Evaluation of How Long Immune Responses to SARS-CoV-2 Persist Following COVID-19 Vaccination

Conditions

COVID-19

Samer Al-Dury, J. Waldenström, Johan Ringlander, Sigrun Einarsdottir, Markus Andersson et al. (10 authors)

Infectious Diseases2023-07-038 citations

10.1080/23744235.2023.2230289

Induction and subsequent decline of S1-specific T cell reactivity after COVID-19 vaccination

Andreas Törnell, Hanna Grauers Wiktorin, Johan Ringlander, Mohammad Arabpour, Staffan Nilsson et al. (9 authors)

Clinical Immunology2023-01-282 citations

10.1016/j.clim.2023.109248

Impaired SARS-CoV-2-specific T-cell reactivity in patients with cirrhosis following mRNA COVID-19 vaccination.

Al-Dury S, Waern J, Waldenström J, Alavanja M, Saed HH, Törnell A, Arabpour M, Wiktorin HG, Einarsdottir S, Ringlander J, Ringström G, Hellstrand K, Martner A, Lagging M.

2022-04-2723 citations

10.1016/j.jhepr.2022.100496

Rapid Cytokine Release Assays for Analysis of Severe Acute Respiratory Syndrome Coronavirus 2–Specific T Cells in Whole Blood

Andreas Törnell, Hanna Grauers Wiktorin, Johan Ringlander, Mohammad Arabpour, Malin Nilsson et al. (11 authors)

The Journal of Infectious Diseases2022-01-0711 citations

10.1093/infdis/jiac005

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Trade Name: COVID-19 Vaccine Moderna Pharmaceutical Form: Trade Name: COVID-19 Vaccine AstraZeneca Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All participants must give written informed consent 2. Woman or man aged 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1. Inability to give written informed consent 2. Inability to undergo blood sampling, e.g. due to lack of suitable blood vessels for sampling

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of the study is to evaluate the durability of immune responses following vaccination for COVID-19 aiming at identifying correlates of vaccine-induced protection among patients with liver cirrhosis, advanced chronic kidney disease (CDK), and immunosuppression as well as healthy participants using: 1.a novel rapid spike interferon-gamma release assay 2.a novel rapid spike activation-induced marker assay 3.anti-spike IgG serology ;Secondary Objective: Secondary aims include: 1.further evaluating immunologic T cell memory after vaccination by analyzing spike-specific T-helper follicular cells by adding PD1, CXCR5, CCR6 and CXCR3 2.evaluating the association between anti-spike IgG signal-to-cutoff ratio and neutralizing antibody titration 3.evaluating the impact of human genetic variants on these vaccine-induced immune responses and possible short- and long-term adverse reactions. 4.evaluating the impact of prior natural exposure to SARS-CoV-2 on these vaccine-induced immune responses and possible short- and long-term adverse reactions. 5.evaluating possible differences between the various vaccines that will be used for immunization in Gothenburg on efficacy, immune responses and possible adverse reactions. 6.evaluating mucosal antibody responses by analysis of immune responses in saliva. ;Primary end point(s): Immune responses following vaccination for COVID-19 as measured by: 1.a novel rapid spike interferon-gamma release assay 2.a novel rapid spike activation-induced marker assay 3.anti-spike IgG serology ;Timepoint(s) of evaluation of this end point: Immediately before the 1st and 2nd vaccine doses, 4 weeks post-2nd dose, and then every 3 months for at least 2 years.	—

Measure

Time frame

Main Objective: The primary aim of the study is to evaluate the durability of immune responses following vaccination for COVID-19 aiming at identifying correlates of vaccine-induced protection among patients with liver cirrhosis, advanced chronic kidney disease (CDK), and immunosuppression as well as healthy participants using: 1.a novel rapid spike interferon-gamma release assay 2.a novel rapid spike activation-induced marker assay 3.anti-spike IgG serology ;Secondary Objective: Secondary aims include: 1.further evaluating immunologic T cell memory after vaccination by analyzing spike-specific T-helper follicular cells by adding PD1, CXCR5, CCR6 and CXCR3 2.evaluating the association between anti-spike IgG signal-to-cutoff ratio and neutralizing antibody titration 3.evaluating the impact of human genetic variants on these vaccine-induced immune responses and possible short- and long-term adverse reactions. 4.evaluating the impact of prior natural exposure to SARS-CoV-2 on these vaccine-induced immune responses and possible short- and long-term adverse reactions. 5.evaluating possible differences between the various vaccines that will be used for immunization in Gothenburg on efficacy, immune responses and possible adverse reactions. 6.evaluating mucosal antibody responses by analysis of immune responses in saliva. ;Primary end point(s): Immune responses following vaccination for COVID-19 as measured by: 1.a novel rapid spike interferon-gamma release assay 2.a novel rapid spike activation-induced marker assay 3.anti-spike IgG serology ;Timepoint(s) of evaluation of this end point: Immediately before the 1st and 2nd vaccine doses, 4 weeks post-2nd dose, and then every 3 months for at least 2 years.

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Secondary

Measure	Time frame
Secondary end point(s): Immediately before the 1st and 2nd vaccine doses, 4 weeks post-2nd dose, and then every 3 months for at least 2 years.;Timepoint(s) of evaluation of this end point: Immediately before the 1st and 2nd vaccine doses, 4 weeks post-2nd dose, and then every 3 months for at least 2 years.	—

Countries

Sweden

Outcome results

None listed