國家衛生研究院 NHRI:Item 3990099045/13933
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/13933


    Title: Safety and seroconversion of immunotherapies against sars-cov-2 infection: A systematic review and meta-analysis of clinical trials
    Authors: Ma, KSK;Lee, CC;Liu, KJ;Wei, JCC;Lee, YT;Wang, LT
    Contributors: National Institute of Cancer Research
    Abstract: Clinical trials evaluating the safety and antibody response of strategies to manipulate prophylactic and therapeutic immunity have been launched. We aim to evaluate strategies for augmentation of host immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. We searched clinical trials registered at the National Institutes of Health by 25 May 2021 and conducted analyses on inoculated populations, involved immunological processes, source of injected components, and trial phases. We then searched PubMed, Embase, Scopus, and the Cochrane Central Register of Controlled Trials for their corresponding reports published by 25 May 2021. A bivariate, random-effects meta-analysis was used to derive the pooled estimate of seroconversion and adverse events (AEs). A total of 929,359 participants were enrolled in 389 identified trials. The working mechanisms included heterologous immunity, active immunity, passive immunity, and immunotherapy, with 62.4% of the trials on vaccines. A total of 9072 healthy adults from 27 publications for 22 clinical trials on active immunity implementing vaccination were included for meta-analyses. The pooled odds ratios (ORs) of seroconversion were 13.94, 84.86, 106.03, and 451.04 (all p < 0.01) for vaccines based on protein, RNA, viral vector, and inactivated virus, compared with that of respective placebo/control treatment or pre-vaccination sera. The pooled ORs for safety, as defined by the inverse of systemic adverse events (AEs) were 0.53 (95% CI = 0.27–1.05; p = 0.07), 0.35 (95% CI = 0.16–0.75; p = 0.007), 0.32 (95% CI = 0.19–0.55; p < 0.0001), and 1.00 (95% CI = 0.73–1.36; p = 0.98) for vaccines based on protein, RNA, viral vector, and inactivated virus, compared with that of placebo/control treatment. A paradigm shift from all four immune-augmentative interventions to active immunity implementing vaccination was observed through clinical trials. The efficacy of immune responses to neutralize SARS-CoV-2 for these vaccines was promising, although systemic AEs were still evident for RNA-based and viral vector-based vaccines.
    Date: 2021-11-24
    Relation: Pathogens. 2021 Nov 24;10(12):Article number 1537.
    Link to: http://dx.doi.org/10.3390/pathogens10121537
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=2076-0817&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000736872700001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85120704007
    Appears in Collections:[Ko-Jiunn Liu] Periodical Articles

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