Neutralizing Power of Serum Antibodies - 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Persons under guardianship or curatorship
Persons under legal protection,
Persons persons deprived of liberty
Persons not affiliated to a social security scheme
Trial design
Design model
Single group
Treatments tested in this trial
Sample collection (blood and optional nasal swab)
Other interventionVenous 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
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Participants receiving vaccines and/or monoclonal antibodiesOther 1 intervention
Trial outcomes
Primary outcomes
1
Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time
S-Fuse and S-Flow tests performed on collected serum samples at each visit
Time frame
Up to 60 monthsSecondary outcomes
1
Mucosal (nasal) neutralizing antibody response and MPXV serology over time
Nasal antibody neutralization (anti-MPX) and serum MPXV neutralization assessed using validated Pasteur Institute protocols
Time frame
Up to 60 months2
Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time
Nasal antibody neutralization (anti-SARS-CoV-2) and serum SARS-CoV-2 neutralization assessed using validated Pasteur Institute protocols
Time frame
Up to 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov