Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
- Conditions
- SARS CoV 2 InfectionCOVID-19
- Interventions
- Other: Collection of biological samples
- Registration Number
- NCT05315583
- Lead Sponsor
- Centre Hospitalier Régional d'Orléans
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group with collection of biological samples Collection of biological samples 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 Measures
Name Time Method Evolution of the serum humoral response Month 18 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
Name Time Method Evolution of the mucosal humoral response Month 18 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 Month 18 Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.
Trial Locations
- Locations (1)
Centre Hospitalier Régional d'Orléans, France
🇫🇷Orléans, France