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Blood Collection Study From COVID-19 Convalescents Previously Hospitalized to Identify Immunogenic Viral Epitopes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397900
Recruitment Status : Completed
First Posted : May 21, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
TScan Therapeutics, Inc.

Brief Summary:
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.

Condition or disease
Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 Infection Determine Which SARS-CoV-2 Proteins Are Frequently Recognized by T Cells in Patients With Varying HLA Types

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Blood Collection Study From Volunteers Who Have Recovered From COVID-19 Infection to Identify Immunogenic Viral Epitopes in SARS-CoV-2
Actual Study Start Date : April 9, 2020
Actual Primary Completion Date : April 12, 2021
Actual Study Completion Date : April 12, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection. [ Time Frame: JUL2020 ]
  2. Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types. [ Time Frame: JUL2020 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397900


Locations
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United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70124
United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
TScan Therapeutics, Inc.
Publications:
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Responsible Party: TScan Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04397900    
Other Study ID Numbers: 1586788
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases