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

Recruiting

• Conditions: Covid19
• Interventions: Biological: covid-19 vaccine

• Registration Number: NCT04706390
• Lead Sponsor: University of Bergen

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study Start: 2021-01-12
• Study First Posted: 2021-01-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-12-12
• Study Completion: 2030-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• subjects prioritized by national vaccination program

Exclusion Criteria

• Children
• unable or unwilling to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health care workers	covid-19 vaccine	500-1000 health care workers prioritized for early vaccination
prioritized patient populations	covid-19 vaccine	2000 individuals in patient populations prioritized for vaccinations

Primary Outcome Measures

Name	Time	Method
immune responses	2 months to 3 years	spike antibody response to SARS-CoV-2

Secondary Outcome Measures

Name	Time	Method
Duration and breadth of T cell responses	2 months to 3 years	compare T cell responses after vaccination to natural infection
Duration and breadth of B- cell responses	2 months to 3 years	compare serological and memory B cells after vaccination to natural infection

Trial Locations

Locations (1)

University of Bergen; 🇳🇴 Bergen, Norway