COVID-19, Monkey Pox, Mucosal Immunity, SARS-CoV-2 Viraemia, Serum, Vaccination
Conditions
Keywords
Neutralizing antibodies, SARS-CoV-2, Monkeypox, Vaccination, Serum, Mucosal immunity
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.
Interventions
OTHERSample collection (blood and optional nasal swab)
Venous blood collection (2 tubes of 6 mL) and optional nasal swab at each visit. Aliquots analyzed for neutralizing activity against SARS-CoV-2 and MPXV using validated assays at Institut Pasteur
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Each participant receives the treatment (vaccine or monoclonal antibody) indicated by clinical practice. Samples (blood ± nasal swab) are collected at maximum 13 timepoints over 60 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactThierry PRAZUCK, Dr
Outcome results
None listed