Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project).
Identifieur interne : 000025 ( Main/Exploration ); précédent : 000024; suivant : 000026Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project).
Auteurs : Steven Kwasi Korang [Danemark] ; Sophie Juul [Danemark] ; Emil Eik Nielsen [Danemark] ; Joshua Feinberg [Danemark] ; Faiza Siddiqui [Danemark] ; Giok Ong [Royaume-Uni] ; Sarah Klingenberg [Danemark] ; Areti Angeliki Veroniki [Grèce, Canada] ; Fanlong Bu [République populaire de Chine] ; Lehana Thabane [Canada] ; Allan Randrup Thomsen [Danemark] ; Janus C. Jakobsen [Danemark] ; Christian Gluud [Danemark]Source :
- Systematic reviews [ 2046-4053 ] ; 2020.
Abstract
BACKGROUND
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19.
METHODS/DESIGN
We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; "active placebo;" no intervention; standard care; an "active" intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately.
DISCUSSION
COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42020196492.
DOI: 10.1186/s13643-020-01516-1
PubMed: 33218366
PubMed Central: PMC7678579
Affiliations:
- Canada, Danemark, Grèce, Royaume-Uni, République populaire de Chine
- Hovedstaden, Ontario
- Copenhague, Hamilton (Ontario), Pékin
- Université McMaster
Links toward previous steps (curation, corpus...)
Le document en format XML
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Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Veroniki, Areti Angeliki" sort="Veroniki, Areti Angeliki" uniqKey="Veroniki A" first="Areti Angeliki" last="Veroniki">Areti Angeliki Veroniki</name><affiliation wicri:level="1"><nlm:affiliation>Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece.</nlm:affiliation><country xml:lang="fr">Grèce</country><wicri:regionArea>Department of Primary Education, School of Education, University of Ioannina, Ioannina</wicri:regionArea><wicri:noRegion>Ioannina</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Bu, Fanlong" sort="Bu, Fanlong" uniqKey="Bu F" first="Fanlong" last="Bu">Fanlong Bu</name><affiliation wicri:level="3"><nlm:affiliation>Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Thabane, Lehana" sort="Thabane, Lehana" uniqKey="Thabane L" first="Lehana" last="Thabane">Lehana Thabane</name><affiliation wicri:level="4"><nlm:affiliation>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Thomsen, Allan Randrup" sort="Thomsen, Allan Randrup" uniqKey="Thomsen A" first="Allan Randrup" last="Thomsen">Allan Randrup Thomsen</name><affiliation wicri:level="3"><nlm:affiliation>Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Immunology and Microbiology, University of Copenhagen, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" 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University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen</wicri:regionArea><placeName><settlement 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Kwasi" sort="Korang, Steven Kwasi" uniqKey="Korang S" first="Steven Kwasi" last="Korang">Steven Kwasi Korang</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. steven.korang@ctu.dk.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Juul, Sophie" sort="Juul, Sophie" uniqKey="Juul S" first="Sophie" last="Juul">Sophie Juul</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Nielsen, Emil Eik" sort="Nielsen, Emil Eik" uniqKey="Nielsen E" first="Emil Eik" last="Nielsen">Emil Eik Nielsen</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Feinberg, Joshua" sort="Feinberg, Joshua" uniqKey="Feinberg J" first="Joshua" last="Feinberg">Joshua Feinberg</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Siddiqui, Faiza" sort="Siddiqui, Faiza" uniqKey="Siddiqui F" first="Faiza" last="Siddiqui">Faiza Siddiqui</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Ong, Giok" sort="Ong, Giok" uniqKey="Ong G" first="Giok" last="Ong">Giok Ong</name><affiliation wicri:level="1"><nlm:affiliation>Systematic Review Initiative, NHS Blood and Transplant, John Radcliffe Hospital, Headley Way, Oxford, OX3 9BQ, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Systematic