Investigating immune responses to SARS-CoV-2 in Ethiopia
SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Health Care Worker and Community Members From Ethiopian Related to Natural SARS CoV-2 Infection and COVID-19 Vaccination
Ludwig-Maximilians - University of Munich · NCT06435403
This study looks at how the immune system responds to COVID-19 in healthcare workers and the general public in Ethiopia to see how infection and vaccination affect protection against the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ludwig-Maximilians - University of Munich (other) |
| Locations | 2 sites (Addis Ababa and 1 other locations) |
| Trial ID | NCT06435403 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the immune response to SARS-CoV-2 among healthcare workers and the general population in Ethiopia. Participants will be stratified by their SARS-CoV-2 infection and vaccination status and followed for up to two years at three-month intervals. The study will assess the prevalence and dynamics of SARS-CoV-2 specific antibodies and their correlation with clinical immune protection against COVID-19. Additionally, in-depth immunological analyses will be conducted on a subset of participants to better understand the immune response mechanisms.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years who are healthcare workers or individuals with a confirmed or suspected history of SARS-CoV-2 infection.
Not a fit: Patients who are prisoners, mentally disturbed, or those for whom participation poses unacceptable risks will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective immune protection strategies against COVID-19, potentially guiding vaccination policies in resource-limited settings.
How similar studies have performed: Other studies have shown success in characterizing immune responses to SARS-CoV-2, but this specific approach in the Ethiopian context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Adults, 18 years of above 2. Provision of oral as well as written informed consent 3. Available estimation of the period or the time-point when SARS-CoV-2 infection occurred (e.g. confirmed or highly suspected COVID-19 disease, SARS-CoV-2 anti-nucleocapsid seroconversion) (only applicable for participants included in group 1 and 2). 4. Employed/working in hospital (medical doctors, nurses/midwives, students, auxiliary personnel such as cleaner, runner, social worker) for HCW 5. Willingness to provide blood samples by venipuncture for serology and immunological characterization 6. Willingness to provide health information, report medical events and to performed SARS-CoV-2 diagnostics (swabs for PCR) in the case of suspected COVID-19 disease Exclusion criteria: 1. Prisoners 2. Mentally disturbed persons 3. Persons for whom study participation will induce an unacceptable risk or burden as judged by the investigator (e.g. seriously sick persons)
Where this trial is running
Addis Ababa and 1 other locations
- Department of Microbiology Immunology and Parasitology — Addis Ababa, Ethiopia (RECRUITING)
- Jimma University — Jimma, Ethiopia (RECRUITING)
Study contacts
- Study coordinator: Arne Kroidl, MD
- Email: Arne.Kroidl@med.uni-muenchen.de
- Phone: +49-89-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SARS CoV 2 Infection, COVID-19 Breakthrough, COVID-19 Recurrent, COVID-19, Seroepidemiologic Studies, Longitudinal Studies, Ethiopia / epidemiology, SARS-CoV-2