Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination (COVID19vac-1)

University of Bergen

Status: Enrolling

Conditions: Covid19

Treatments: Biological: covid-19 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04706390

COVID-19vacc-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects prioritized by national vaccination program

Exclusion criteria

• Children
• unable or unwilling to provide informed consent

Trial design

2,500 participants in 2 patient groups

Health care workers

Description:

500-1000 health care workers prioritized for early vaccination

Treatment:

Biological: covid-19 vaccine

prioritized patient populations

Description:

2000 individuals in patient populations prioritized for vaccinations

Treatment:

Biological: covid-19 vaccine