The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines.
Identifieur interne : 000241 ( Main/Exploration ); précédent : 000240; suivant : 000242The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines.
Auteurs : Richard C. Condit [États-Unis] ; Denny Kim [États-Unis] ; James S. Robertson [Royaume-Uni] ; Jean-Louis Excler [Corée du Sud] ; Marc Gurwith [États-Unis] ; Thomas P. Monath [États-Unis] ; George Pavlakis [États-Unis] ; Patricia E. Fast [États-Unis] ; Jonathan Smith [États-Unis] ; Emily R. Smith [États-Unis] ; Robert T. Chen [États-Unis] ; Sonali Kochhar [États-Unis]Source :
- Vaccine [ 1873-2518 ] ; 2020.
Descripteurs français
- KwdFr :
- MESH :
- effets indésirables : Vaccins antiviraux, Vaccins atténués.
- normes : Évaluation préclinique de médicament.
- Animaux, Appréciation des risques, Humains, Internet, Vecteurs génétiques.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Vaccines, Attenuated, Viral Vaccines.
- standards : Drug Evaluation, Preclinical.
- Animals, Genetic Vectors, Humans, Internet, Risk Assessment.
Abstract
Many of the vaccines under development for COVID-19 involve the use of viral vectors. The Brighton Collaboration Benefit-Risk Assessment of Vaccines by Technology (BRAVATO, formerly the Viral Vector Vaccine Safety Working Group, V3SWG) working group has prepared a standardized template to describe the key considerations for the benefit-risk assessment of viral vector vaccines. This will facilitate key stakeholders to anticipate potential safety issues and interpret or assess safety data. This would also help improve communication and public acceptance of licensed viral vector vaccines.
DOI: 10.1016/j.vaccine.2020.08.009
PubMed: 32907759
PubMed Central: PMC7474958
Affiliations:
- Corée du Sud, Royaume-Uni, États-Unis
- Californie, Floride, Géorgie (États-Unis), Maryland, Massachusetts, New Jersey, Région capitale de Séoul, Washington (État)
- Seattle, Séoul
- Université de Washington
Links toward previous steps (curation, corpus...)
Le document en format XML
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Smith</name><affiliation wicri:level="2"><nlm:affiliation>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA</wicri:regionArea><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Chen, Robert T" sort="Chen, Robert T" uniqKey="Chen R" first="Robert T" last="Chen">Robert T. 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Condit</name><affiliation wicri:level="2"><nlm:affiliation>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL 32610, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL 32610</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Kim, Denny" sort="Kim, Denny" uniqKey="Kim D" first="Denny" last="Kim">Denny Kim</name><affiliation wicri:level="2"><nlm:affiliation>Janssen Pharmaceuticals, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen Pharmaceuticals, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Robertson, James S" sort="Robertson, James S" uniqKey="Robertson J" first="James S" last="Robertson">James S. 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Monath</name><affiliation wicri:level="2"><nlm:affiliation>Crozet BioPharma LLC, Devens, MA 01434, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Crozet BioPharma LLC, Devens, MA 01434</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Pavlakis, George" sort="Pavlakis, George" uniqKey="Pavlakis G" first="George" last="Pavlakis">George Pavlakis</name><affiliation wicri:level="2"><nlm:affiliation>National Cancer Institute, National Institutes of Health, Frederick, MD 21702, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>National Cancer Institute, National Institutes of Health, Frederick, MD 21702</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Fast, Patricia E" sort="Fast, Patricia E" uniqKey="Fast P" first="Patricia E" last="Fast">Patricia E. Fast</name><affiliation wicri:level="2"><nlm:affiliation>International AIDS Vaccine Initiative, New York, NY 10004, USA; Stanford School of Medicine, Palo Alto, CA 94305, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>International AIDS Vaccine Initiative, New York, NY 10004, USA; Stanford School of Medicine, Palo Alto, CA 94305</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Smith, Jonathan" sort="Smith, Jonathan" uniqKey="Smith J" first="Jonathan" last="Smith">Jonathan Smith</name><affiliation wicri:level="2"><nlm:affiliation>VLP Therapeutics, Gaithersburg, MD 20878, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>VLP Therapeutics, Gaithersburg, MD 20878</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Smith, Emily R" sort="Smith, Emily R" uniqKey="Smith E" first="Emily R" last="Smith">Emily R. Smith</name><affiliation wicri:level="2"><nlm:affiliation>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA</wicri:regionArea><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Chen, Robert T" sort="Chen, Robert T" uniqKey="Chen R" first="Robert T" last="Chen">Robert T. Chen</name><affiliation wicri:level="2"><nlm:affiliation>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA</wicri:regionArea><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Kochhar, Sonali" sort="Kochhar, Sonali" uniqKey="Kochhar S" first="Sonali" last="Kochhar">Sonali Kochhar</name><affiliation