Effectiveness, Safety, and Immunogenicity of a Second COVID-19 Vaccine Booster in the Elderly: A Systematic Review and Meta-Analysis Protocol
Abstract
Background/aims: Older adults remain highly vulnerable to severe COVID-19 outcomes due to immunosenescence and comorbidities. Although booster vaccination strategies have reduced hospitalizations and mortality, evidence regarding the effectiveness, safety, and immunogenicity of a second COVID-19 vaccine booster dose in older adults remains fragmented. This systematic review and meta-analysis protocol aims to critically evaluate the available evidence from randomized and nonrandomized clinical trials (NRCTs) regarding the effectiveness, safety, and immunogenicity of the second COVID-19 vaccine booster in older adults worldwide.
Methods: A systematic review of clinical trials will be conducted using PubMed/MEDLINE, EMBASE, Cochrane Library, Web of Science, Scopus, and LILACS, without restrictions on publication date or language. Eligible studies will include randomized controlled trials and NRCTs involving older adults aged ≥ 60 years who received a second COVID-19 vaccine booster dose. Primary outcomes will include measures related to effectiveness, safety, and/or immunogenicity. Study selection will follow PRISMA-2020 guidelines. Risk of bias will be assessed using RoB 2 and ROBINS-I tools, while certainty of evidence will be evaluated using the GRADE approach.
Results: A narrative synthesis will be performed, and meta-analysis will be conducted whenever methodologically appropriate.
Conclusion: This review will provide comprehensive evidence regarding second COVID-19…
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Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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