SARS-CoV-2-specific humoral and cell-mediated immune responses after immunization with inactivated COVID-19 vaccine in kidney transplant recipients (CVIM 1 study)

  1. Jackrapong Bruminhent
  2. Chavachol Setthaudom
  3. Pongsathon Chaumdee
  4. Sarinya Boongird
  5. Sasisopin Kiertiburanakul
  6. Kumthorn Malathum
  7. Arkom Nongnuch
  8. Angsana Phuphuakrat
  9. Sopon Jirasiritham
  10. Chitimaporn Janphram
  11. Sansanee Thotsiri
  12. Supparat Upama
  13. Montira Assanatham

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Abstract

No abstract available

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  1. Version published to 10.1111/ajt.16867
  2. ScreenIT

    SciScore for 10.1101/2021.08.02.21261095: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: 2.6 Ethics approval: All patients provided written consent.
    IRB: The Institutional Review Board of the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, reviewed and approved the study protocol (approval number: MURA2021/242).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    We included KT recipients from three hospitals; Ramathibodi Hospital, Praram 9 Hospital, and Samitivej Sukhumvit Hospital, all located in Bangkok, Thailand. HMI and CMI were measured before, 4 weeks after the first dose, and 2 weeks after the second dose, using a SARS-CoV-2 immunoglobulin G (IgG) assay that tests for antibodies against the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein, SARS-CoV-2 surrogate virus neutralization test (sVNT), and an enzyme-linked immunospot (ELISpot) assay for interferon-γ (IFN-γ), respectively (Supplementary Figure 1).
    SARS-CoV-2 immunoglobulin G (IgG
    suggested: None
    2.2 SARS-CoV-2 humoral immune responses: SARS-CoV-2 anti-RBD IgG antibodies were measured using the Abbott SARS-CoV-2 IgG II Quantification assay (Abbott Diagnostics, U.S.A)
    anti-RBD IgG
    suggested: None
    The function of the anti-SARS-CoV-2 spike protein S1 RBD antibody was determined by using a SARS-CoV-2 NeutraLISA surrogate neutralization test assay (Euroimmun, Germany).
    anti-SARS-CoV-2 spike protein S1 RBD
    suggested: None
    The neutralizing antibodies in plasma were inhibit binding between RBD and angiotensin-converting enzyme 2 (ACE2) receptor.
    ACE2
    suggested: None
    Software and Algorithms
    SentencesResources
    2.2 SARS-CoV-2 humoral immune responses: SARS-CoV-2 anti-RBD IgG antibodies were measured using the Abbott SARS-CoV-2 IgG II Quantification assay (Abbott Diagnostics, U.S.A)
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Emerged spots were counted using an ImmunoSpot analyzer (Cellular Technology Limited, Shaker Heights, OH), and spot quality was checked using ImmunoSpot Software v5.0.9.15.
    ImmunoSpot
    suggested: None
    Statistical analyses were performed with Stata statistical software, version 15 (StataCorp, LLC, College Station, TX).
    Stata
    suggested: (Stata, RRID:SCR_012763)
    StataCorp
    suggested: (Stata, RRID:SCR_012763)
    In addition, the distribution of anti-RBD IgG and SARS-CoV-2-specific IFN-γ-producing SFUs/106 PBMCs were expressed as the mean with 95% CI, presented as a dot plot generated with GraphPad Prism 6.0 (GraphPad Software, Inc, San Diego, CA).
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations of this study include the small sample size. Future large-scale studies are needed to confirm our findings and further explore predictors of inadequate immune responses in these specific populations. The strength of this study is it represents one of the first studies to investigate immunogenicity and safety in SOT recipients vaccinated with an inactivated SARS-CoV-2 vaccine. Although poor anti-RBD antibody and surrogate neutralization antibody responses were observed compared with immunocompetent individuals, the assumption of inadequate humoral responses cannot yet be completely elucidated, as further studies using standardized plaque reduction neutralization tests are necessary to define a better cut-off antibody titer that correlates well with neutralization. However, we instead attempted to assess CMI, which is believed to boost a prolonged protective memory response in our susceptible patients. However, the most important thing is adherence to strict basic infection prevention measures remains crucial after immunization. So far, research focused on the effectiveness of COVID-19 vaccines in SOT recipients has not been fully explored. Our study could not report the effectiveness of this vaccine in preventing natural infection because of the short follow-up period after vaccination. Furthermore, vaccine effectiveness varies depending on the study population, the dynamics of local virus transmission, the dominance of variants of concern, and healthcare resources...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.08.02.21261095v1 on medRxiv