About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
subjects prioritized by national vaccination program
Disqualifiers
Children
unable or unwilling to provide informed consent
Trial population
Comparator group: patients with natural SARS-CoV-2 infection Vaccine groups: Health care workers and high-risk population groups.
Trial design
Cohort
Prospective
Treatments tested in this trial
covid-19 vaccine
Biological/Vaccinevaccination
Treatment groups
Trial outcomes
Primary outcomes
immune responses
spike antibody response to SARS-CoV-2
Secondary outcomes
Duration and breadth of B- cell responses
compare serological and memory B cells after vaccination to natural infection
Duration and breadth of T cell responses
compare T cell responses after vaccination to natural infection
Sponsors and contacts
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University of Bergen
Lead sponsor
Haukeland University Hospital
Collaborator