Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development
Identifieur interne : 000603 ( Main/Exploration ); précédent : 000602; suivant : 000604Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development
Auteurs : Christine C. RobertsSource :
- Human Vaccines & Immunotherapeutics [ 2164-5515 ] ; 2019.
Descripteurs français
- KwdFr :
- Coronavirus du syndrome respiratoire du Moyen-Orient, Essais cliniques comme sujet, Flambées de maladies (), Humains, Infection par le virus Zika (), Infections à coronavirus (), Maladies transmissibles émergentes (), Maladies transmissibles émergentes (diagnostic), Santé publique, Techniques de laboratoire clinique (normes), Trousses de réactifs pour diagnostic (normes), Vaccins antiviraux (immunologie), Virus Zika.
- MESH :
- diagnostic : Maladies transmissibles émergentes.
- immunologie : Vaccins antiviraux.
- normes : Techniques de laboratoire clinique, Trousses de réactifs pour diagnostic.
- Coronavirus du syndrome respiratoire du Moyen-Orient, Essais cliniques comme sujet, Flambées de maladies, Humains, Infection par le virus Zika, Infections à coronavirus, Maladies transmissibles émergentes, Santé publique, Virus Zika.
English descriptors
- KwdEn :
- Clinical Laboratory Techniques (standards), Clinical Trials as Topic, Communicable Diseases, Emerging (diagnosis), Communicable Diseases, Emerging (prevention & control), Coronavirus Infections (prevention & control), Disease Outbreaks (prevention & control), Humans, Middle East Respiratory Syndrome Coronavirus, Public Health, Reagent Kits, Diagnostic (standards), Viral Vaccines (immunology), Zika Virus, Zika Virus Infection (prevention & control).
- MESH :
- chemical , immunology : Viral Vaccines.
- chemical , standards : Reagent Kits, Diagnostic.
- diagnosis : Communicable Diseases, Emerging.
- prevention & control : Communicable Diseases, Emerging, Coronavirus Infections, Disease Outbreaks, Zika Virus Infection.
- standards : Clinical Laboratory Techniques.
- Clinical Trials as Topic, Humans, Middle East Respiratory Syndrome Coronavirus, Public Health, Zika Virus.
Abstract
Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.
Url:
DOI: 10.1080/21645515.2019.1634992
PubMed: 31268394
PubMed Central: 6816404
Affiliations:
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Le document en format XML
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Roberts</name><affiliation><nlm:aff id="AFF0001"></nlm:aff></affiliation></author></analytic><series><title level="j">Human Vaccines & Immunotherapeutics</title><idno type="ISSN">2164-5515</idno><idno type="eISSN">2164-554X</idno><imprint><date when="2019">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Laboratory Techniques (standards)</term><term>Clinical Trials as Topic</term><term>Communicable Diseases, Emerging (diagnosis)</term><term>Communicable Diseases, Emerging (prevention & control)</term><term>Coronavirus Infections (prevention & control)</term><term>Disease Outbreaks (prevention & control)</term><term>Humans</term><term>Middle East Respiratory Syndrome Coronavirus</term><term>Public Health</term><term>Reagent Kits, Diagnostic (standards)</term><term>Viral Vaccines (immunology)</term><term>Zika Virus</term><term>Zika Virus Infection (prevention & control)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term><term>Essais cliniques comme sujet</term><term>Flambées de maladies ()</term><term>Humains</term><term>Infection par le virus Zika ()</term><term>Infections à coronavirus ()</term><term>Maladies transmissibles émergentes ()</term><term>Maladies transmissibles émergentes (diagnostic)</term><term>Santé publique</term><term>Techniques de laboratoire clinique (normes)</term><term>Trousses de réactifs pour diagnostic (normes)</term><term>Vaccins antiviraux (immunologie)</term><term>Virus Zika</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Viral Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="standards" xml:lang="en"><term>Reagent Kits, Diagnostic</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Communicable Diseases, Emerging</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Maladies transmissibles émergentes</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Vaccins antiviraux</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Techniques de laboratoire clinique</term><term>Trousses de réactifs pour diagnostic</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Communicable Diseases, Emerging</term><term>Coronavirus Infections</term><term>Disease Outbreaks</term><term>Zika Virus Infection</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Clinical Laboratory Techniques</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Trials as Topic</term><term>Humans</term><term>Middle East Respiratory Syndrome Coronavirus</term><term>Public Health</term><term>Zika Virus</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term><term>Essais cliniques comme sujet</term><term>Flambées de maladies</term><term>Humains</term><term>Infection par le virus Zika</term><term>Infections à coronavirus</term><term>Maladies transmissibles émergentes</term><term>Santé publique</term><term>Virus Zika</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>ABSTRACT</title><p>Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Madore, Dv" uniqKey="Madore D">DV Madore</name></author><author><name sortKey="Meade, Bd" uniqKey="Meade B">BD Meade</name></author><author><name sortKey="Rubin, F" uniqKey="Rubin F">F Rubin</name></author><author><name sortKey="Deal, C" uniqKey="Deal C">C Deal</name></author><author><name sortKey="Lynn, F" uniqKey="Lynn F">F. 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Huzly</name></author><author><name sortKey="Hanselmann, I" uniqKey="Hanselmann I">I Hanselmann</name></author><author><name sortKey="Schmidt Chanasit, J" uniqKey="Schmidt Chanasit J">J Schmidt-Chanasit</name></author><author><name sortKey="Panning, M" uniqKey="Panning M">M Panning</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="L Uillier, Ag" uniqKey="L Uillier A">AG L’Huillier</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Steinhagen, K" uniqKey="Steinhagen K">K Steinhagen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Waggoner, Jj" uniqKey="Waggoner J">JJ Waggoner</name></author><author><name sortKey="Gresh, L" uniqKey="Gresh L">L Gresh</name></author><author><name sortKey="Mohamed Hadley, A" uniqKey="Mohamed Hadley A">A Mohamed-Hadley</name></author><author><name sortKey="Ballesteros, G" uniqKey="Ballesteros G">G Ballesteros</name></author><author><name sortKey="Davila, Mj" 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sortKey="Burd, Em" uniqKey="Burd E">EM Burd</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Charrel, Rn" uniqKey="Charrel R">RN Charrel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Yamaoka, Y" uniqKey="Yamaoka Y">Y Yamaoka</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cabral Castro, Mj" uniqKey="Cabral Castro M">MJ Cabral-Castro</name></author><author><name sortKey="Cavalcanti, Mg" uniqKey="Cavalcanti M">MG Cavalcanti</name></author><author><name sortKey="Peralta, Rhs" uniqKey="Peralta R">RHS Peralta</name></author><author><name sortKey="Peralta, Jm" uniqKey="Peralta J">JM Peralta</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Barbe, B" uniqKey="Barbe B">B Barbe</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Waggoner, Jj" uniqKey="Waggoner J">JJ Waggoner</name></author><author><name sortKey="Pinsky, Ba" uniqKey="Pinsky B">BA Pinsky</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Saraswathy Subramaniam, Ts" uniqKey="Saraswathy Subramaniam T">TS Saraswathy Subramaniam</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hashemzadeh, Ms" uniqKey="Hashemzadeh M">MS Hashemzadeh</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Singh, Rk" uniqKey="Singh R">RK Singh</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Uyeki, Tm" uniqKey="Uyeki T">TM Uyeki</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Perkins, Md" uniqKey="Perkins M">MD Perkins</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list></list><tree><noCountry><name sortKey="Roberts, Christine C" sort="Roberts, Christine C" uniqKey="Roberts C" first="Christine C." last="Roberts">Christine C. 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