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Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project).
Syst Rev. 2020 11 20; 9(1):262.SR

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.

Authors+Show Affiliations

Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. steven.korang@ctu.dk.Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.Systematic Review Initiative, NHS Blood and Transplant, John Radcliffe Hospital, Headley Way, Oxford, OX3 9BQ, UK.Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece. Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark.Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33218366

Citation

Korang, Steven Kwasi, et al. "Vaccines to Prevent COVID-19: a Protocol for a Living Systematic Review With Network Meta-analysis Including Individual Patient Data (The LIVING VACCINE Project)." Systematic Reviews, vol. 9, no. 1, 2020, p. 262.
Korang SK, Juul S, Nielsen EE, et al. Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project). Syst Rev. 2020;9(1):262.
Korang, S. K., Juul, S., Nielsen, E. E., Feinberg, J., Siddiqui, F., Ong, G., Klingenberg, S., Veroniki, A. A., Bu, F., Thabane, L., Thomsen, A. R., Jakobsen, J. C., & Gluud, C. (2020). Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project). Systematic Reviews, 9(1), 262. https://doi.org/10.1186/s13643-020-01516-1
Korang SK, et al. Vaccines to Prevent COVID-19: a Protocol for a Living Systematic Review With Network Meta-analysis Including Individual Patient Data (The LIVING VACCINE Project). Syst Rev. 2020 11 20;9(1):262. PubMed PMID: 33218366.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project). AU - Korang,Steven Kwasi, AU - Juul,Sophie, AU - Nielsen,Emil Eik, AU - Feinberg,Joshua, AU - Siddiqui,Faiza, AU - Ong,Giok, AU - Klingenberg,Sarah, AU - Veroniki,Areti Angeliki, AU - Bu,Fanlong, AU - Thabane,Lehana, AU - Thomsen,Allan Randrup, AU - Jakobsen,Janus C, AU - Gluud,Christian, Y1 - 2020/11/20/ PY - 2020/07/03/received PY - 2020/10/27/accepted PY - 2020/11/21/entrez PY - 2020/11/22/pubmed PY - 2020/12/15/medline SP - 262 EP - 262 JF - Systematic reviews JO - Syst Rev VL - 9 IS - 1 N2 - 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. SN - 2046-4053 UR - https://www.unboundmedicine.com/medline/citation/33218366/Vaccines_to_prevent_COVID_19:_a_protocol_for_a_living_systematic_review_with_network_meta_analysis_including_individual_patient_data__The_LIVING_VACCINE_Project__ L2 - https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-020-01516-1 DB - PRIME DP - Unbound Medicine ER -