Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies

Study Overview
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Brief Summary
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Natural infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). This neutralizing power is recognized as a correlate of protection against a (new) infection. This study aims to measure the neutralizing power of the serum of patients (whether or not they have been infected with SARS-CoV-2) according to the treatments and/or vaccines received and to assess the durability of this power in the time.

Detailed Description
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Infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). This neutralizing power is recognized as a correlate of protection against (new) infection. The purpose of this study is to measure the neutralizing power of the serum of patients (whether or not they have been infected with SARS-CoV-2) depending on the treatments and/or vaccines received and to assess the durability of this power over time. The main objective is to measure and describe the evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies). The secondary objectives are: to measure and describe the antibody response at the level of the nasal mucosa (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies, collected by means of a nasal swab) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies SARS-CoV-2. to describe the incidence of COVID in the study patients.

Official Title
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Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies

Conditions
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COVID-19, SARS CoV 2 Infection

Intervention / Treatment
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* Other: Collection of biological samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult volunteers for the study, having received or about to receive any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies). Having given their consent to participate in the study Exclusion Criteria: Minors Pregnant women Persons under tutorship or curatorship Protected adults Person under legal protection Person not affiliated to a social security scheme Persons unable to express their consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Collection of biological samples (Day 0, D3, D15, Month 1, M2, M3, M4, M5, M6, M9, M12, M18) with associated data for the study of the kinetics of antibodies against COVID-19. All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group with collection of biological samples<br>All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute. | Other: Collection of biological samples<br>* All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 0 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 0 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 3 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 3 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 15 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 15 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 1 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 1 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 2 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 2 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 3 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 3 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 4 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 4 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 5 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 5 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 6 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 6 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 9 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 9 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 12 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 12 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 18 | 
| Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 0 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 0 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 3 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 3 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Day 15 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Day 15 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 1 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 1 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 2 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 2 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 3 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 3 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 4 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 4 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 5 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 5 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 6 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 6 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 9 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 9 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 12 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 12 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Flow in BAU/ml (Binding Antibody Unit/milliliter) | Month 18 | 
| Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies. S-Fuse in ED50 (Effective Dilution 50% titers) | Month 18 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 0 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 3 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 15 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 1 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 2 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 3 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 4 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 5 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 6 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 9 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 12 | 
| Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Vaccines, Monoclonal antibodies, Neutralization, Serum, Nasal mucosa