Review Initiative, NHS Blood and Transplant, John Radcliffe Hospital, Headley Way, Oxford, OX3 9BQ</wicri:regionArea><wicri:noRegion>OX3 9BQ</wicri:noRegion></affiliation></author><author><name sortKey="Klingenberg, Sarah" sort="Klingenberg, Sarah" uniqKey="Klingenberg S" first="Sarah" last="Klingenberg">Sarah Klingenberg</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Veroniki, Areti Angeliki" sort="Veroniki, Areti Angeliki" uniqKey="Veroniki A" first="Areti Angeliki" last="Veroniki">Areti Angeliki Veroniki</name><affiliation wicri:level="1"><nlm:affiliation>Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece.</nlm:affiliation><country xml:lang="fr">Grèce</country><wicri:regionArea>Department of Primary Education, School of Education, University of Ioannina, Ioannina</wicri:regionArea><wicri:noRegion>Ioannina</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Bu, Fanlong" sort="Bu, Fanlong" uniqKey="Bu F" first="Fanlong" last="Bu">Fanlong Bu</name><affiliation wicri:level="3"><nlm:affiliation>Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Thabane, Lehana" sort="Thabane, Lehana" uniqKey="Thabane L" first="Lehana" last="Thabane">Lehana Thabane</name><affiliation wicri:level="4"><nlm:affiliation>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Thomsen, Allan Randrup" sort="Thomsen, Allan Randrup" uniqKey="Thomsen A" first="Allan Randrup" last="Thomsen">Allan Randrup Thomsen</name><affiliation wicri:level="3"><nlm:affiliation>Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Immunology and Microbiology, University of Copenhagen, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Jakobsen, Janus C" sort="Jakobsen, Janus C" uniqKey="Jakobsen J" first="Janus C" last="Jakobsen">Janus C. Jakobsen</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense</wicri:regionArea><wicri:noRegion>Odense</wicri:noRegion></affiliation></author><author><name sortKey="Gluud, Christian" sort="Gluud, Christian" uniqKey="Gluud C" first="Christian" last="Gluud">Christian Gluud</name><affiliation wicri:level="3"><nlm:affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author></analytic><series><title level="j">Systematic reviews</title><idno type="eISSN">2046-4053</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS/DESIGN</b></p><p>We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; "active placebo;" no intervention; standard care; an "active" intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION</b></p><p>COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease.</p></div><div type="abstract" xml:lang="en"><p><b>SYSTEMATIC REVIEW REGISTRATION</b></p><p>PROSPERO CRD42020196492.</p></div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">33218366</PMID><DateRevised><Year>2020</Year><Month>12</Month><Day>02</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">2046-4053</ISSN><JournalIssue CitedMedium="Internet"><Volume>9</Volume><Issue>1</Issue><PubDate><Year>2020</Year><Month>11</Month><Day>20</Day></PubDate></JournalIssue><Title>Systematic reviews</Title><ISOAbbreviation>Syst Rev</ISOAbbreviation></Journal><ArticleTitle>Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project).</ArticleTitle><Pagination><MedlinePgn>262</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13643-020-01516-1</ELocationID><Abstract><AbstractText Label="BACKGROUND">Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19.</AbstractText><AbstractText Label="METHODS/DESIGN">We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; "active placebo;" no intervention; standard care; an "active" intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately.</AbstractText><AbstractText Label="DISCUSSION">COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease.</AbstractText><AbstractText Label="SYSTEMATIC REVIEW REGISTRATION">PROSPERO CRD42020196492.