Change in Symptoms and Immune Response in People with Post-Acute Sequelae of SARS-Cov-2 Infection ( PASC ) After SARS-Cov-2 Vaccination

  1. Daisy Massey
  2. Diana Berrent
  3. Athena Akrami
  4. Gina Assaf
  5. Hannah Davis
  6. Karen Harris
  7. Lisa McCorkell
  8. Aaron M Ring
  9. Wade L Schulz
  10. Hannah Wei
  11. Harlan M Krumholz
  12. Akiko Iwasaki

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Abstract

As more people are vaccinated against SARS-CoV-2, many of those already infected are still suffering from Post-Acute Sequelae (PASC). Although there is no current treatment for PASC, reports from patients that the vaccine itself improves, and in some reports, worsens, PASC symptoms may lead to a deeper understanding of the causes of PASC symptoms and viable treatments. As such, we are conducting a study that measures the changes in PASC symptoms after vaccination. We are collecting baseline self-report and biospecimens for immune assays and then are following up with participants to collect the same data at 2-weeks, 6-weeks, and 12-weeks post-vaccination (first dose). Immune assays using blood specimens will include B-cell, T-cell, and myeloid cell panels; evaluation of T-cell responsiveness to SARS-CoV-2 peptides and antigen specific response; autoantibody screening (of IgG, IgM, and IgA antibodies that attack human proteins); and TCR sequencing and antigen mapping of CD8+ T-cells. Mucosal immunity will be measured using saliva specimens. The study aims to provide answers for people with PASC, especially regarding the causes of their symptoms and how the vaccine may affect them, and clues for PASC treatment.

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  1. ScreenIT

    SciScore for 10.1101/2021.07.21.21260391: (What is this?)

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

    Table 1: Rigor

    EthicsField Sample Permit: This study will be conducted both online and in person for biospecimen collection.
    IRB: The study protocol has been reviewed and approved by the Institutional Review Board at the Yale School of Medicine. Study Population: The study inclusion and exclusion criteria are listed in Table 1.
    Consent: Minors (ages 12-17) are eligible for the study, but will require a parent or guardian to also consent to the study and be present for all study visits.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Study participants will include people aged 12 and over who either have been diagnosed with COVID-19, hospitalized due to COVID-19, or who have tested positive for SARS-CoV-2 more than 2 months prior to joining the study (PCR, antigen, or a positive T-test or antibody test at any point), and who have proof of the diagnosis, hospitalization, or positive test; who intend to receive the vaccine for SARS-CoV-2, but who have not yet received any doses of the vaccine; and who self-report that they have persistent moderate-to-severe symptoms or disability (by answering “yes” to the question: In your opinion, do you have symptoms more than 2 months after your initial COVID-19 infection (Long COVID) that interfere with your quality of life or with your ability to do your normal activities?).
    COVID-19
    suggested: None
    antigen,
    suggested: None
    Software and Algorithms
    SentencesResources
    Participant Surveys: The study will include 4 surveys to describe participants’ experience with PASC.
    PASC
    suggested: (PASC , RRID:SCR_016642)
    Data for this study will be collected, recorded, and stored using REDCap, a secure web application designed to support data capture for research studies.
    REDCap
    suggested: (REDCap, RRID:SCR_003445)
    It includes features for HIPAA compliance including real-time data entry validation (e.g. for data types and range checks), a full audit trail, user-based privileges, de-identified data export mechanism to statistical packages (SPSS, SAS, Stata and R), and integration with the institutional Active Directory.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04895189RecruitingYale COVID-19 Recovery Study

    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.

  2. Version published to 10.1101/2021.07.21.21260391v2 on medRxiv
  3. Version published to 10.1101/2021.07.21.21260391v1 on medRxiv