COVID-19, SARS CoV 2 Infection
Conditions
Keywords
COVID-19, Vaccines, Monoclonal antibodies, Neutralization, Serum, Nasal mucosa
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.
Interventions
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.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the serum humoral response | Day 0 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the mucosal humoral response | Day 0 | 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) |
| Proportion of participants developing COVID-19 infection after these treatments | Day 0 | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. |
Countries
France
Outcome results
None listed