ongevity of specific and cross-reactive cellular responses to coronaviruses in comparison to serology in COVID-19 convalescent individuals

Completed

Conditions: COVID-19

Registration Number: NL-OMON25158

Lead Sponsor: Department of Viroscience, Erasmus MC; Innatoss Laboratories B.V.; TKI Life Sciences & Health, Health~Holland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

•Aged at least 18 years old
•Self-reported clinical history consistent with COVID-19
•Laboratory-confirmed history of SARS-CoV-2 infection (seroconversion)

Exclusion Criteria

There are no specific criteria for subjects to be excluded from participation in this study, as long as they adhere to the inclusion criteria mentioned above.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test the hypothesis that T-cell responses are more long-lived than antibody responses, we will compare the proportion of COVID-19 convalescent individuals with detectable T-cell and antibody responses to different SARS-CoV-2 proteins. The responses will be treated as a categorical variable (positive or negative). Cut-offs for positivity of T-cell responses to the various antigens will be established based on pre-pandemic samples in a different part of the overarching CoviCross project.<br><br>We will perform a multivariate analysis of variance (MANOVA). MANOVA compares groups on a set of dependent variables simultaneously. Rather than test group differences using several separate ANOVAs and run the risk of increased familywise error (probability of one or more Type I errors), the MANOVA approach makes a single comparison and the analysis therefore does not have to be adjusted for multiple hypothesis testing.<br>

Secondary Outcome Measures

Name	Time	Method
As secondary parameters in this study the quantity, phenotype and activation profile of T-cells specific for SARS-CoV-2 and HCoV will be studied at different times post SARS-CoV-2 infection and vaccination. These exploratory analyses will focus on parameters such as the effect of additional exposure/re-infection with SARS-CoV-2 (only expected incidentally), T-cell activation signatures and phenotypes and potentially assessed cytokine secretion profiles and will largely be described in a qualitative (not quantitative and statistical) manner.