CovidStanfordV1, Main, Exploration, bibRecord, 000242

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.

Identifieur interne : 000242 ( Main/Exploration ); précédent : 000241; suivant : 000243

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.

Auteurs : Sonali Kochhar [États-Unis] ; Denny Kim [États-Unis] ; Jean-Louis Excler [Corée du Sud] ; Richard C. Condit [États-Unis] ; James S. Robertson [Royaume-Uni] ; Stephen Drew [États-Unis] ; Mike Whelan [Royaume-Uni] ; David Wood [Royaume-Uni] ; Patricia E. Fast [États-Unis] ; Marc Gurwith [États-Unis] ; Bettina Klug [Allemagne] ; Najwa Khuri-Bulos [Jordanie] ; Emily R. Smith [États-Unis] ; Robert T. Chen [États-Unis]

Source :

Vaccine [ 1873-2518 ] ; 2020.

RBID : pubmed:32653276

Descripteurs français

KwdFr :
- Antigènes viraux (administration et posologie), Antigènes viraux (effets indésirables), Antigènes viraux (immunologie), Appréciation des risques (MeSH), Humains (MeSH), Infections à coronavirus (immunologie), Infections à coronavirus (prévention et contrôle), Protéines virales (administration et posologie), Protéines virales (effets indésirables), Protéines virales (immunologie), Sécurité des patients (MeSH), Vaccins antiviraux (administration et posologie), Vaccins antiviraux (effets indésirables), Vaccins antiviraux (immunologie), Vaccins synthétiques (administration et posologie), Vaccins synthétiques (effets indésirables), Vaccins synthétiques (immunologie).
MESH :
- administration et posologie : Antigènes viraux, Protéines virales, Vaccins antiviraux, Vaccins synthétiques.
- effets indésirables : Antigènes viraux, Protéines virales, Vaccins antiviraux, Vaccins synthétiques.
- immunologie : Antigènes viraux, Infections à coronavirus, Protéines virales, Vaccins antiviraux, Vaccins synthétiques.
- prévention et contrôle : Infections à coronavirus.
- Appréciation des risques, Humains, Sécurité des patients.

English descriptors

KwdEn :
- Antigens, Viral (administration & dosage), Antigens, Viral (adverse effects), Antigens, Viral (immunology), COVID-19 Vaccines (MeSH), Coronavirus Infections (immunology), Coronavirus Infections (prevention & control), Humans (MeSH), Patient Safety (MeSH), Risk Assessment (MeSH), Vaccines, Synthetic (administration & dosage), Vaccines, Synthetic (adverse effects), Vaccines, Synthetic (immunology), Viral Proteins (administration & dosage), Viral Proteins (adverse effects), Viral Proteins (immunology), Viral Vaccines (administration & dosage), Viral Vaccines (adverse effects), Viral Vaccines (immunology).
MESH :
- chemical , administration & dosage : Antigens, Viral, Vaccines, Synthetic, Viral Proteins, Viral Vaccines.
- chemical , adverse effects : Antigens, Viral, Vaccines, Synthetic, Viral Proteins, Viral Vaccines.
- chemical , immunology : Antigens, Viral, Vaccines, Synthetic, Viral Proteins, Viral Vaccines.
- chemical : COVID-19 Vaccines.
- immunology : Coronavirus Infections.
- prevention & control : Coronavirus Infections.
- Humans, Patient Safety, Risk Assessment.

Abstract

Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.

DOI: 10.1016/j.vaccine.2020.06.044
PubMed: 32653276
PubMed Central: PMC7343648

Affiliations:

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 000520
to stream Main, to step Curation: 000520

