- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04469634
Are SARS-CoV-2 Specific Antibodies a Correlate for Protection? (ImmCoV)
March 3, 2023 updated by: Institute of Tropical Medicine, Belgium
The objectives of this study are (1) to determine the ex vivo neutralizing capacity and the longevity of SARS-CoV-2-specific Ab responses and (2) to measure the memory B-cell responses in a cohort of health care workers (HCW) recovering from severe, mild or asymptomatic infection.
By focusing on HCW, a population that is at risk for re-infection during a second epidemic wave, the correlation between nAb levels and protection is investigated.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
SARS-CoV-2 has spread at an unprecedented speed and scale since January 2020.
Since then, Belgium has been confronted with >60.000 diagnosed cases and likely many more undiagnosed with mild or no symptoms.
The true seroprevalence of SARS-CoV-2 in the Belgian population is not known, yet increasing confidence about the performance of several serological assays paves the way to large-scale serosurveys.
These studies will be crucial in assessing population immunity and evaluating the risk of re-infection.
The first, smaller-scaled, antibody surveys report a range of seroprevalences, i.e.
Germany (14%), The Netherlands (4%), USA (2.49-4.16%)
and Belgium (4.7-6.9%).
These studies suffer from conceptual and technical flaws yet are used for easing lockdown measures.
A major limitation is that antibody (Ab) capture assays measure exposure to SARS-CoV-2, rather than subsequent protection, which requires assessment of the quality of the Abs including their capacity to neutralize the virus.
Also the Ab levels required for protection and their duration are yet unknown.
The proposed project aims to address these pertinent questions in a population at risk of re-infection during a second epidemic wave.
Sero-neutralisation assays are regarded the gold standard method to measure ex vivo Ab neutralising activity against viruses, including SARS-CoV-2.
A recent Chinese study, using a pseudovirus neutralisation assay, found that nAbs are detected from day 10-15 after onset of disease and that younger patients typically have lower levels of nAbs compared to middle-aged and elderly patients.
Importantly, in about 1 out of 3 patients the nAb titers were low and in 10 young patients nAbs were absent.
A pseudovirus is an imperfect model for SARS-CoV-2 because of the non-natural embedding of Spike protein in the pseudovirions and differences in glycosylation.
In this study, a whole virus neutralisation assay will be used that was recently validated using a panel of SARS-CoV-2 convalescent sera in the lab of the Principal Investigator.
Preliminary results of the study team show a rapid decline in nAb titer within 15-36d after diagnosis in 4/11 patients, while IgG and IgA remain steady and high in ELISA.
Older studies with SARS-CoV-1 showed declining IgM and IgA antibody titers within 6 months, declining IgG titers after 1y, and a complete lack of antigen-specific peripheral memory B-cell (MBC) responses after recovery.
Measuring only circulating Abs can be misleading as it excludes the detection of the MBC pool, which can exist in the absence of detectable serum Ab levels and is a pre-requisite to maintain protective immunity in the long term.
Upon re-encounter with the antigen, MBC can rapidly differentiate to produce Abs.
So far, little is known about humoral immune responses against SARS-CoV-2 and their contribution to protection.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antwerpen, Belgium, 2000
- University Hospital Antwerp
-
Hasselt, Belgium
- Jessa Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be diagnosed (PCR+) with COVID-19 between March-May 2020
- Be a permanent employee (HCW: nurse, physician, paramedical) of the study hospital
- Agree to complete a short questionnaire and be sampled 4 tubes of heparin whole blood every 3 months over a one-year period
- Have given their informed consent to participate
Exclusion Criteria:
- Persons in serious clinical condition, incompatible with the informed consent procedure
- Pregnant women
- Persons that have not been diagnosed with COVID-19
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: antibody response and memory B-cell
Regular blood draws to measure antibody responses and memory B-cell responses Regular swab collection to test for re-infection
|
Assessing antibody responses, neutralizing capacity and memory B-cell function and their contribution to protection against re-infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibody levels over time
Time Frame: 12 months
|
Antibody levels over time
|
12 months
|
Antibody neutralizing capacity
Time Frame: 12 months
|
Antibody neutralizing capacity
|
12 months
|
Memory B-cell function
Time Frame: 12 months
|
Memory B-cell function
|
12 months
|
Antibody-dependent enhancement
Time Frame: 12 months
|
Antibody-dependent enhancement
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-infection with SARS-CoV2
Time Frame: 12 months
|
Re-infection with SARS-CoV2
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin K. Ariën, PhD, Institute of Tropical Medicine Antwerp
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2020
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
July 13, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (Actual)
July 14, 2020
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 3, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1412/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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