Actively Recruiting
SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Health Care Worker and Community Members From Ethiopia Related to Natural Infection and Vaccination
Led by Michael Hoelscher · Updated on 2024-07-09
1000
Participants Needed
2
Research Sites
N/A
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
This research aims to investigate the immune response specific to different strains of SARS-CoV-2, focusing on the spike protein antibody (SARS-CoV-2 Spike IgG) among health care workers and the general population in Ethiopia. The study seeks to understand how natural infection and vaccination influence immune protection and COVID-19 disease progression, especially in a setting with high prior infection rates but low vaccination coverage. The investigation will also explore cost-effectiveness of vaccination strategies considering natural immunity and routine sero-diagnosis in a largely exploratory, longitudinal design. Participants are divided into groups based on prior SARS-CoV-2 infection and vaccination status, including those with and without anti-nucleocapsid antibodies and vaccinated or unvaccinated individuals. They will be followed at three-month intervals for up to two years, with immune responses measured regularly. Blood samples will be collected for serology and detailed immunological analyses such as neutralization assays, antibody affinity studies, epitope mapping, and T-cell response tests. The study also includes monitoring circulating viral variants and modeling vaccination strategies adapted to African contexts. During the study, participants will undergo clinical assessments, SARS-CoV-2 PCR testing, and serological evaluations every three months to monitor antibody prevalence, incidence, and dynamics. A subset of samples will be further analyzed in specialized labs abroad. Researchers will assess clinical outcomes such as COVID-19 breakthrough infections and severe disease occurrence. The study integrates computational modeling to better understand immune protection and examines the economic implications of vaccination approaches. Participation may last up to 24 months with periodic visits and health information collection.
CONDITIONS
Brief 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
- Provide oral and written informed consent
- Have an estimated time or period of SARS-CoV-2 infection (for certain groups)
- Employed or working in a hospital (including doctors, nurses, students, auxiliary staff)
- Willing to provide blood samples for serology and immune tests
- Willing to provide health information and undergo COVID-19 testing if symptoms arise
You will not qualify if you...
- Prisoners
- Mentally disturbed individuals
- Persons for whom participation poses unacceptable risk or burden as judged by the investigator (e.g., seriously ill)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants are followed up every 3 months to measure SARS-CoV-2 specific immune responses and assess COVID-19 exposure and disease.
Quarterly visits every 3 months for up to 24 months
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
R
Rebecca Kisch
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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