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
This trial accepts healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 4 trial groupsGroup A: Group 1 (N=300)
Group B: Group 2 (N=300)
Group C: Group 3 (N=300)
Group D: Group 4 (N=100)
Trial outcomes
Primary outcomes
1
Difference of antibody levels between study groups by month 12
Antibody levels will be compared between study groups by month 12
Time frame
12 months2
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
Time frame
12 months3
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
Time frame
24 monthsSecondary outcomes
1
Difference of antibody levels between groups by month 6, 18 and 24
Antibody levels will be compared between study groups by month 6, 18, 24
Time frame
24 months2
Antibody levels after single 1st vaccination in previously infected persons
Antibody levels will be compared after single 1st vaccination in previously infected persons
Time frame
24 months3
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
The 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 will be compared
Time frame
24 months4
Prevalence and distribution of circulating SARS-CoV-2 variants around baseline and during the study period
Prevalence and distribution of circulating SARS-CoV-2 variants around baseline and during the study period
Time frame
24 monthsOther outcomes
1
Difference of neutralizing antibodies in a subset of participants by study groups at baseline and subsequent time points
Comparing neutralizing antibodies in a subset of participants by study groups at baseline and subsequent time points
Time frame
24 months2
Recognition of SARS-CoV-2 specific peptide in a subset of participants by study groups at baseline and subsequent time points
Recognition of SARS-CoV-2 specific peptide in a subset of participants by study groups at baseline and subsequent time points
Time frame
24 months3
Determination of upper respiratory viral load in subjects with (re)infection
Determination of upper respiratory viral load in subjects with (re)infection
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael Hoelscher
Lead sponsor
Ludwig-Maximilians - University of Munich
Sponsor institution
St. Paul's Hospital Millennium Medical College, Ethiopia
Collaborator
Jimma University
Collaborator
Source ClinicalTrials.gov