Nucleic-acid tuberculosis vaccines: a scoping review protocol

BACKGROUNDObjectives: To comprehensively identify any vaccines against tuberculosis based on nucleic acids in development, both in preclinical and clinical studies, if any, and to provide an overview of their formulations of choice.METHODSEligibility criteria: Records will be eligible for inclusion if they report any (in vitro, in silico, or in vivo) development of a nucleic-acid-based vaccine targeted at prevention of tuberculosis. Records in languages other than English that have no associated English title and/or abstract will be excluded. Reports will be screened for eligibility against the same inclusion criterion and will be excluded if they do not provide any original primary research data, rendering filling of the data chart form impractical. Secondary/tertiary research articles (literature reviews) as well as commentaries, corrigenda, retractions, and other similar reports will also be excluded from data charting and will be treated separately.Information sources: We will search PubMed and Scopus; Embase, selected Web of Science databases, and ProQuest, if possible; Google Scholar; eLIBRARY.RU; PROSPERO, OSF Registries, and clinical trial registers (Cochrane CENTRAL and others through WHO International Clinical Trials Registry Platform Search Portal); AVMA and CABI databases; and relevant preprint servers (bioRxiv, medRxiv, and others through OSF Preprint Archive Search). We will also search references and conduct Scopus-powered forward citation search based on included reports.Risk of bias: Not applicable.Synthesis of results: No formal synthesis will be undertaken. We will descriptively summarize the content from the compiled data chart and present it in the review report in tabulated and textual formats. If the number of identified studies is considerable, we will additionally chart the bibliometric data such as publication dates. In the written text and charts, if any, we will group the synthesized data by the factors that will seem the most natural from the chart content and richness. In the Discussion, we aim to review relevant approaches to antigen discovery and features of trials (animal models) as well as to present an authors’ outlook on future perspectives in the field of vaccines against tuberculosis based on nucleic acids.OTHERFunding: This work is supported by the Ministry of Science and Higher Education of the Russian Federation (agreement No. 075-10-2021-113, unique project ID RF----193021X0001).Registration: This review has been registered in Open Science Framework Registries: https://doi.org/10.17605/OSF.IO/F7P9GKey words: tuberculosis, mRNA vaccines, DNA vaccines, scoping review.