SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Ethiopia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMichael Hoelscher

About this trial

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.

Eligibility criteria

Qualifiers

Adults, 18 years of above

Provision of oral as well as written informed consent

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).

Employed/working in hospital (medical doctors, nurses/midwives, students, auxiliary personnel such as cleaner, runner, social worker) for HCW

Disqualifiers

Prisoners

Mentally disturbed persons

Persons for whom study participation will induce an unacceptable risk or burden as judged by the investigator (e.g. seriously sick persons)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 4 trial groups

Sponsors and collaborators

Michael Hoelscher

Lead sponsor

Ludwig-Maximilians - University of Munich

Sponsor institution

St. Paul's Hospital Millennium Medical College, Ethiopia

Collaborator

Jimma University

Collaborator