Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies (PNAS)
Primary Purpose
COVID-19, SARS CoV 2 Infection
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of biological samples
Sponsored by
About this trial
This is an interventional basic science trial for COVID-19 focused on measuring COVID-19, Vaccines, Monoclonal antibodies, Neutralization, Serum, Nasal mucosa
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Régional d'Orléans, FranceRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Group with collection of biological samples
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05315583
First Posted
March 16, 2022
Last Updated
December 27, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT05315583
Brief Title
Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
Acronym
PNAS
Official Title
Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS CoV 2 Infection
Keywords
COVID-19, Vaccines, Monoclonal antibodies, Neutralization, Serum, Nasal mucosa
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group with collection of biological samples
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Collection of biological samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Day 0
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Day 0
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Day 3
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Day 3
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Day 15
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Day 15
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 1
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 1
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 2
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 2
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 3
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 3
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 4
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 4
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 5
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 5
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 6
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 6
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 9
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 9
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 12
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 12
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 18
Title
Evolution of the serum humoral response
Description
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)
Time Frame
Month 18
Secondary Outcome Measure Information:
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Day 0
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Day 0
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Day 3
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Day 3
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Day 15
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Day 15
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 1
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 1
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 2
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 2
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 3
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 3
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 4
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 4
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 5
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 5
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 6
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 6
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 9
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 9
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 12
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 12
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 18
Title
Evolution of the mucosal humoral response
Description
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)
Time Frame
Month 18
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Day 0
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Day 3
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Day 15
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 1
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 2
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 3
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 4
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 5
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 6
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 9
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 12
Title
Proportion of participants developing COVID-19 infection after these treatments
Description
Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Time Frame
Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent HOCQUELOUX, Dr
Phone
0033238229588
Email
laurent.hocqueloux@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry PRAZUCK, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional d'Orléans, France
City
Orléans
ZIP/Postal Code
45000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry PRAZUCK, MD
Email
thierry.prazuck@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Thierry PRAZUCK, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
32817357
Citation
Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17.
Results Reference
background
PubMed Identifier
33772244
Citation
Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26.
Results Reference
background
Learn more about this trial
Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
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