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

NCT ID: NCT04706390

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-12

Study Completion Date

2030-12-12

Brief Summary

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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

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Health care workers

500-1000 health care workers prioritized for early vaccination

covid-19 vaccine

Intervention Type BIOLOGICAL

vaccination

prioritized patient populations

2000 individuals in patient populations prioritized for vaccinations

covid-19 vaccine

Intervention Type BIOLOGICAL

vaccination

Interventions

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covid-19 vaccine

vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* subjects prioritized by national vaccination program

Exclusion Criteria

* Children
* unable or unwilling to provide informed consent
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Cox

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca J Cox, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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University of Bergen

Bergen, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Rebecca J Cox, PhD

Role: CONTACT

+4745242974

Nina Langeland, MD

Role: CONTACT

+4741616450

Facility Contacts

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Rebecca J Cox, PhD

Role: primary

Nina Langeland, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32553187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33247924 (View on PubMed)

Bredholt G, Saevik M, Soyland H, Ueland T, Zhou F, Pathirana R, Madsen A, Vahokoski J, Lartey S, Halvorsen BE, Dahl TB, Trieu MC, Mohn KG, Brokstad KA, Aukrust P, Tondel C, Langeland N, Blomberg B, Cox RJ; Bergen COVID-19 Research Group. 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. Vaccine X. 2024 Sep 25;20:100564. doi: 10.1016/j.jvacx.2024.100564. eCollection 2024 Oct.

Reference Type DERIVED
PMID: 39403561 (View on PubMed)

Hansen L, Brokstad KA, Bansal A, Zhou F, Bredholt G, Onyango TB, Sandnes HH, Elyanow R, Madsen A, Trieu MC, Saevik M, Soyland H, Olofsson JS, Vahokoski J, Ertesvag NU, Fjelltveit EB, Shafiani S, Tondel C, Chapman H, Kaplan I, Mohn KGI, Langeland N, Cox RJ. Durable immune responses after BNT162b2 vaccination in home-dwelling old adults. Vaccine X. 2023 Apr;13:100262. doi: 10.1016/j.jvacx.2023.100262. Epub 2023 Jan 10.

Reference Type DERIVED
PMID: 36643855 (View on PubMed)

Other Identifiers

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COVID-19vacc-1

Identifier Type: -

Identifier Source: org_study_id

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