Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination (COVID19vac-1)

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: covid-19 vaccine

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.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Rebecca J Cox, PhD; Phone Number: +4745242974; Email: rebecca.cox@uib.no
• Study Contact Backup: Name: Nina Langeland, MD; Phone Number: +4741616450; Email: nina.langeland@uib.no

Study Locations

• Norway
  • Bergen, Norway, 5020
    • Recruiting
    • University of Bergen
    • Contact: Rebecca J Cox, PhD; Phone Number: 45242974; Email: rebecca.cox@uib.no
    • Contact: Nina Langeland, MD; Phone Number: 41616450; Email: nina.langeland@uib.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• subjects prioritized by national vaccination program

Exclusion Criteria:

• Children
• unable or unwilling to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health care workers; 500-1000 health care workers prioritized for early vaccination	Biological: covid-19 vaccine; vaccination
prioritized patient populations; 2000 individuals in patient populations prioritized for vaccinations	Biological: covid-19 vaccine; vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune responses	spike antibody response to SARS-CoV-2	2 months to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration and breadth of B- cell responses	compare serological and memory B cells after vaccination to natural infection	2 months to 3 years
Duration and breadth of T cell responses	compare T cell responses after vaccination to natural infection	2 months to 3 years

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Haukeland University Hospital
• Investigators: Principal Investigator: Rebecca J Cox, PhD, University of Bergen

Publications and helpful links

General Publications

• 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. Erratum In: Lancet Infect Dis. 2020 Sep;20(9):e215.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Estimated): December 12, 2024
• Study Completion (Estimated): December 12, 2030

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Covid19; Vaccine; SARS-CoV-2 antibody
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID-19vacc-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be developed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No