Neutralizing Power of Serum Antibodies - 2

Not Applicable

Not yet recruiting

• Conditions: COVID-19; SARS-CoV-2 Viraemia; Monkey Pox; Vaccination; Serum; Mucosal Immunity

• Registration Number: NCT07085611
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

Severe forms of COVID-19 and Monkeypox affect immunocompromised and comorbid individuals. Vaccination and monoclonal antibody therapies induce neutralizing antibodies. This neutralizing power is recognized as a correlate of protection against a new infection. This study aims to describe the neutralizing power of serum and nasal antibodies over time, in relation to SARS-CoV-2 and MPXV vaccines or treatments received.

Detailed Description

This is a monocentric, longitudinal, descriptive study aiming to measure and describe the evolution of the humoral immune response (serum and nasal) to SARS-CoV-2 and MPXV, following any vaccination or administration of monoclonal antibodies. Samples are collected over a maximum 60-month period per participant to assess the durability of neutralizing activity.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Study Start: 2025-07-31
• Primary Completion: 2030-07-11
• Study Completion: 2035-07-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults (≥18 years)
• Patients receiving or scheduled to receive anti-SARS-CoV-2 and/or anti-MPXV vaccines or monoclonal antibodies
• Patients have provided written informed consent

Exclusion Criteria

• Persons under guardianship or curatorship
• Persons under legal protection,
• Persons persons deprived of liberty
• Persons not affiliated to a social security scheme
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time	Up to 60 months	S-Fuse and S-Flow tests performed on collected serum samples at each visit

Secondary Outcome Measures

Name	Time	Method
Mucosal (nasal) neutralizing antibody response and MPXV serology over time	Up to 60 months	Nasal antibody neutralization (anti-MPX) and serum MPXV neutralization assessed using validated Pasteur Institute protocols
Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time	Up to 60 months	Nasal antibody neutralization (anti-SARS-CoV-2) and serum SARS-CoV-2 neutralization assessed using validated Pasteur Institute protocols

Trial Locations

Locations (1)

CHU Orléans; 🇫🇷 Orléans, France