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

NCT06435403 | Recruiting

• 1 other identifier: ETH-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

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

SARS CoV 2 Infection; COVID-19 Breakthrough; COVID-19 Recurrent

Keywords

COVID-19; Seroepidemiologic Studies; Longitudinal Studies; Ethiopia / epidemiology; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Difference of antibody levels between study groups by month 12

  Antibody levels will be compared between study groups by month 12

  12 months

• Proportion of participants with suspected clinically reported severe COVID-19 disease or evidence of SARS-CoV-2 exposure between study groups by month 12

  The proportion of participants with suspected clinically reported severe COVID-19 disease or evidence of SARS-CoV-2 exposure between study groups by month 12 will be compared

  12 months

• Proportion of SARS-CoV-2 breakthrough infections in previously exposed/vaccinated participants

  The proportion of SARS-CoV-2 breakthrough infections in previously exposed/vaccinated will be compared

  24 months

Secondary Outcomes (5)

• Difference of antibody levels between groups by month 6, 18 and 24

  24 months

• Antibody levels after single 1st vaccination in previously infected persons

  24 months

• Proportion of participants with suspected clinically reported severe COVID-19 disease or evidence of SARS-CoV-2 exposure between study groups by month 6, 18 and 24

  24 months

• Prevalence and distribution of circulating SARS-CoV-2 variants around baseline and during the study period

  24 months

• Comparing costs related to SARS-CoV-2 anti-nucleocapsid diagnostics in relation to spared costs by abbreviated/not performed COVID-19 vaccine regimen

  24 months

Other Outcomes (3)

• Difference of neutralizing antibodies in a subset of participants by study groups at baseline and subsequent time points

  24 months

• Recognition of SARS-CoV-2 specific peptide in a subset of participants by study groups at baseline and subsequent time points

  24 months

• Determination of upper respiratory viral load in subjects with (re)infection

  24 months

Study Arms (4)

Group 1 (N=300)

SARS-CoV-2 anti-nucleocapsid positive, vaccinated

Group 2 (N=300)

SARS-CoV-2 anti-nucleocapsid positive, not vaccinated

Group 3 (N=300)

SARS-CoV-2 anti-nucleocapsid negative, vaccinated

Group 4 (N=100)

SARS-CoV-2 anti-nucleocapsid negative, not vaccinated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare workers (clinical staff, practicing medical interns, cleaners, guards, food handlers, and receptionists) at the two hospitals and potentially participants from the general urban population in Jimma and Addis Ababa will be included. N=500 participants at each site (N=1000 in total) will be stratified according to their SARS CoV-2 sero-s and Covid-19 vaccination status at inclusion into 4 groups. We aim to target at least 30% representation of HCW's, respectively community participants for each study group.

You may qualify if:

• 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
• Willingness to provide blood samples by venipuncture for serology and immunological characterization
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michael Hoelscher: lead
• St. Paul's Hospital Millennium Medical College, Ethiopia: collaborator
• Jimma University: collaborator

Study Sites (2)

Department of Microbiology Immunology and Parasitology

Addis Ababa, Ethiopia

RECRUITING

Jimma University

Jimma, Ethiopia

RECRUITING

MeSH Terms

Conditions

COVID-19; COVID-19 breakthrough infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Arne Kroidl, MD

CONTACT

+49-89-4400; Arne.Kroidl@med.uni-muenchen.de

Rebecca Kisch

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Division of Infectious Diseases and Tropical Medicine, LMU Munich

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: November 10, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

ET (2)