Robust Antibody Levels in Both Diabetic and Non-Diabetic Individuals After BNT162b2 mRNA COVID-19 Vaccination

  1. Hamad Ali
  2. Abdulmohsen Alterki
  3. Sardar Sindhu
  4. Barrak Alahmad
  5. Maha Hammad
  6. Salman Al-Sabah
  7. Mohammad Alghounaim
  8. Mohammad H. Jamal
  9. Ali Aldei
  10. Mohammad J. Mairza
  11. Maitham Husain
  12. Sriraman Deverajan
  13. Rasheed Ahmad
  14. Preethi Cherian
  15. Irina Alkhairi
  16. Abdullah Alkandari
  17. Jehad Abubaker
  18. Mohamed Abu-Farha
  19. Fahd Al-Mulla

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Abstract

The emergence of effective vaccines for COVID-19 has been welcomed by the world with great optimism. Given their increased susceptibility to COVID-19, the question arises whether individuals with type-2 diabetes mellitus (T2DM) and other metabolic conditions can respond effectively to the mRNA-based vaccine. We aimed to evaluate the levels of anti-SARS-CoV-2 IgG and neutralizing antibodies in people with T2DM and/or other metabolic risk factors (hypertension and obesity) compared to those without. This study included 262 people (81 diabetic and 181 non-diabetic persons) that took two doses of BNT162b2 (Pfizer–BioNTech) mRNA vaccine. Both T2DM and non-diabetic individuals had a robust response to vaccination as demonstrated by their high antibody titers. However, both SARS-CoV-2 IgG and neutralizing antibodies titers were lower in people with T2DM. The mean ( ± 1 standard deviation) levels were 154 ± 49.1 vs. 138 ± 59.4 BAU/ml for IgG and 87.1 ± 11.6 vs. 79.7 ± 19.5% for neutralizing antibodies in individuals without diabetes compared to those with T2DM, respectively. In a multiple linear regression adjusted for individual characteristics, comorbidities, previous COVID-19 infection, and duration since second vaccine dose, diabetics had 13.86 BAU/ml (95% CI: 27.08 to 0.64 BAU/ml, p=0.041) less IgG antibodies and 4.42% (95% CI: 8.53 to 0.32%, p=0.036) fewer neutralizing antibodies than non-diabetics. Hypertension and obesity did not show significant changes in antibody titers. Taken together, both type-2 diabetic and non-diabetic individuals elicited strong immune responses to SARS-CoV-2 BNT162b2 mRNA vaccine; nonetheless, lower levels were seen in people with diabetes. Continuous monitoring of the antibody levels might be a good indicator to guide personalized needs for further booster shots to maintain adaptive immunity. Nonetheless, it is important that people get their COVID-19 vaccination especially people with diabetes.

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  1. Version published to 10.3389/fimmu.2021.752233
  2. Version published to 10.1101/2021.07.23.21261042v2 on medRxiv
  3. ScreenIT

    SciScore for 10.1101/2021.07.23.21261042: (What is this?)

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

    Table 1: Rigor

    EthicsIACUC: 2.1 Recruitment of Participants and Study Cohort: This study was reviewed and approved by the Ethical Review Committee of Dasman Diabetes Institute
    Consent: Participants were then asked to visit the Dasman Diabetes Institute where they signed up the informed consent form before participating in the study.
    Sex as a biological variablePeople with autoimmune diseases, those taking immunosuppressants or suffering from arthritis were excluded from participating in this study as well as people with Type 1 Diabetes and pregnant women.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Plasma samples were then aliquoted and stored at −80°C until the assays were performed. 2.3 Measurement of Plasma Levels of SARS-CoV-2-specific IgG: Plasma levels of SARS-CoV-2-specific IgG antibodies were detected using enzyme-linked immunosorbent assay (ELISA) kit (SERION ELISA agile SARS-CoV-2 IgG SERION Diagnostics, Würzburg, Germany), following the manufacturer’s instructions.
    SARS-CoV-2-specific IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Data for each participant were captured using a RedCap survey that included age, gender, existing diseases (e.g. diabetes and hypertension) as well as height, weight, and history of COVID-19 infection.
    RedCap
    suggested: (REDCap, RRID:SCR_003445)

    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:
    This study has a number of limitations. First, the population examined were self-selected mostly by word of mouth and recruitment advertisements. It is likely that the sample is over-representing co-morbid individuals who actively sought to know the antibody protection levels they have after vaccination. Second, the regression analyses adjusted for a number of a priori confounders, however, we cannot rule out potential residual confounding by severity of illness. For example, we could not assess whether patients with severe uncontrolled diabetes or uncontrolled hypertension show lower response to vaccine-induced humoral immunity. Third, the small sample size also limited our ability to examine the effects among different subgroups. The interaction analyses were likely underpowered to detect statistically significant differences between different strata. Fourth, the data presented represent a cross-sectional analysis of the humoral response only, therefore, further studies will be required including the longitudinal analyses of both humoral and cellular responses in the BNT162b2 vaccinees since longer-time follow-ups of both arms of the adaptive immunity can provide more precise information of the putative duration of protective immunity after vaccination. Finally, the studied population in Kuwait is likely to be homogenous and therefore the readers should be cautioned when generalizing the results to other settings and populations. We aim to further perform larger-cohort, mul...

    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

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  4. Version published to 10.1101/2021.07.23.21261042v1 on medRxiv