T Cell Response to COVID19 Vaccinated Individuals

Overview

About this study

The first aim of this study is to verify that the TCR beta sequencing and curation platforms we will be using are able to identify patients with severe COVID-19 based on the TCR repertoires. This may be accomplished by testing and analyzing results between two cohorts: patients presenting acutely to MCF with mild COVID-19 and patients presenting with severe COVID-19. This will be accomplished by utilizing the the immunoSEQ Human T-cell Receptor Beta (hsTCB) Assay (Adaptive Biothechnologies) and the publicly available ImmuneCODE Open Access Database to confirm previously published data (PMID: 34253751). Both procedures will be performed by the company that created both platforms, Adaptive Biothechnologies.

The second aim of this study is to sequence the TCR receptors of participating patients and identify TCR motifs that may indicate a predisposition to (or protection from) severe SARS-CoV-2, leading to possible risk stratification of such patients, and whether or not age, gender or ethnicity has any contribution to said risk. This may require that we examine all three cohorts listed in the Subject Information section.

The third aim is to measure SARS-CoV-2 anti-spike and anti-nucleocapsid antibodies to distinguish patients that have not been exposed to SARS-CoV-2 to those that have been exposed.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • All age groups and ethnicities will be included in this study, with a desired emphasis for older (> 55-years-old) and younger patients (< 35-years-old) and one-to-one ratio of male to female patients, including pediatric patients.
  • Patients with or without previous vaccination who are admitted to Mayo Clinic for COVID-19.
  • Vaccinated Mayo Clinic patients with asymptomatic or mild disease, which may include patients who present to the ED but then are discharged or dismissed.
  • Vaccinated Mayo Clinic patients and/or employees with no history of SARS-CoV-2 infection.

Exclusion Criteria:

  • Pregnant women.
  • Children less than 12 years of age.

Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Morice, M.D., Ph.D.

Contact us for the latest status

Contact information:

Jenna Capelle

(507) 266-5017

Capelle.Jenna@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Aziza Nassar, M.D., M.P.H.

Open for enrollment

Contact information:

Carla Palmucci CCRP

Palmucci.Carla@mayo.edu

More information

Publications

Publications are currently not available
.

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