Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 InfectionNCT04397900
Blood Collection Study From COVID-19 Convalescents Previously Hospitalized to Identify Immunogenic Viral Epitopes
An observational study of Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 Infection and Determine Which SARS-CoV-2 Proteins Are Frequently Recognized by T Cells in Patients With Varying HLA Types, run by TScan Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- 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
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2020to 12 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlantic Health System
Morristown, New Jersey, 07960
Ochsner Clinic Foundation
New Orleans, Louisiana, 70124
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection.
Measured: JUL2020
Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types.
Measured: JUL2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start9 Apr 2020
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- TScan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397900
- Sponsor's protocol ID
- 1586788
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21576510Peng 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.
PubMed 16690096Channappanavar 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.
PubMed 25056892Kula 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.
PubMed 31398327Xu 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.
PubMed 26045439
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blood Collection Study From Volunteers Who Have Recovered From COVID-19 Infection to Identify Immunogenic Viral Epitopes in SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04397900
- Acronym / sponsor ID
- 1586788
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TScan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection.
Time frame: JUL2020
Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types.
Time frame: JUL2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Background: PubMed 21576510Tang 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.
- Background: PubMed 16690096Peng 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.
- Background: PubMed 25056892Channappanavar 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.
- Background: PubMed 31398327Kula 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.
- Background: PubMed 26045439Xu 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 Infection and Determine Which SARS-CoV-2 Proteins Are Frequently Recognized by T Cells in Patients With Varying HLA Types, run by TScan Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection. (time frame: JUL2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397900, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.