutics. This study (WRAIR-2274) assessed the safety, tolerability, and immunogenicity of the GLS-5300 MERS coronavirus DNA vaccine in healthy adults.</div></front></TEI><pubmed><MedlineCitation Status="In-Data-Review" Owner="NLM"><PMID Version="1">31351922</PMID><DateRevised><Year>2019</Year><Month>09</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4457</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>9</Issue><PubDate><Year>2019</Year><Month>Sep</Month></PubDate></JournalIssue><Title>The Lancet. Infectious diseases</Title><ISOAbbreviation>Lancet Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.</ArticleTitle><Pagination><MedlinePgn>1013-1022</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1473-3099(19)30266-X</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1473-3099(19)30266-X</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Middle East respiratory syndrome (MERS) coronavirus causes a highly fatal lower-respiratory tract infection. There are as yet no licensed MERS vaccines or therapeutics. This study (WRAIR-2274) assessed the safety, tolerability, and immunogenicity of the GLS-5300 MERS coronavirus DNA vaccine in healthy adults.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This study was a phase 1, open-label, single-arm, dose-escalation study of GLS-5300 done at the Walter Reed Army Institute for Research Clinical Trials Center (Silver Spring, MD, USA). We enrolled healthy adults aged 18-50 years; exclusion criteria included previous infection or treatment of MERS. Eligible participants were enrolled sequentially using a dose-escalation protocol to receive 0·67 mg, 2 mg, or 6 mg GLS-5300 administered by trained clinical site staff via a single intramuscular 1 mL injection at each vaccination at baseline, week 4, and week 12 followed immediately by co-localised intramuscular electroporation. Enrolment into the higher dose groups occurred after a safety monitoring committee reviewed the data following vaccination of the first five participants at the previous lower dose in each group. The primary outcome of the study was safety, assessed in all participants who received at least one study treatment and for whom post-dose study data were available, during the vaccination period with follow-up through to 48 weeks after dose 3. Safety was measured by the incidence of adverse events; administration site reactions and pain; and changes in safety laboratory parameters. The secondary outcome was immunogenicity. This trial is registered at ClinicalTrials.gov (number NCT02670187) and is completed.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Feb 17 and July 22, 2016, we enrolled 75 individuals and allocated 25 each to 0·67 mg, 2 mg, or 6 mg GLS-5300. No vaccine-associated serious adverse events were reported. The most common adverse events were injection-site reactions, reported in 70 participants (93%) of 75. Overall, 73 participants (97%) of 75 reported at least one solicited adverse event; the most common systemic symptoms were headache (five [20%] with 0·67 mg, 11 [44%] with 2 mg, and seven [28%] with 6 mg), and malaise or fatigue (five [20%] with 0·67 mg, seven [28%] with 2 mg, and two [8%] with 6 mg). The most common local solicited symptoms were administration site pain (23 [92%] with all three doses) and tenderness (21 [84%] with all three doses). Most solicited symptoms were reported as mild (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg) and were self-limiting. Unsolicited symptoms were reported for 56 participants (75%) of 75 and were deemed treatment-related for 26 (35%). The most common unsolicited adverse events were infections, occurring in 27 participants (36%); six (8%) were deemed possibly related to study treatment. There were no laboratory abnormalities of grade 3 or higher that were related to study treatment; laboratory abnormalities were uncommon, except for 15 increases in creatine phosphokinase in 14 participants (three participants in the 0·67 mg group, three in the 2 mg group, and seven in the 6 mg group). Of these 15 increases, five (33%) were deemed possibly related to study treatment (one in the 2 mg group and four in the 6 mg group). Seroconversion measured by S1-ELISA occurred in 59 (86%) of 69 participants and 61 (94%) of 65 participants after two and three vaccinations, respectively. Neutralising antibodies were detected in 34 (50%) of 68 participants. T-cell responses were detected in 47 (71%) of 66 participants after two vaccinations and in 44 (76%) of 58 participants after three vaccinations. There were no differences in immune responses between dose groups after 6 weeks. At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">The GLS-5300 MERS coronavirus vaccine was well tolerated with no vaccine-associated serious adverse events. Immune responses were dose-independent, detected in more than 85% of participants after two vaccinations, and durable through 1 year of follow-up. The data support further development of the GLS-5300 vaccine, including additional studies to test the efficacy of GLS-5300 in a region endemic for MERS coronavirus.