mRNA-1273 but not BNT162b2 induces antibodies against polyethylene glycol (PEG) contained in mRNA-based vaccine formulations

  1. Juan Manuel Carreño
  2. Gagandeep Singh
  3. Johnstone Tcheou
  4. Komal Srivastava
  5. Charles Gleason
  6. Hiromi Muramatsu
  7. Parnavi Desai
  8. Judith A. Aberg
  9. Rachel L. Miller
  10. PARIS study group
  11. Norbert Pardi
  12. Viviana Simon
  13. Florian Krammer

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Abstract

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  1. Version published to 10.1016/j.vaccine.2022.08.024
  2. ScreenIT

    SciScore for 10.1101/2022.04.15.22273914: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Study participants and human samples: Samples were collected as part of our ongoing institutional review board–approved, longitudinal observational studies (Study ID-20-00442: 64 participants; Study ID-16-01215: one participant).
    Consent: All participants signed informed consents prior to data and sample collection.
    Sex as a biological variableThe SARS-CoV-2 mRNA vaccine side effects reported from the participants selected based on their vaccine associated side effects were generally mild to moderate and self-limiting (e.g., injection site pain/swelling, fever, fatigue, etc.) with a subset of participants (N: 8, all females, three received BNT162b2 and five received mRNA-1273) reporting delayed onset, injection site rashes, redness or swelling.
    Randomizationnot detected.
    BlindingSamples were coded and analyzed in a blinded manner.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    After 2 h incubation, plates were washed three times with PBS and then incubated for 1 hour with anti-human IgG (Fab-specific) horse radish peroxidase (HRP) secondary antibody produced in goat (Sigma-Aldrich), or IgM-HRP (Southern Biotech) at a 1:3000 in 1% milk PBS.
    anti-human IgG
    suggested: None
    Specific spike/PEG-IgE antibodies were assessed by incubating with an anti-IgE HRP conjugated antibody (Invitrogen) for 1 h at a 1:2000 dilution.
    anti-IgE HRP
    suggested: None
    For the BSA control, plates were incubated with serial dilutions (2-fold) of an anti-albumin (bovine serum) rabbit IgG fraction (anti-BSA, Invitrogen) starting at a 1:1000 dilution for 1 h, followed by three washes with PBS and addition of a donkey anti-rabbit IgG HRP conjugated antibody (CiteAb) at a 1:1000 dilution.
    anti-albumin
    suggested: None
    anti-BSA
    suggested: None
    anti-rabbit IgG
    suggested: None
    Recombinant DNA
    SentencesResources
    Briefly, the spike (S) gene sequence (GenBank: MN908947) was cloned into a mammalian expression vector pCAGGs, as described (20, 21).
    pCAGGs
    suggested: RRID:Addgene_127347)
    Software and Algorithms
    SentencesResources
    Statistical analyses: Data plotting and statistical analyses were performed using GraphPad Prism 9 (GraphPad Software, San Diego, CA, USA).
    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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 10.1101/2022.04.15.22273914v1 on medRxiv