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Korang</LastName><ForeName>Steven Kwasi</ForeName><Initials>SK</Initials><Identifier Source="ORCID">0000-0002-6521-0928</Identifier><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. steven.korang@ctu.dk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Juul</LastName><ForeName>Sophie</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nielsen</LastName><ForeName>Emil Eik</ForeName><Initials>EE</Initials><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Feinberg</LastName><ForeName>Joshua</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Siddiqui</LastName><ForeName>Faiza</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ong</LastName><ForeName>Giok</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Systematic Review Initiative, NHS Blood and Transplant, John Radcliffe Hospital, Headley Way, Oxford, OX3 9BQ, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Klingenberg</LastName><ForeName>Sarah</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Veroniki</LastName><ForeName>Areti Angeliki</ForeName><Initials>AA</Initials><AffiliationInfo><Affiliation>Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bu</LastName><ForeName>Fanlong</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thabane</LastName><ForeName>Lehana</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomsen</LastName><ForeName>Allan Randrup</ForeName><Initials>AR</Initials><AffiliationInfo><Affiliation>Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jakobsen</LastName><ForeName>Janus C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gluud</LastName><ForeName>Christian</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate 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sort="Feinberg, Joshua" uniqKey="Feinberg J" first="Joshua" last="Feinberg">Joshua Feinberg</name><name sortKey="Gluud, Christian" sort="Gluud, Christian" uniqKey="Gluud C" first="Christian" last="Gluud">Christian Gluud</name><name sortKey="Gluud, Christian" sort="Gluud, Christian" uniqKey="Gluud C" first="Christian" last="Gluud">Christian Gluud</name><name sortKey="Jakobsen, Janus C" sort="Jakobsen, Janus C" uniqKey="Jakobsen J" first="Janus C" last="Jakobsen">Janus C. Jakobsen</name><name sortKey="Jakobsen, Janus C" sort="Jakobsen, Janus C" uniqKey="Jakobsen J" first="Janus C" last="Jakobsen">Janus C. Jakobsen</name><name sortKey="Jakobsen, Janus C" sort="Jakobsen, Janus C" uniqKey="Jakobsen J" first="Janus C" last="Jakobsen">Janus C. Jakobsen</name><name sortKey="Juul, Sophie" sort="Juul, Sophie" uniqKey="Juul S" first="Sophie" last="Juul">Sophie Juul</name><name sortKey="Klingenberg, Sarah" sort="Klingenberg, Sarah" uniqKey="Klingenberg S" first="Sarah" last="Klingenberg">Sarah Klingenberg</name><name sortKey="Klingenberg, Sarah" sort="Klingenberg, Sarah" uniqKey="Klingenberg S" first="Sarah" last="Klingenberg">Sarah Klingenberg</name><name sortKey="Nielsen, Emil Eik" sort="Nielsen, Emil Eik" uniqKey="Nielsen E" first="Emil Eik" last="Nielsen">Emil Eik Nielsen</name><name sortKey="Siddiqui, Faiza" sort="Siddiqui, Faiza" uniqKey="Siddiqui F" first="Faiza" last="Siddiqui">Faiza Siddiqui</name><name sortKey="Thomsen, Allan Randrup" sort="Thomsen, Allan Randrup" uniqKey="Thomsen A" first="Allan Randrup" last="Thomsen">Allan Randrup Thomsen</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Ong, Giok" sort="Ong, Giok" uniqKey="Ong G" first="Giok" last="Ong">Giok Ong</name></noRegion></country><country name="Grèce"><noRegion><name sortKey="Veroniki, Areti Angeliki" sort="Veroniki, Areti Angeliki" uniqKey="Veroniki A" first="Areti Angeliki" last="Veroniki">Areti Angeliki Veroniki</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Veroniki, Areti Angeliki" sort="Veroniki, Areti Angeliki" uniqKey="Veroniki A" first="Areti Angeliki" last="Veroniki">Areti Angeliki Veroniki</name></noRegion><name sortKey="Thabane, Lehana" sort="Thabane, Lehana" uniqKey="Thabane L" first="Lehana" last="Thabane">Lehana Thabane</name></country><country name="République populaire de Chine"><noRegion><name sortKey="Bu, Fanlong" sort="Bu, Fanlong" uniqKey="Bu F" first="Fanlong" last="Bu">Fanlong Bu</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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