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

Centre Hospitalier Régional d'Orléans

Status: Enrolling

Conditions: COVID-19; SARS CoV 2 Infection

Treatments: Other: Collection of biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT05315583

CHRO-2022-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Group with collection of biological samples

Other group

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.

Treatment:

Other: Collection of biological samples