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">US Department of the Army and GeneOne Life Science.</AbstractText><CopyrightInformation>Copyright © 2019 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Modjarrad</LastName><ForeName>Kayvon</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Roberts</LastName><ForeName>Christine C</ForeName><Initials>CC</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea. Electronic address: croberts@geneonels-us.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mills</LastName><ForeName>Kristin T</ForeName><Initials>KT</Initials><AffiliationInfo><Affiliation>ICON Clinical Research Management, Gaithersburg, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Castellano</LastName><ForeName>Amy R</ForeName><Initials>AR</Initials><AffiliationInfo><Affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paolino</LastName><ForeName>Kristopher</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Muthumani</LastName><ForeName>Kar</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Reuschel</LastName><ForeName>Emma L</ForeName><Initials>EL</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robb</LastName><ForeName>Merlin L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Racine</LastName><ForeName>Trina</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Université Laval, Quebec City, QC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oh</LastName><ForeName>Myoung-Don</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>Seoul National University College of Medicine, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lamarre</LastName><ForeName>Claude</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Université Laval, Quebec City, QC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zaidi</LastName><ForeName>Faraz I</ForeName><Initials>FI</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boyer</LastName><ForeName>Jean</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kudchodkar</LastName><ForeName>Sagar B</ForeName><Initials>SB</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jeong</LastName><ForeName>Moonsup</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Darden</LastName><ForeName>Janice M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Park</LastName><ForeName>Young K</ForeName><Initials>YK</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scott</LastName><ForeName>Paul T</ForeName><Initials>PT</Initials><AffiliationInfo><Affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Remigio</LastName><ForeName>Celine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Parikh</LastName><ForeName>Ajay P</ForeName><Initials>AP</Initials><AffiliationInfo><Affiliation>Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wise</LastName><ForeName>Megan C</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Ami</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Duperret</LastName><ForeName>Elizabeth K</ForeName><Initials>EK</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Kevin Y</ForeName><Initials>KY</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Choi</LastName><ForeName>Hyeree</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>White</LastName><ForeName>Scott</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bagarazzi</LastName><ForeName>Mark</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>May</LastName><ForeName>Jeanine M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Emmes Corporation, Rockville, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kane</LastName><ForeName>Deborah</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Hyojin</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kobinger</LastName><ForeName>Gary</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Université Laval, Quebec City, QC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Michael</LastName><ForeName>Nelson L</ForeName><Initials>NL</Initials><AffiliationInfo><Affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weiner</LastName><ForeName>David B</ForeName><Initials>DB</Initials><AffiliationInfo><Affiliation>Wistar Institute, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Stephen J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>Walter Reed Army Institute for Research, Silver Spring, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maslow</LastName><ForeName>Joel N</ForeName><Initials>JN</Initials><AffiliationInfo><Affiliation>GeneOne Life Science, Seoul, South Korea.