An interventional study of Sample collection (blood and optional nasal swab) in COVID-19, SARS-CoV-2 Viraemia and Monkey Pox, sponsored by Centre Hospitalier Régional d'Orléans. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Basic science
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.
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 30 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 132 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Sample 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
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 months
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 months
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 months
Started Aug 2025 (actual). Primary completion is estimated for Aug 2030, 60 months after the start.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's planned 60 months is above that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
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