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.</title>
<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, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</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="Excler, Jean Louis" sort="Excler, Jean Louis" uniqKey="Excler J" first="Jean-Louis" last="Excler">Jean-Louis Excler</name>
<affiliation wicri:level="3"><nlm:affiliation>International Vaccine Institute, Seoul, Republic of Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>International Vaccine Institute, Seoul</wicri:regionArea>
<placeName><settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Condit, Richard C" sort="Condit, Richard C" uniqKey="Condit R" first="Richard C" last="Condit">Richard C. Condit</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL</wicri:regionArea>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Robertson, James S" sort="Robertson, James S" uniqKey="Robertson J" first="James S" last="Robertson">James S. Robertson</name>
<affiliation wicri:level="1"><nlm:affiliation>Independent Adviser, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Independent Adviser</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Drew, Stephen" sort="Drew, Stephen" uniqKey="Drew S" first="Stephen" last="Drew">Stephen Drew</name>
<affiliation wicri:level="1"><nlm:affiliation>Independent Adviser, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Independent Adviser</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Whelan, Mike" sort="Whelan, Mike" uniqKey="Whelan M" first="Mike" last="Whelan">Mike Whelan</name>
<affiliation wicri:level="1"><nlm:affiliation>Project Leader, CEPI, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Project Leader, CEPI</wicri:regionArea>
<wicri:noRegion>CEPI</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wood, David" sort="Wood, David" uniqKey="Wood D" first="David" last="Wood">David Wood</name>
<affiliation wicri:level="1"><nlm:affiliation>Independent Adviser, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Independent Adviser</wicri:regionArea>
</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, USA; Stanford School of Medicine, Palo Alto, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>International AIDS Vaccine Initiative, New York, NY, USA; Stanford School of Medicine, Palo Alto, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gurwith, Marc" sort="Gurwith, Marc" uniqKey="Gurwith M" first="Marc" last="Gurwith">Marc Gurwith</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="Klug, Bettina" sort="Klug, Bettina" uniqKey="Klug B" first="Bettina" last="Klug">Bettina Klug</name>
<affiliation wicri:level="1"><nlm:affiliation>Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen</wicri:regionArea>
<wicri:noRegion>Langen</wicri:noRegion>
<wicri:noRegion>Langen</wicri:noRegion>
<wicri:noRegion>Langen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Khuri Bulos, Najwa" sort="Khuri Bulos, Najwa" uniqKey="Khuri Bulos N" first="Najwa" last="Khuri-Bulos">Najwa Khuri-Bulos</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Jordan, Amman, Jordan.</nlm:affiliation>
<country xml:lang="fr">Jordanie</country>
<wicri:regionArea>University of Jordan, Amman</wicri:regionArea>
<wicri:noRegion>Amman</wicri:noRegion>
</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. Electronic address: brightoncollaborationv3swg@gmail.com.</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>
</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2020">2020</date>
<idno type="RBID">pubmed:32653276</idno>
<idno type="pmid">32653276</idno>
<idno type="doi">10.1016/j.vaccine.2020.06.044</idno>
<idno type="pmc">PMC7343648</idno>
<idno type="wicri:Area/Main/Corpus">000520</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000520</idno>
<idno type="wicri:Area/Main/Curation">000520</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000520</idno>
<idno type="wicri:Area/Main/Exploration">000520</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en">The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.</title>
<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, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</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="Excler, Jean Louis" sort="Excler, Jean Louis" uniqKey="Excler J" first="Jean-Louis" last="Excler">Jean-Louis Excler</name>
<affiliation wicri:level="3"><nlm:affiliation>International Vaccine Institute, Seoul, Republic of Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>International Vaccine Institute, Seoul</wicri:regionArea>
<placeName><settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Condit, Richard C" sort="Condit, Richard C" uniqKey="Condit R" first="Richard C" last="Condit">Richard C. Condit</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL</wicri:regionArea>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Robertson, James S" sort="Robertson, James S" uniqKey="Robertson J" first="James S" last="Robertson">James S. Robertson</name>
<affiliation wicri:level="1"><nlm:affiliation>Independent Adviser, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Independent Adviser</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Drew, Stephen" sort="Drew, Stephen" uniqKey="Drew S" first="Stephen" last="Drew">Stephen Drew</name>
<affiliation wicri:level="1"><nlm:affiliation>Independent Adviser, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Independent Adviser</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Whelan, Mike" sort="Whelan, Mike" uniqKey="Whelan M" first="Mike" last="Whelan">Mike Whelan</name>
<affiliation wicri:level="1"><nlm:affiliation>Project Leader, CEPI, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Project Leader, CEPI</wicri:regionArea>
<wicri:noRegion>CEPI</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wood, David" sort="Wood, David" uniqKey="Wood D" first="David" last="Wood">David Wood</name>
