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CompletedNCT04729452Updated May 17, 2024

Characterisation of the Immune Response to SARS-CoV-2 / COVID-19

An observational study in Covid19, sponsored by Cwm Taf University Health Board (NHS). Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by Cwm Taf University Health Board (NHS) · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study summary

Emerging clinical details of the current SARS-CoV-2 pandemic have illustrated that there are multiple clinical presentations and outcomes of this viral infection. People with an infection have been reported to have a spectrum of disease from severe acute respiratory distress requiring ventilation, to mild respiratory or gastrointestinal symptoms and asymptomatic presentations. Mechanisms explaining the heterogeneity of host response to infection are yet to be characterised.

The aim of this project is to understand the host immune response to infection with SARS-CoV-2 over time in convalescent adults, including acquired immune responses, circulating levels of immune signalling molecules, gene expression profiling in peripheral blood and to identify host genetic variants associated with disease progressions or severity. Participants will be healthcare workers who had a diagnosis of COVID-19 (confirmed by positive RT-PCR assay) more than 28 days ago and have recovered and are employed by Cwm Taf Morgannwg University health board. Samples will be processed and analysed to explore immunological, host genetic factors and virological factors that explain pathogenesis and predict outcomes of infection.

Read the detailed description

AIMS AND OBJECTIVES The objective of this project is to understand the host immune response to infection with SARS-CoV-2 over time in convalescent adults, including acquired immune responses, gene expression profiling in peripheral blood and to identify host genetic variants associated with disease progressions or severity. We would like to ascertain why different people experience different disease phenotypes with this coronavirus infection.

Our primary objective is to determine key protective cellular immune parameters (e.g. T cell responses) and confirm whether there are host genetic factors that provide protection from disease. We aim to define immunodominant SARS-CoV-2 T-cell epitopes by screening overlapping peptides from the viral proteome and mapping responses to individual COVID proteins expressed intracellularly in antigen-presenting cells (to confirm processing and presentation at the cell surface). Peptide-HLA multimers will be constructed for confirmed immunodominant responses. These reagents will allow rapid enumeration and tracking of COVID-specific T cell responses in patient samples.

Our secondary objective is to determine whether there are public (shared) T-cell receptor responses to SARS-CoV-2. We will also examine whether pre-existing T-cells responses to other viruses protect against SARS-CoV-2-induced disease (COVID-19). T-cells generated will be used to test and verify detection reagents. These reagents will be developed for various projects in Oxford University including monitoring of T-cell responses induced by COVID vaccines. We will also establish whether pre-existing cross-reactive immunity to other coronaviruses correlates with disease severity as seen with the 2009 swine flu pandemic.

02

Conditions studied

  • Covid19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 160 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Cwm Taf University Health Board (NHS) is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Health care workers who had a positive SARS-CoV-2 nasopharyngeal swab test more than 28 days before recruitment

Inclusion criteria

The study will enrol eligible participants with confirmed COVID-19 PCR-based test 28 or more days prior to recruitment and be convalescent. Participants must be 18 years old and must have the capacity to provide written consent after discussing the participant information sheet. Participants must be health care workers for Cwm Taf Morgannwg University Health board.

Exclusion criteria

Exclusion Criteria:

Participants who are acutely unwell with COVID. Participants who cannot provide informed written consent. Participants who have a clear co-infection with a relevant pathogen.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
160 participants (actual)
Patient registry
No

Interventions

  • Otherblood test

    blood test to test immune response to SARS-CoV-2

    Also known as: serial blood tests over 6 months

06

What researchers measure

Primary outcomes

  1. Determination of key protective cellular immune parameters

    Our primary objective is to determine key protective cellular immune parameters (e.g. T cell responses) and confirm whether there are host genetic factors that provide protection from disease. We aim to define immunodominant SARS-CoV-2 T-cell epitopes by screening overlapping peptides from the viral proteome and mapping responses to individual COVID proteins expressed intracellularly in antigen-presenting cells (to confirm processing and presentation at the cell surface). Peptide-HLA multimers will be constructed for confirmed immunodominant responses. These reagents will allow rapid enumeration and tracking of COVID-specific T cell responses in patient samples.

    Time frame: 2 years

Secondary outcomes

  1. Determination of public T-cell receptor response to SARS-CoV-2

    Our secondary objective is to determine whether there are public (shared) T-cell receptor responses to SARS-CoV-2. We will also examine whether pre-existing T-cells responses to other viruses protect against SARS-CoV-2-induced disease (COVID-19). T-cells generated will be used to test and verify detection reagents. These reagents will be developed for various projects in Oxford University including monitoring of T-cell responses induced by COVID vaccines. We will also establish whether pre-existing cross-reactive immunity to other coronaviruses correlates with disease severity as seen with the 2009 swine flu pandemic.

    Time frame: 3 years

07

Study locations

1 site
  • Cwm Taf Morgannwg University Health board
    Llantrisant, Rhondda Cynon Taf CF82 7XR, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04729452
Lead sponsor
Cwm Taf University Health Board (NHS)
Collaborators
Cardiff University, University of Oxford
Responsible party
Lucy Jones (Honorary Clinical Lecturer and Associate Specialist, Cwm Taf University Health Board (NHS)) — Principal investigator
First posted
Jan 28, 2021
Start date
Jun 1, 2020
Primary completion
Oct 1, 2023
Completion
Dec 1, 2023
Last update
May 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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