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

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ClinicalTrials.gov Identifier: NCT04706390
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 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 Design
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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : January 12, 2022
Estimated Study Completion Date : January 12, 2024
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. immune responses [ Time Frame: 2 months to 3 years ]
    spike antibody response to SARS-CoV-2


Secondary Outcome Measures :
  1. Duration and breadth of B- and T cell responses [ Time Frame: 2 months to 3 years ]
    compare vaccination to natural infection

  2. Immune responses in healthy people and patient groups at risk [ Time Frame: 2 months to 3 years ]
    compare between vaccination groups


Biospecimen Retention:   Samples With DNA
Blood collection including cells.

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • subjects prioritized by national vaccination program

Exclusion Criteria:

  • Children
  • unable or unwilling to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706390


Contacts
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Contact: Rebecca J Cox, PhD +4745242974 rebecca.cox@uib.no
Contact: Nina Langeland, MD +4741616450 nina.langeland@uib.no

Locations
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Norway
University of Bergen Recruiting
Bergen, Norway, 5020
Contact: Rebecca J Cox, PhD    45242974    rebecca.cox@uib.no   
Contact: Nina Langeland, MD    41616450    nina.langeland@uib.no   
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
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Principal Investigator: Rebecca J Cox, PhD University of Bergen
More Information
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Publications:

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Responsible Party: Rebecca Cox, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT04706390    
Other Study ID Numbers: COVID-19vacc-1
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be developed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Cox, University of Bergen:
Covid19
Vaccine
SARS-CoV-2 antibody
Additional relevant MeSH terms:
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Infection