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Systematic Reviews
Published in: Systematic Reviews 1/2020

Open Access 01-12-2020 | COVID-19 | Protocol

Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

Authors: Steven Kwasi Korang, Sophie Juul, Emil Eik Nielsen, Joshua Feinberg, Faiza Siddiqui, Giok Ong, Sarah Klingenberg, Areti Angeliki Veroniki, Fanlong Bu, Lehana Thabane, Allan Randrup Thomsen, Janus C. Jakobsen, Christian Gluud

Published in: Systematic Reviews | Issue 1/2020

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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
Appendix
Available only for authorised users
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Metadata
Title
Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)
Authors
Steven Kwasi Korang
Sophie Juul
Emil Eik Nielsen
Joshua Feinberg
Faiza Siddiqui
Giok Ong
Sarah Klingenberg
Areti Angeliki Veroniki
Fanlong Bu
Lehana Thabane
Allan Randrup Thomsen
Janus C. Jakobsen
Christian Gluud
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
COVID-19
Published in
Systematic Reviews / Issue 1/2020
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-020-01516-1

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