NCT04706390: COVID19vac-1

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

Recruiting now Last updated 19 April 2024

What this trial tests

trial testing covid-19 vaccine in Covid19 in 2,500 participants. Currently enrolling.

Timeline

12 January 2021

Primary endpoint
12 December 2024

12 December 2030

Quick facts

Lead sponsor	University of Bergen
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	2,500
Start date	12 January 2021
Primary completion	12 December 2024
Estimated completion	12 December 2030
Sites	1 location across Norway

Drugs / interventions tested

• covid-19 vaccine (COVID-19 Vaccine) — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

University of Bergen

Who can join

Adults 20 to 100, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Post COVID-19 condition after delta infection and omicron reinfection in children and adolescents.
   Ertesvåg NU, Iversen A, Blomberg B, Özgümüş T, et al · · 2023 · cited 17× · PMID 37149931 · DOI 10.1016/j.ebiom.2023.104599
2. Durable immune responses after BNT162b2 vaccination in home-dwelling old adults.
   Hansen L, Brokstad KA, Bansal A, Zhou F, et al · · 2023 · cited 15× · PMID 36643855 · DOI 10.1016/j.jvacx.2023.100262
3. A rapid antibody screening haemagglutination test for predicting immunity to SARS-CoV-2 variants of concern.
   Ertesvåg NU, Xiao J, Zhou F, Ljostveit S, et al · · 2022 · cited 8× · PMID 35603265 · DOI 10.1038/s43856-022-00091-x
4. Impact of ageing on homologous and human-coronavirus-reactive antibodies after SARS-CoV-2 vaccination or infection.
   Zhou F, Vahokoski J, Bergen COVID-19 Research Group, Langeland N, et al · · 2024 · cited 6× · PMID 38378953 · DOI 10.1038/s41541-024-00817-z
5. Vaccination prevents severe COVID-19 outcome in patients with neutralizing type 1 interferon autoantibodies.
   Wolff ASB, Hansen L, Grytaas MA, Oftedal BE, et al · · 2023 · cited 6× · PMID 37346050 · DOI 10.1016/j.isci.2023.107084
6. Three doses of Sars-CoV-2 mRNA vaccine in older adults result in similar antibody responses but reduced cellular cytokine responses relative to younger adults.
   Bredholt G, Sævik M, Søyland H, Ueland T, et al · · 2024 · cited 5× · PMID 39403561 · DOI 10.1016/j.jvacx.2024.100564
7. A Rapid Antibody Screening Haemagglutination Test for Predicting Immunity to Sars CoV-2 Variants of Concern
   Ertesvåg NU, Xiao J, Zhou F, Ljostveit S, et al · · 2021 · cited 3× · DOI 10.21203/rs.3.rs-879130/v1
8. The impact of ageing on SARS-CoV-2 and human coronavirus reactive antibodies after COVID-19 vaccination or infection
   Zhou F, Vahokoski J, Langeland N, Cox R. · · 2023 · DOI 10.21203/rs.3.rs-3355835/v1