Blood Collection Study From COVID-19 Convalescents Previously Hospitalized to Identify Immunogenic Viral Epitopes
April 12, 2021 updated by: TScan Therapeutics, Inc.
A Blood Collection Study From Volunteers Who Have Recovered From COVID-19 Infection to Identify Immunogenic Viral Epitopes in SARS-CoV-2
The COVID-19 pandemic is a global emergency threatening to take millions of lives in the United States and around the world.
There is no current vaccine strategy against COVID-19 infection caused by a novel coronavirus named SARS-CoV-2.
Studies with a related coronavirus called SARS-CoV-1 that caused the SARS outbreak in 2003 indicated that memory CD8+ T cells recognizing viral epitopes persisted for more than 6 years post infection while neutralizing antibodies and memory B cells were short-lived and were undetectable after a short period of time (Tang et al., 2011; Peng et al., 2006; Channappanavar et al., 2014).
Thus, including viral epitopes that are recognized by memory CD8+ T cells is imperative for vaccines that can provide long-term immunity against SARS-CoV-2.
In this study, blood samples from COVID-19 patients who have recovered from the infection will be used to identify the viral epitopes recognized by their memory CD8+ T cells.
This will be accomplished using a genome-wide, high-throughput screening technology developed at Harvard Medical School (Kula et al., 2019) and licensed by the study sponsor, TScan Therapeutics.
A 24,000-member library that tiles across all ~100 viral isolates of SARS-CoV-2 that have been sequenced so far has already been synthesized at TScan.
Blood samples from convalescent patients are urgently needed to identify T cell receptors and immunogenic viral epitopes on SARS-CoV-2.
It is the hope that these data will inform development of a vaccine with the potential for long-lasting protection against SARS-CoV-2.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
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New Orleans, Louisiana, United States, 70124
- Ochsner Clinic Foundation
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New Jersey
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Morristown, New Jersey, United States, 07960
- Atlantic Health System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
COVID-19 convalescents previously hospitalized willing to donate blood.
Both men and women and members of all races and ethnic groups are eligible for this protocol.
It is expected that the mix of participants entering this study will reflect the demographics of the population affected by COVID-19.
Description
Inclusion Criteria:
- Laboratory-confirmed diagnosis of COVID-19 performed by The Centers for Disease Control and Prevention (CDC) at a hospital using an FDA Emergency Use Authorized molecular assay for COVID-19
- Age =>18 years at time of diagnosis of COVID-19
- Time since discontinuation of isolation of =>14 day following CDC criteria
- Ability to understand and willingness to sign an informed consent document
- No anti-pyretic use for =>17 days
- Ability to undergo blood draw for 4 tubes of blood containing approximately 7.5 mL of blood each
- Ability to travel to an assigned lab for blood draw
- Ability to waive any claim to blood samples or data obtained for this study's purpose
Exclusion Criteria:
- Any serious medical or psychiatric disorder that would interfere with the subject's safety
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Known blood disorder that would increase the risk of infection or bleeding from a simple phlebotomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection.
Time Frame: JUL2020
|
JUL2020
|
|
Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types.
Time Frame: JUL2020
|
JUL2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Channappanavar R, Fett C, Zhao J, Meyerholz DK, Perlman S. Virus-specific memory CD8 T cells provide substantial protection from lethal severe acute respiratory syndrome coronavirus infection. J Virol. 2014 Oct;88(19):11034-44. doi: 10.1128/JVI.01505-14. Epub 2014 Jul 23.
- Tang F, Quan Y, Xin ZT, Wrammert J, Ma MJ, Lv H, Wang TB, Yang H, Richardus JH, Liu W, Cao WC. Lack of peripheral memory B cell responses in recovered patients with severe acute respiratory syndrome: a six-year follow-up study. J Immunol. 2011 Jun 15;186(12):7264-8. doi: 10.4049/jimmunol.0903490. Epub 2011 May 16.
- Peng H, Yang LT, Wang LY, Li J, Huang J, Lu ZQ, Koup RA, Bailer RT, Wu CY. Long-lived memory T lymphocyte responses against SARS coronavirus nucleocapsid protein in SARS-recovered patients. Virology. 2006 Aug 1;351(2):466-75. doi: 10.1016/j.virol.2006.03.036. Epub 2006 May 11.
- Kula T, Dezfulian MH, Wang CI, Abdelfattah NS, Hartman ZC, Wucherpfennig KW, Lyerly HK, Elledge SJ. T-Scan: A Genome-wide Method for the Systematic Discovery of T Cell Epitopes. Cell. 2019 Aug 8;178(4):1016-1028.e13. doi: 10.1016/j.cell.2019.07.009.
- Xu GJ, Kula T, Xu Q, Li MZ, Vernon SD, Ndung'u T, Ruxrungtham K, Sanchez J, Brander C, Chung RT, O'Connor KC, Walker B, Larman HB, Elledge SJ. Viral immunology. Comprehensive serological profiling of human populations using a synthetic human virome. Science. 2015 Jun 5;348(6239):aaa0698. doi: 10.1126/science.aaa0698.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2020
Primary Completion (Actual)
April 12, 2021
Study Completion (Actual)
April 12, 2021
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 21, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 12, 2021
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1586788
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.