Trials / Recruiting
RecruitingNCT04706390
Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,500 (estimated)
- Sponsor
- University of Bergen · Academic / Other
- Sex
- All
- Age
- 20 Years – 100 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | covid-19 vaccine | vaccination |
Timeline
- Start date
- 2021-01-12
- Primary completion
- 2024-12-12
- Completion
- 2030-12-12
- First posted
- 2021-01-12
- Last updated
- 2024-04-19
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT04706390. Inclusion in this directory is not an endorsement.