Actively Recruiting

Age: 20Years - 100Years
All Genders
ID04706390

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

Led by University of Bergen · Updated on 2024-04-19

2500

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

U

University of Bergen

Lead Sponsor

H

Haukeland University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying and comparing the immune responses in people after natural infection with SARS-CoV-2 and after receiving COVID-19 vaccination. This observational study aims to understand differences in antibody responses, B and T cell responses, and any short- or long-term complications following infection or vaccination. It also explores if prior infection affects the immune response to vaccination and the occurrence of reinfections. The study includes groups of health care workers and patient populations prioritized for vaccination, with approximately 500-1000 health care workers and 2000 patients expected to participate. Participants will be observed based on their vaccination status or natural infection. Blood samples and clinical data will be collected repeatedly to assess immune responses over time, from 2 months up to 3 years. Participants will provide demographic and clinical information and undergo repeated blood sampling to measure immune markers and evaluate complications related to COVID-19 infection or vaccination. The primary outcome is the immune response measured over 2 months to 3 years. Secondary outcomes include the duration and breadth of B-cell and T-cell responses. The study will monitor participants' health throughout this period to gather comprehensive immune and clinical data.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects prioritized by national vaccination program
Not Eligible

You will not qualify if you...

  • Children
  • Unable or unwilling to provide informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 2 months to 3 years

Participants undergo evaluations to compare immune responses after natural COVID-19 infection and vaccination.

1 to 2 visits depending on antibody levels

Long-term Monitoring

Duration - Up to 3 years

Participants are observed over time to assess the duration and breadth of B and T cellular responses and to evaluate short and long term complications after infection or vaccination.

Periodic visits throughout the study duration

Trial Site Locations

Total: 1 location

1

University of Bergen

Bergen, Norway, 5020

Actively Recruiting

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Research Team

R

Rebecca J Cox, PhD

N

Nina Langeland, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

SARS-CoV-2-Specific Neutralizing Antibody Responses in Norwegian Health Care Workers After the First Wave of COVID-19 Pandemic: A Prospective Cohort Study.

Mai-Chi Trieu, Amit Bansal, Anders Madsen...

https://pubmed.ncbi.nlm.nih.gov/33247924

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.

Geir Bredholt, Marianne Sævik, Hanne Søyland...

https://pubmed.ncbi.nlm.nih.gov/39403561