Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435403
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-24
Brief Title:
SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Ethiopia
Sponsor:
Michael Hoelscher
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoVICIS
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 exposedvaccinated 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
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
Detailed Description:
The COVID-19 pandemic has severely impacted health systems interventions for infection control and resulting preventive public life restrictions In a recent study we determined high rates of previous SARS-CoV-2 infection in health care worker over 70 and communities in Ethiopia up to 60 with resulting potential natural acquired SARS-CoV-2 specific immunity In contrast to the situation in Europe the scale out of COVID-19 vaccination is however very low and currently there is a scarcity of COVID-19 vaccines available all over Africa Naturally acquired or vaccine induced SARS-CoV-2 immune responses have shown to protect against severe COVID-19 disease However immune responses are waning over time and new SARS-CoV-2 viral variants increasingly demonstrate immune escape properties Correlates of clinical immune protections are currently investigated including binding SARS-CoV-2 spike IgG or neutralizing antibody levels as well as cellular immune responses However threshold of immune protection are not yet defined that would guide the need of booster vaccinations including for individuals with natural acquired immunity There is evidence that vaccination regimens in those individuals could be abbreviated to single shot booster that would greatly economize challenged COVID-19 strategies in Africa
The CoVICIS is a network of European and African researcher who collaborate on the overall objective to investigate SARS-CoV-2 specific immune response and correlates of immune protection in the context of circulating SARS-CoV-2 viral variants In this affiliated study we aim to investigate these outcomes in Ethiopian health care worker and community members throughout a longitudinal prospective cohort study Participants stratified according to their SARS-CoV-2 infection and vaccination status will be followed-up in 3-monthly intervals To characterize SARS CoV-2 strain specific immune response SARS-CoV-2 Spike IgG in health care workers and general populations stratified by previous 1 SARS CoV-2 exposure SARS-CoV-2 anti-nucleocapsid antibody positive versus negative and 2 vaccination status at the Jimma Medical Center JMC and the St Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease Prevalence incidence and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments will be performed in 3-monthly intervals over a maximum period of 24 months
At each study visits immune responses including SARS-CoV-2 spike IgG and neutralizing antibody will be measured In addition SARS CoV-2-specific T cell responses will be studied in each of the study groups COVID-19 disease or SARS-CoV-2 infections will be assessed throughout the study by clinical history SARS-CoV-2 PCR diagnostics and seroconversion of SARS-CoV-2 anti-nucleocapsid antibody testing as appropriate In addition more in-depth analysis will be performed in a subset of stored blood samples at collaborating specialized laboratories in Germany and Switzerland including peptide array mapping T-cell assays and affinityavidity analysis against the ACE-II receptor We further aim to characterize circulating SARS CoV-2 strains from PCR isolates in the context of investigated immune responses Outcome results will be provided for computational analysis integrating models for immune protection Finally we will explore the feasibility and cost-effectiveness of abbreviated single shot COVID-19 vaccination for individuals with pre-existing natural immunity to assess COVID-19 vaccine strategies that are especially applicable in African settings
Findings from this study aim to help in guiding the current Covid-19 control strategy in Ethiopia It might also give the first insight about the dynamics and level of antibodies produced against SARS-CoV-2 in the Ethiopian population
The CoVICIS is a network of European and African researcher who collaborate on the overall objective to investigate SARS-CoV-2 specific immune response and correlates of immune protection in the context of circulating SARS-CoV-2 viral variants In this affiliated study we aim to investigate these outcomes in Ethiopian health care worker and community members throughout a longitudinal prospective cohort study Participants stratified according to their SARS-CoV-2 infection and vaccination status will be followed-up in 3-monthly intervals To characterize SARS CoV-2 strain specific immune response SARS-CoV-2 Spike IgG in health care workers and general populations stratified by previous 1 SARS CoV-2 exposure SARS-CoV-2 anti-nucleocapsid antibody positive versus negative and 2 vaccination status at the Jimma Medical Center JMC and the St Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease Prevalence incidence and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments will be performed in 3-monthly intervals over a maximum period of 24 months
At each study visits immune responses including SARS-CoV-2 spike IgG and neutralizing antibody will be measured In addition SARS CoV-2-specific T cell responses will be studied in each of the study groups COVID-19 disease or SARS-CoV-2 infections will be assessed throughout the study by clinical history SARS-CoV-2 PCR diagnostics and seroconversion of SARS-CoV-2 anti-nucleocapsid antibody testing as appropriate In addition more in-depth analysis will be performed in a subset of stored blood samples at collaborating specialized laboratories in Germany and Switzerland including peptide array mapping T-cell assays and affinityavidity analysis against the ACE-II receptor We further aim to characterize circulating SARS CoV-2 strains from PCR isolates in the context of investigated immune responses Outcome results will be provided for computational analysis integrating models for immune protection Finally we will explore the feasibility and cost-effectiveness of abbreviated single shot COVID-19 vaccination for individuals with pre-existing natural immunity to assess COVID-19 vaccine strategies that are especially applicable in African settings
Findings from this study aim to help in guiding the current Covid-19 control strategy in Ethiopia It might also give the first insight about the dynamics and level of antibodies produced against SARS-CoV-2 in the Ethiopian population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None