Clinical trial NCT04706390: Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination
Official title: Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Keywords: Covid19
Vaccine
SARS-CoV-2 antibody
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2021-01-12
Enrollment: 2500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Comparator group: patients with natural SARS-CoV-2 infection Vaccine groups: Health care workers and high-risk population groups.

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.

Eligibility criteria: Inclusion Criteria:

* subjects prioritized by national vaccination program

Exclusion Criteria:

* Children
* unable or unwilling to provide informed consent

Primary outcomes:
measure: immune responses
timeFrame: 2 months to 3 years
Secondary outcomes:
measure: Duration and breadth of B- cell responses
timeFrame: 2 months to 3 years
measure: Duration and breadth of T cell responses
timeFrame: 2 months to 3 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
affiliation: University of Bergen
name: Rebecca J Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox RJ, Brokstad KA, Krammer F, Langeland N; Bergen COVID-19 Research Group. Seroconversion in household members of COVID-19 outpatients. Lancet Infect Dis. 2021 Feb;21(2):168. doi: 10.1016/S1473-3099(20)30466-7. Epub 2020 Jun 15. No abstract available.
citation: Trieu MC, Bansal A, Madsen A, Zhou F, Saevik M, Vahokoski J, Brokstad KA, Krammer F, Tondel C, Mohn KGI, Blomberg B, Langeland N, Cox RJ; Bergen COVID-19 Research Group. SARS-CoV-2-Specific Neutralizing Antibody Responses in Norwegian Health Care Workers After the First Wave of COVID-19 Pandemic: A Prospective Cohort Study. J Infect Dis. 2021 Feb 24;223(4):589-599. doi: 10.1093/infdis/jiaa737.