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

Completed

• Conditions: 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

• Registration Number: NCT04397900
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-09
• Status Verified: 2020-05
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-21
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types.	JUL2020
Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection.	JUL2020

Trial Locations

Locations (2)

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States