<affiliation wicri:level="1"><nlm:affiliation>Independent Adviser, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Independent Adviser</wicri:regionArea>
</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, USA; Stanford School of Medicine, Palo Alto, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>International AIDS Vaccine Initiative, New York, NY, USA; Stanford School of Medicine, Palo Alto, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gurwith, Marc" sort="Gurwith, Marc" uniqKey="Gurwith M" first="Marc" last="Gurwith">Marc Gurwith</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="Klug, Bettina" sort="Klug, Bettina" uniqKey="Klug B" first="Bettina" last="Klug">Bettina Klug</name>
<affiliation wicri:level="1"><nlm:affiliation>Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen</wicri:regionArea>
<wicri:noRegion>Langen</wicri:noRegion>
<wicri:noRegion>Langen</wicri:noRegion>
<wicri:noRegion>Langen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Khuri Bulos, Najwa" sort="Khuri Bulos, Najwa" uniqKey="Khuri Bulos N" first="Najwa" last="Khuri-Bulos">Najwa Khuri-Bulos</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Jordan, Amman, Jordan.</nlm:affiliation>
<country xml:lang="fr">Jordanie</country>
<wicri:regionArea>University of Jordan, Amman</wicri:regionArea>
<wicri:noRegion>Amman</wicri:noRegion>
</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. Electronic address: brightoncollaborationv3swg@gmail.com.</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>
</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>Antigens, Viral (administration & dosage)</term>
<term>Antigens, Viral (adverse effects)</term>
<term>Antigens, Viral (immunology)</term>
<term>COVID-19 Vaccines (MeSH)</term>
<term>Coronavirus Infections (immunology)</term>
<term>Coronavirus Infections (prevention & control)</term>
<term>Humans (MeSH)</term>
<term>Patient Safety (MeSH)</term>
<term>Risk Assessment (MeSH)</term>
<term>Vaccines, Synthetic (administration & dosage)</term>
<term>Vaccines, Synthetic (adverse effects)</term>
<term>Vaccines, Synthetic (immunology)</term>
<term>Viral Proteins (administration & dosage)</term>
<term>Viral Proteins (adverse effects)</term>
<term>Viral Proteins (immunology)</term>
<term>Viral Vaccines (administration & dosage)</term>
<term>Viral Vaccines (adverse effects)</term>
<term>Viral Vaccines (immunology)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Antigènes viraux (administration et posologie)</term>
<term>Antigènes viraux (effets indésirables)</term>
<term>Antigènes viraux (immunologie)</term>
<term>Appréciation des risques (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Infections à coronavirus (immunologie)</term>
<term>Infections à coronavirus (prévention et contrôle)</term>
<term>Protéines virales (administration et posologie)</term>
<term>Protéines virales (effets indésirables)</term>
<term>Protéines virales (immunologie)</term>
<term>Sécurité des patients (MeSH)</term>
<term>Vaccins antiviraux (administration et posologie)</term>
<term>Vaccins antiviraux (effets indésirables)</term>
<term>Vaccins antiviraux (immunologie)</term>
<term>Vaccins synthétiques (administration et posologie)</term>
<term>Vaccins synthétiques (effets indésirables)</term>
<term>Vaccins synthétiques (immunologie)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antigens, Viral</term>
<term>Vaccines, Synthetic</term>
<term>Viral Proteins</term>
<term>Viral Vaccines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antigens, Viral</term>
<term>Vaccines, Synthetic</term>
<term>Viral Proteins</term>
<term>Viral Vaccines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Antigens, Viral</term>
<term>Vaccines, Synthetic</term>
<term>Viral Proteins</term>
<term>Viral Vaccines</term>
</keywords>
<keywords scheme="MESH" type="chemical" xml:lang="en"><term>COVID-19 Vaccines</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antigènes viraux</term>
<term>Protéines virales</term>
<term>Vaccins antiviraux</term>
<term>Vaccins synthétiques</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antigènes viraux</term>
<term>Protéines virales</term>
<term>Vaccins antiviraux</term>
<term>Vaccins synthétiques</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Antigènes viraux</term>
<term>Infections à coronavirus</term>
<term>Protéines virales</term>
<term>Vaccins antiviraux</term>
<term>Vaccins synthétiques</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Coronavirus Infections</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Coronavirus Infections</term>
</keywords>
<keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Infections à coronavirus</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Humans</term>
<term>Patient Safety</term>
<term>Risk Assessment</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Appréciation des risques</term>
<term>Humains</term>
<term>Sécurité des patients</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32653276</PMID>
<DateCompleted><Year>2020</Year>
<Month>07</Month>
<Day>27</Day>
</DateCompleted>
<DateRevised><Year>2021</Year>
<Month>01</Month>
<Day>16</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>38</Volume>
<Issue>35</Issue>
<PubDate><Year>2020</Year>
<Month>07</Month>
<Day>31</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 protein vaccines.</ArticleTitle>
<Pagination><MedlinePgn>5734-5739</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0264-410X(20)30830-6</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2020.06.044</ELocationID>
<Abstract><AbstractText>Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.</AbstractText>
<CopyrightInformation>Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><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, 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>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>Condit</LastName>