wicri:level="4"><nlm:affiliation>Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA 98195, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA 98195</wicri:regionArea><placeName><region type="state">Washington (État)</region><settlement type="city">Seattle</settlement></placeName><orgName type="university">Université de Washington</orgName></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Animals (MeSH)</term><term>Drug Evaluation, Preclinical (standards)</term><term>Genetic Vectors (MeSH)</term><term>Humans (MeSH)</term><term>Internet (MeSH)</term><term>Risk Assessment (MeSH)</term><term>Vaccines, Attenuated (adverse effects)</term><term>Viral Vaccines (adverse effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Animaux (MeSH)</term><term>Appréciation des risques (MeSH)</term><term>Humains (MeSH)</term><term>Internet (MeSH)</term><term>Vaccins antiviraux (effets indésirables)</term><term>Vaccins atténués (effets indésirables)</term><term>Vecteurs génétiques (MeSH)</term><term>Évaluation préclinique de médicament (normes)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Vaccines, Attenuated</term><term>Viral Vaccines</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antiviraux</term><term>Vaccins atténués</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Évaluation préclinique de médicament</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Drug Evaluation, Preclinical</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Animals</term><term>Genetic Vectors</term><term>Humans</term><term>Internet</term><term>Risk Assessment</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Animaux</term><term>Appréciation des risques</term><term>Humains</term><term>Internet</term><term>Vecteurs génétiques</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Many of the vaccines under development for COVID-19 involve the use of viral vectors. The Brighton Collaboration Benefit-Risk Assessment of Vaccines by Technology (BRAVATO, formerly the Viral Vector Vaccine Safety Working Group, V3SWG) working group has prepared a standardized template to describe the key considerations for the benefit-risk assessment of viral vector vaccines. This will facilitate key stakeholders to anticipate potential safety issues and interpret or assess safety data. This would also help improve communication and public acceptance of licensed viral vector vaccines.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32907759</PMID><DateCompleted><Year>2020</Year><Month>12</Month><Day>10</Day></DateCompleted><DateRevised><Year>2021</Year><Month>01</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>38</Volume><Issue>49</Issue><PubDate><Year>2020</Year><Month>11</Month><Day>17</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines.</ArticleTitle><Pagination><MedlinePgn>7708-7715</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(20)31030-6</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2020.08.009</ELocationID><Abstract><AbstractText>Many of the vaccines under development for COVID-19 involve the use of viral vectors. The Brighton Collaboration Benefit-Risk Assessment of Vaccines by Technology (BRAVATO, formerly the Viral Vector Vaccine Safety Working Group, V3SWG) working group has prepared a standardized template to describe the key considerations for the benefit-risk assessment of viral vector vaccines. This will facilitate key stakeholders to anticipate potential safety issues and interpret or assess safety data. This would also help improve communication and public acceptance of licensed viral vector vaccines.</AbstractText><CopyrightInformation>Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Condit</LastName><ForeName>Richard C</ForeName><Initials>RC</Initials><AffiliationInfo><Affiliation>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL 32610, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Denny</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Janssen Pharmaceuticals, Titusville, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robertson</LastName><ForeName>James S</ForeName><Initials>JS</Initials><AffiliationInfo><Affiliation>Independent Adviser, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Excler</LastName><ForeName>Jean-Louis</ForeName><Initials>JL</Initials><AffiliationInfo><Affiliation>International Vaccine Institute, Seoul, Republic of Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gurwith</LastName><ForeName>Marc</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Monath</LastName><ForeName>Thomas P</ForeName><Initials>TP</Initials><AffiliationInfo><Affiliation>Crozet BioPharma LLC, Devens, MA 01434, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pavlakis</LastName><ForeName>George</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>National Cancer Institute, National Institutes of Health, Frederick, MD 21702, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fast</LastName><ForeName>Patricia E</ForeName><Initials>PE</Initials><AffiliationInfo><Affiliation>International AIDS Vaccine Initiative, New York, NY 10004, USA; Stanford School of Medicine, Palo Alto, CA 94305, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Jonathan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>VLP Therapeutics, Gaithersburg, MD 20878, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Emily