Actively Recruiting
SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Ethiopia
Led by Michael Hoelscher · Updated on 2024-07-09
1000
Participants Needed
2
Research Sites
120 weeks
Total Duration
On this page
Sponsors
M
Michael Hoelscher
Lead Sponsor
S
St. Paul's Hospital Millennium Medical College, Ethiopia
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study we aim to characterize SARS CoV-2 strain specific immune response (SARS-CoV-2 Spike IgG) in health care workers and general populations at the Jimma Medical Center and the St. Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease. Participants, stratified by SARS-CoV-2 infection and vaccination status, will be followed at 3-month intervals for a maximum of 2 years. Prevalence, incidence, and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments especially related to COVID-19 breakthrough disease in previously exposed/vaccinated participants will be performed. From a subset of selected participant blood sample, more in depth immunological analysis will be performed that include virus culture-based neutralization assays, antibody avidity assays, SARS-CoV-2 specific antibody epitope recognition using peptide arrays, and T-cell immunity assays (IGRA). We also plan to analyze and model cost-effectiveness considerations related to adapted COVID-19 vaccine strategies, specifically if SARS-CoV-2 the costs for routine sero-diagnosis in high SARS-CoV-2 prevalent population prior to vaccination will impact the decision to vaccinate (no vaccination for low-risk populations or reduced vaccine dosing) and is cost-efficient. The study is largely exploratory, providing deeper insights in SARS-CoV-2 specific immune responses and interaction with SARS-CoV-2 viral variants.
CONDITIONS
Official Title
SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Ethiopia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Provided oral and written informed consent
- Known or estimated timing of prior SARS-CoV-2 infection (confirmed or suspected COVID-19 or antibody seroconversion) for certain participant groups
- Employed or working in a hospital setting (including doctors, nurses, students, auxiliary staff) for healthcare workers
- Willing to provide blood samples for serology and immune testing
- Willing to provide health information and undergo SARS-CoV-2 testing if COVID-19 is suspected
You will not qualify if you...
- Prisoners
- Mentally disturbed individuals
- Persons for whom study participation poses an unacceptable risk or burden, such as seriously ill individuals
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Microbiology Immunology and Parasitology
Addis Ababa, Ethiopia
Actively Recruiting
2
Jimma University
Jimma, Ethiopia
Actively Recruiting
Research Team
A
Arne Kroidl, MD
CONTACT
R
Rebecca Kisch
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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