Determine Which SARS-CoV-2 Proteins Are Frequently Recognized by T Cells in Patients With Varying HLA Types Clinical Trial
Official title:
A Blood Collection Study From Volunteers Who Have Recovered From COVID-19 Infection to Identify Immunogenic Viral Epitopes in SARS-CoV-2
| NCT number | NCT04397900 |
| Other study ID # | 1586788 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 9, 2020 |
| Est. completion date | April 12, 2021 |
| Verified date | May 2020 |
| Source | TScan Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | April 12, 2021 |
| Est. primary completion date | April 12, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlantic Health System | Morristown | New Jersey |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| TScan Therapeutics, Inc. |
United States,
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. — View Citation
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. — View Citation
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. Epub 2006 May 11. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection. | JUL2020 | ||
| Primary | Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types. | JUL2020 |