Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06435403

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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