Immunogenicity and reactogenicity after booster dose with AZD1222 via intradermal route among adult who had received CoronaVac

  1. Rapisa Nantanee
  2. Puneyavee Aikphaibul
  3. Peera Jaru-Ampornpan
  4. Pimpayao Sodsai
  5. Orawan Himananto
  6. Tuangtip Theerawit
  7. Jiratchaya Sophonphan
  8. Punyot Tovichayathamrong
  9. Kasama Manothummetha
  10. Tysdi Laohasereekul
  11. Narin Hiransuthikul
  12. Nattiya Hirankarn
  13. Thanyawee Puthanakit

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Abstract

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  1. Version published to 10.1016/j.vaccine.2022.04.067
  2. Version published to 10.1101/2021.12.12.21267695v2 on medRxiv
  3. ScreenIT

    SciScore for 10.1101/2021.12.12.21267695: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All participants gave written informed consent prior to study enrollment.
    IRB: Institutional review board of Faculty of Medicine, Chulalongkorn University approved this study (IRB no. 663/64) and parallel IM AZD1222 booster study (IRB no. 600/64).
    Sex as a biological variablenot detected.
    RandomizationImmunogenicity parameters were compared with the parallel randomized controlled trial on healthy adult with standard dose and low dose IM administration of AZD1222 booster after completing 2 doses of CoronaVac (TCTR20210722003), conducted at same settings and lab.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    2.3 Immunogenicity outcomes: All participants’ samples were tested for spike receptor binding domain (S-RBD) IgG, and functional neutralizing antibody (NAb) against SARS-CoV-2 wild type and delta variants by surrogate virus neutralization test (sVNT).
    S-RBD ) IgG
    suggested: None
    Anti- S-RBD IgG level was reported in binding-antibody units (BAU/mL) following conversion of OD450 values with the standard curve using known units of WHO international standard
    Anti-
    suggested: None
    The anti-S-RBD IgG of more than 506 BAU/ml were used in this study as a cut off for protective antibody level, which previously reported to be associated with 80% vaccine efficacy against primary symptomatic COVID-19 [20].
    anti-S-RBD IgG
    suggested: None

    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:
    However, there are some limitations, needs of skilled health providers for administration [36], and more rapid waning of neutralizing antibodies. This study was limited by cohort study design without randomized control trial but there was the parallel cohort study with similar setting that should be able to benchmark the results. There were 2 factors that differed between the 2 groups. Specifically, there was more male in the ID group and the time interval between second and third dose was 1 week longer in the ID group. However, the immune responses at baseline before the third dose were comparable. Female was reported to have higher antibody response to vaccines [37] and after severe COVID- 19 [38]. The finding of later inferior neutralizing antibodies might be attributed to this gender difference, specifically more male participants in ID cohort. This study chose to determine the levels of functional neutralizing antibodies using the surrogate virus neutralization assay, rather than standard live-virus neutralization assay. However, we used the high cut-off value at 80% of sVNT in this study. Moreover, good correlations between sVNT and live-virus neutralization have been exhibited elsewhere [18, 39–41]. The strengths of this study were reporting complete solicited reactogenicity of all 100 participants with ID booster vaccination and multiple methods were used for immunity analysis including anti-S-RBD, sVNT (wild type and delta strain) and also CMI responses. Intradermal ...

    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.

  4. Version published to 10.1101/2021.12.12.21267695v1 on medRxiv