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

Not Applicable

Terminated

• Conditions: SARS CoV 2 Infection; COVID-19

• 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.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2022-12-01
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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