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT02670187</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>07</Month><Day>24</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Lancet Infect Dis</MedlineTA><NlmUniqueID>101130150</NlmUniqueID><ISSNLinking>1473-3099</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2019</Year><Month>02</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2019</Year><Month>04</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2019</Year><Month>05</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2019</Year><Month>7</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2019</Year><Month>7</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2019</Year><Month>7</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">31351922</ArticleId><ArticleId IdType="pii">S1473-3099(19)30266-X</ArticleId><ArticleId IdType="doi">10.1016/S1473-3099(19)30266-X</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li><li>Corée du Sud</li><li>États-Unis</li></country><region><li>Maryland</li><li>Pennsylvanie</li><li>Région capitale de Séoul</li></region><settlement><li>Séoul</li></settlement></list><tree><country name="États-Unis"><region name="Maryland"><name sortKey="Modjarrad, Kayvon" sort="Modjarrad, Kayvon" uniqKey="Modjarrad K" first="Kayvon" last="Modjarrad">Kayvon Modjarrad</name></region><name sortKey="Bagarazzi, Mark" sort="Bagarazzi, Mark" uniqKey="Bagarazzi M" first="Mark" last="Bagarazzi">Mark Bagarazzi</name><name sortKey="Boyer, Jean" sort="Boyer, Jean" uniqKey="Boyer J" first="Jean" last="Boyer">Jean Boyer</name><name sortKey="Castellano, Amy R" sort="Castellano, Amy R" uniqKey="Castellano A" first="Amy R" last="Castellano">Amy R. Castellano</name><name sortKey="Choi, Hyeree" sort="Choi, Hyeree" uniqKey="Choi H" first="Hyeree" last="Choi">Hyeree Choi</name><name sortKey="Darden, Janice M" sort="Darden, Janice M" uniqKey="Darden J" first="Janice M" last="Darden">Janice M. Darden</name><name sortKey="Duperret, Elizabeth K" sort="Duperret, Elizabeth K" uniqKey="Duperret E" first="Elizabeth K" last="Duperret">Elizabeth K. Duperret</name><name sortKey="Kim, Kevin Y" sort="Kim, Kevin Y" uniqKey="Kim K" first="Kevin Y" last="Kim">Kevin Y. Kim</name><name sortKey="May, Jeanine M" sort="May, Jeanine M" uniqKey="May J" first="Jeanine M" last="May">Jeanine M. May</name><name sortKey="Michael, Nelson L" sort="Michael, Nelson L" uniqKey="Michael N" first="Nelson L" last="Michael">Nelson L. Michael</name><name sortKey="Mills, Kristin T" sort="Mills, Kristin T" uniqKey="Mills K" first="Kristin T" last="Mills">Kristin T. Mills</name><name sortKey="Muthumani, Kar" sort="Muthumani, Kar" uniqKey="Muthumani K" first="Kar" last="Muthumani">Kar Muthumani</name><name sortKey="Paolino, Kristopher" sort="Paolino, Kristopher" uniqKey="Paolino K" first="Kristopher" last="Paolino">Kristopher Paolino</name><name sortKey="Parikh, Ajay P" sort="Parikh, Ajay P" uniqKey="Parikh A" first="Ajay P" last="Parikh">Ajay P. Parikh</name><name sortKey="Patel, Ami" sort="Patel, Ami" uniqKey="Patel A" first="Ami" last="Patel">Ami Patel</name><name sortKey="Reuschel, Emma L" sort="Reuschel, Emma L" uniqKey="Reuschel E" first="Emma L" last="Reuschel">Emma L. Reuschel</name><name sortKey="Robb, Merlin L" sort="Robb, Merlin L" uniqKey="Robb M" first="Merlin L" last="Robb">Merlin L. Robb</name><name sortKey="Scott, Paul T" sort="Scott, Paul T" uniqKey="Scott P" first="Paul T" last="Scott">Paul T. Scott</name><name sortKey="Thomas, Stephen J" sort="Thomas, Stephen J" uniqKey="Thomas S" first="Stephen J" last="Thomas">Stephen J. Thomas</name><name sortKey="Weiner, David B" sort="Weiner, David B" uniqKey="Weiner D" first="David B" last="Weiner">David B. Weiner</name><name sortKey="White, Scott" sort="White, Scott" uniqKey="White S" first="Scott" last="White">Scott White</name><name sortKey="Wise, Megan C" sort="Wise, Megan C" uniqKey="Wise M" first="Megan C" last="Wise">Megan C. Wise</name><name sortKey="Zaidi, Faraz I" sort="Zaidi, Faraz I" uniqKey="Zaidi F" first="Faraz I" last="Zaidi">Faraz I. Zaidi</name></country><country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Roberts, Christine C" sort="Roberts, Christine C" uniqKey="Roberts C" first="Christine C" last="Roberts">Christine C. Roberts</name></region><name sortKey="Jeong, Moonsup" sort="Jeong, Moonsup" uniqKey="Jeong M" first="Moonsup" last="Jeong">Moonsup Jeong</name><name sortKey="Kane, Deborah" sort="Kane, Deborah" uniqKey="Kane D" first="Deborah" last="Kane">Deborah Kane</name><name sortKey="Kudchodkar, Sagar B" sort="Kudchodkar, Sagar B" uniqKey="Kudchodkar S" first="Sagar B" last="Kudchodkar">Sagar B. Kudchodkar</name><name sortKey="Lee, Hyojin" sort="Lee, Hyojin" uniqKey="Lee H" first="Hyojin" last="Lee">Hyojin Lee</name><name sortKey="Maslow, Joel N" sort="Maslow, Joel N" uniqKey="Maslow J" first="Joel N" last="Maslow">Joel N. Maslow</name><name sortKey="Oh, Myoung Don" sort="Oh, Myoung Don" uniqKey="Oh M" first="Myoung-Don" last="Oh">Myoung-Don Oh</name><name sortKey="Park, Young K" sort="Park, Young K" uniqKey="Park Y" first="Young K" last="Park">Young K. Park</name><name sortKey="Remigio, Celine" sort="Remigio, Celine" uniqKey="Remigio C" first="Celine" last="Remigio">Celine Remigio</name></country><country name="Canada"><noRegion><name sortKey="Racine, Trina" sort="Racine, Trina" uniqKey="Racine T" first="Trina" last="Racine">Trina Racine</name></noRegion><name sortKey="Kobinger, Gary" sort="Kobinger, Gary" uniqKey="Kobinger G" first="Gary" last="Kobinger">Gary Kobinger</name><name sortKey="Lamarre, Claude" sort="Lamarre, Claude" uniqKey="Lamarre C" first="Claude" last="Lamarre">Claude Lamarre</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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