<ForeName>Richard C</ForeName>
<Initials>RC</Initials>
<AffiliationInfo><Affiliation>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Robertson</LastName>
<ForeName>James S</ForeName>
<Initials>JS</Initials>
<AffiliationInfo><Affiliation>Independent Adviser, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Drew</LastName>
<ForeName>Stephen</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Independent Adviser, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Whelan</LastName>
<ForeName>Mike</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Project Leader, CEPI, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wood</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Independent Adviser, UK.</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, USA; Stanford School of Medicine, Palo Alto, CA, USA.</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>Klug</LastName>
<ForeName>Bettina</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Khuri-Bulos</LastName>
<ForeName>Najwa</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>University of Jordan, Amman, Jordan.</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. Electronic address: brightoncollaborationv3swg@gmail.com.</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"><CollectiveName>Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)</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>07</Month>
<Day>09</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="D000956">Antigens, Viral</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000086663">COVID-19 Vaccines</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014614">Vaccines, Synthetic</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014764">Viral Proteins</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014765">Viral Vaccines</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000956" MajorTopicYN="N">Antigens, Viral</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086663" MajorTopicYN="N">COVID-19 Vaccines</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D061214" MajorTopicYN="N">Patient Safety</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014614" MajorTopicYN="N">Vaccines, Synthetic</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014764" MajorTopicYN="N">Viral Proteins</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014765" MajorTopicYN="N">Viral Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="Y">immunology</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">Peptide</Keyword>
<Keyword MajorTopicYN="Y">Protein</Keyword>
<Keyword MajorTopicYN="Y">Recombinant</Keyword>
<Keyword MajorTopicYN="Y">Safety</Keyword>
<Keyword MajorTopicYN="Y">Template</Keyword>
<Keyword MajorTopicYN="Y">Vaccine</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>06</Month>
<Day>10</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>06</Month>
<Day>15</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2020</Year>
<Month>7</Month>
<Day>13</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2020</Year>
<Month>7</Month>
<Day>28</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2020</Year>
<Month>7</Month>
<Day>13</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">32653276</ArticleId>
<ArticleId IdType="pii">S0264-410X(20)30830-6</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2020.06.044</ArticleId>
<ArticleId IdType="pmc">PMC7343648</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Allemagne</li>
<li>Corée du Sud</li>
<li>Jordanie</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Floride</li>
<li>Géorgie (États-Unis)</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="Washington (État)"><name sortKey="Kochhar, Sonali" sort="Kochhar, Sonali" uniqKey="Kochhar S" first="Sonali" last="Kochhar">Sonali Kochhar</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="Condit, Richard C" sort="Condit, Richard C" uniqKey="Condit R" first="Richard C" last="Condit">Richard C. Condit</name>
<name sortKey="Drew, Stephen" sort="Drew, Stephen" uniqKey="Drew S" first="Stephen" last="Drew">Stephen Drew</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="Smith, Emily R" sort="Smith, Emily R" uniqKey="Smith E" first="Emily R" last="Smith">Emily R. Smith</name>
</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>
<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>
<name sortKey="Whelan, Mike" sort="Whelan, Mike" uniqKey="Whelan M" first="Mike" last="Whelan">Mike Whelan</name>
<name sortKey="Wood, David" sort="Wood, David" uniqKey="Wood D" first="David" last="Wood">David Wood</name>
</country>
<country name="Allemagne"><noRegion><name sortKey="Klug, Bettina" sort="Klug, Bettina" uniqKey="Klug B" first="Bettina" last="Klug">Bettina Klug</name>
</noRegion>
</country>
<country name="Jordanie"><noRegion><name sortKey="Khuri Bulos, Najwa" sort="Khuri Bulos, Najwa" uniqKey="Khuri Bulos N" first="Najwa" last="Khuri-Bulos">Najwa Khuri-Bulos</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/CovidStanfordV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000242 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000242 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    CovidStanfordV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     pubmed:32653276
   |texte=   The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i   -Sk "pubmed:32653276" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd   \
       | NlmPubMed2Wicri -a CovidStanfordV1

This area was generated with Dilib version V0.6.38.
Data generation: Tue Feb 2 21:24:25 2021. Site generation: Tue Feb 2 21:26:08 2021

	Serveur d'exploration sur le Covid à Stanford
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur le Covid à Stanford

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki