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

ConditionCovid19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-100
SponsorUniversity of Bergen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • covid-19 vaccine

    Biological/Vaccine

    vaccination

Treatment groups

2,500 Participants
are divided into 2 treatment groups
Group A: Health care workers1 intervention
Group B: prioritized patient populations1 intervention

Trial outcomes

Primary outcomes

1

immune responses

spike antibody response to SARS-CoV-2

Time frame
2 months to 3 years

Secondary outcomes

1

Duration and breadth of B- cell responses

compare serological and memory B cells after vaccination to natural infection

Time frame
2 months to 3 years
2

Duration and breadth of T cell responses

compare T cell responses after vaccination to natural infection

Time frame
2 months to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bergen

Lead sponsor

Haukeland University Hospital

Collaborator