Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination

Study Overview
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Brief Summary
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The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.

Detailed Description
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The primary aim of this study is To compare immune responses after natural SARS-CoV-2 infection and COVID-19 vaccination The secondary aims are To compare the duration and breadth of antibody responses between natural infection and vaccination. To investigate the duration and breadth of B and T cellular responses between natural infection and vaccination. To evaluate the short and long term complications after natural infection and vaccination. To find out if previous infection skews the immune response after vaccination. To study reinfection after natural infection and vaccination.

Official Title
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Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination

Conditions
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Covid19

Intervention / Treatment
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* Biological: covid-19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects prioritized by national vaccination program Exclusion Criteria: Children unable or unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health care workers<br>500-1000 health care workers prioritized for early vaccination | Biological: covid-19 vaccine<br>* vaccination<br>|
| prioritized patient populations<br>2000 individuals in patient populations prioritized for vaccinations | Biological: covid-19 vaccine<br>* vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune responses | spike antibody response to SARS-CoV-2 | 2 months to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration and breadth of B- cell responses | compare serological and memory B cells after vaccination to natural infection | 2 months to 3 years | 
| Duration and breadth of T cell responses | compare T cell responses after vaccination to natural infection | 2 months to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Vaccine, SARS-CoV-2 antibody