R</ForeName><Initials>ER</Initials><AffiliationInfo><Affiliation>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Robert T</ForeName><Initials>RT</Initials><AffiliationInfo><Affiliation>Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kochhar</LastName><ForeName>Sonali</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA 98195, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>Brighton Collaboration Benefit-Risk Assessment of Vaccines by Technology (BRAVATO) Working Group. Electronic address: bc-coordinator@taskforce.org</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>06</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014613">Vaccines, Attenuated</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014765">Viral Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000818" MajorTopicYN="N">Animals</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004353" MajorTopicYN="N">Drug Evaluation, Preclinical</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005822" MajorTopicYN="N">Genetic Vectors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020407" MajorTopicYN="N">Internet</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014613" MajorTopicYN="N">Vaccines, Attenuated</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014765" MajorTopicYN="N">Viral Vaccines</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Benefit-risk</Keyword><Keyword MajorTopicYN="Y">Brighton Collaboration</Keyword><Keyword MajorTopicYN="Y">CEPI</Keyword><Keyword MajorTopicYN="Y">COVID-19</Keyword><Keyword MajorTopicYN="Y">Safety</Keyword><Keyword MajorTopicYN="Y">Template</Keyword><Keyword MajorTopicYN="Y">Vaccine</Keyword><Keyword MajorTopicYN="Y">Vector</Keyword><Keyword MajorTopicYN="Y">Viral</Keyword><Keyword MajorTopicYN="Y">Virus</Keyword></KeywordList><CoiStatement>Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>07</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>08</Month><Day>03</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>9</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>9</Month><Day>10</Day><Hour>5</Hour><Minute>28</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32907759</ArticleId><ArticleId IdType="pii">S0264-410X(20)31030-6</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2020.08.009</ArticleId><ArticleId IdType="pmc">PMC7474958</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Vaccine. 2002 Dec 13;21(3-4):298-302</Citation><ArticleIdList><ArticleId IdType="pubmed">12450705</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2015 Jan 1;33(1):62-72</Citation><ArticleIdList><ArticleId IdType="pubmed">25446819</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2015 Jan 1;33(1):73-5</Citation><ArticleIdList><ArticleId IdType="pubmed">25305565</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2016 Dec 12;34(51):6597-6609</Citation><ArticleIdList><ArticleId IdType="pubmed">27395563</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine X. 2019 Jan 29;1:100009</Citation><ArticleIdList><ArticleId IdType="pubmed">31384731</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2009 Apr 6;27(16):2282-8</Citation><ArticleIdList><ArticleId IdType="pubmed">19056451</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Corée du Sud</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Californie</li><li>Floride</li><li>Géorgie (États-Unis)</li><li>Maryland</li><li>Massachusetts</li><li>New Jersey</li><li>Région capitale de Séoul</li><li>Washington (État)</li></region><settlement><li>Seattle</li><li>Séoul</li></settlement><orgName><li>Université de Washington</li></orgName></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Condit, Richard C" sort="Condit, Richard C" uniqKey="Condit R" first="Richard C" last="Condit">Richard C. Condit</name></region><name sortKey="Chen, Robert T" sort="Chen, Robert T" uniqKey="Chen R" first="Robert T" last="Chen">Robert T. Chen</name><name sortKey="Fast, Patricia E" sort="Fast, Patricia E" uniqKey="Fast P" first="Patricia E" last="Fast">Patricia E. Fast</name><name sortKey="Gurwith, Marc" sort="Gurwith, Marc" uniqKey="Gurwith M" first="Marc" last="Gurwith">Marc Gurwith</name><name sortKey="Kim, Denny" sort="Kim, Denny" uniqKey="Kim D" first="Denny" last="Kim">Denny Kim</name><name sortKey="Kochhar, Sonali" sort="Kochhar, Sonali" uniqKey="Kochhar S" first="Sonali" last="Kochhar">Sonali Kochhar</name><name sortKey="Monath, Thomas P" sort="Monath, Thomas P" uniqKey="Monath T" first="Thomas P" last="Monath">Thomas P. Monath</name><name sortKey="Pavlakis, George" sort="Pavlakis, George" uniqKey="Pavlakis G" first="George" last="Pavlakis">George Pavlakis</name><name sortKey="Smith, Emily R" sort="Smith, Emily R" uniqKey="Smith E" first="Emily R" last="Smith">Emily R. Smith</name><name sortKey="Smith, Jonathan" sort="Smith, Jonathan" uniqKey="Smith J" first="Jonathan" last="Smith">Jonathan Smith</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Robertson, James S" sort="Robertson, James S" uniqKey="Robertson J" first="James S" last="Robertson">James S. Robertson</name></noRegion></country><country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Excler, Jean Louis" sort="Excler, Jean Louis" uniqKey="Excler J" first="Jean-Louis" last="Excler">Jean-Louis Excler</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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