Study on COVID-19 Immune Protection and Risk of Reinfection in Medical and Support Staff Over 48 Weeks
Led by Sun Yat-sen University · Updated on 2023-03-17
300
Participants Needed
1
Research Sites
169 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the protective effect of the immune barrier on secondary infection after COVID-19 vaccination or infection with the Omicron B A.5.2 strain. It focuses mainly on healthy participants, including medical staff, to understand how COVID-19 antibodies protect against different Omicron variants and to explore the best timing for COVID-19 vaccination after Omicron infection.
The study is a single-center, prospective, non-intervention observational study involving about 300 participants such as medical, nursing, administrative, and logistics staff who can commit to 48 weeks of follow-up. Participants are divided into two groups based on their baseline COVID-19 antibody levels positive or negative. They will undergo regular COVID-19 antibody and nucleic acid tests every 4 to 8 weeks, with about seven visits planned over 48 weeks. If a participant tests positive for COVID-19 during the study, virus strain gene sequencing will be performed, and their participation will end early.
During the study, participants will report any COVID-19 related symptoms and undergo antigen or nucleic acid testing within 48 hours if symptoms appear. The research team will monitor antibody titers, cellular immune function, and the incidence of secondary COVID-19 infections. This includes tracking changes in antibody levels and immune function over 48 weeks in both infected and uninfected individuals. The primary measure is the rate of COVID-19 reinfection between antibody positive and negative groups.
CONDITIONS
Brief Title
Evaluation of COVID-19 Immune Barrier and Reinfection Risk
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Medical, nursing, administrative, or logistics staff at the Third Affiliated Hospital of Sun Yat-Sen University or others able to cooperate with 48 weeks of follow-up
Participants must know if they have had COVID-19 and remember the time of their first infection
You will not qualify if you...
Presence of serious respiratory diseases such as asthma, bronchiectasis, chronic obstructive pulmonary disease, pulmonary interstitial disease, or tuberculosis
Having serious diseases affecting immune function, including uncontrolled or unresectable cancers, blood diseases, cachexia, active bleeding, severe malnutrition, mental illness, autoimmune diseases, or HIV
Plans for long-term assignments that prevent regular hospital follow-up
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within the first week after screening
Participants have their COVID-19 antibody titer measured to determine group assignment and baseline immune status.
1 visit (in-person)
Long-term Monitoring
Duration - 48 weeks
Participants are followed for up to 48 weeks with repeated COVID-19 antibody and nucleic acid tests every 4 to 8 weeks, depending on the epidemic situation. If symptoms occur, additional testing is required within 48 hours. Study ends early if infection is confirmed.
Approximately 7 visits spaced between 0 and 48 weeks
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
Observed protection against SARS-CoV-2 reinfection following a primary infection: A Danish cohort study among unvaccinated using two years of nationwide PCR-test data.
Daniela Michlmayr, Christian Holm Hansen, Sophie Madeleine Gubbels...
SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN).
Victoria Jane Hall, Sarah Foulkes, Andre Charlett...