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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04706390
Acronym
COVID19vac-1
Enrollment
2500
Registered
2021-01-12
Start date
2021-01-12
Completion date
2030-12-12
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Covid19, Vaccine, SARS-CoV-2 antibody

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.

Interventions

BIOLOGICALcovid-19 vaccine

vaccination

Sponsors

Haukeland University Hospital
CollaboratorOTHER
University of Bergen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years

Inclusion criteria

* subjects prioritized by national vaccination program

Exclusion criteria

* Children * unable or unwilling to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
immune responses2 months to 3 yearsspike antibody response to SARS-CoV-2

Secondary

MeasureTime frameDescription
Duration and breadth of B- cell responses2 months to 3 yearscompare serological and memory B cells after vaccination to natural infection
Duration and breadth of T cell responses2 months to 3 yearscompare T cell responses after vaccination to natural infection

Countries

Norway

Contacts

Primary ContactRebecca J Cox, PhD
rebecca.cox@uib.no+4745242974
Backup ContactNina Langeland, MD
nina.langeland@uib.no+4741616450

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026