Study of the Neutralizing Power of Serum Antibodies - 2 (PNAS-2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Participants receiving vaccines and/or monoclonal antibodies
Participants receive standard-of-care SARS-CoV-2 and/or MPXV vaccines or monoclonal antibodies. This study does not assign the treatment but collects biosamples to assess antibody response.
Intervention: Sample collection (blood and optional nasal swab) (Other)
Outcomes
Primary Outcomes
Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time
Time Frame: Up to 60 months
S-Fuse and S-Flow tests performed on collected serum samples at each visit
Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time
Time Frame: Up to 60 months
S-Fuse and S-Flow tests performed on collected serum samples at each visit
Secondary Outcomes
- Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time(Up to 60 months)
- Mucosal (nasal) neutralizing antibody response and MPXV serology over time(Up to 60 months)
- Mucosal (nasal) neutralizing antibody response and MPXV serology over time(Up to 60 months)
- Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time(Up to 60 months)