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

Covid19 Clinical Trial

— COVID19vac-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706390
• Other study ID #: COVID-19vacc-1
• Status: Recruiting
• Start date: January 12, 2021
• Est. completion date: December 12, 2030

Study information

• Verified date: April 2024
• Source: University of Bergen
• Contact: Rebecca J Cox, PhD
• Phone: +4745242974
• Email: rebecca.cox[@]uib.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 12, 2030
• Est. primary completion date: December 12, 2024
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• subjects prioritized by national vaccination program

Exclusion Criteria:

• Children

• unable or unwilling to provide informed consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• covid-19 vaccine
vaccination

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immune responses	spike antibody response to SARS-CoV-2	2 months to 3 years
Secondary	Duration and breadth of B- cell responses	compare serological and memory B cells after vaccination to natural infection	2 months to 3 years
Secondary	Duration and breadth of T cell responses	compare T cell responses after vaccination to natural infection	2 months to 3 years