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Neutralizing Power of Serum Antibodies - 2

NCT ID: NCT07085611

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-22

Study Completion Date

2035-07-11

Brief Summary

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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

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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.

Conditions

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COVID-19 SARS-CoV-2 Viraemia Monkey Pox Vaccination Serum Mucosal Immunity

Keywords

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Neutralizing antibodies SARS-CoV-2 Monkeypox Vaccination Serum Mucosal immunity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Sample collection (blood and optional nasal swab)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry PRAZUCK, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Orléans

Locations

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CHU Orléans

Orléans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thierry PRAZUCK, Dr

Role: CONTACT

Phone: 0238229593

Email: [email protected]

Facility Contacts

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Thierry PRAZUCK, Dr

Role: primary

References

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Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17.

Reference Type BACKGROUND
PMID: 32817357 (View on PubMed)

Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26.

Reference Type BACKGROUND
PMID: 33772244 (View on PubMed)

Hubert M, Guivel-Benhassine F, Bruel T, Porrot F, Planas D, Vanhomwegen J, Wiedemann A, Burrel S, Marot S, Palich R, Monsel G, Diombera H, Gallien S, Lopez-Zaragoza JL, Vindrios W, Taieb F, Fernandes-Pellerin S, Delhaye M, Laude H, Arowas L, Ungeheuer MN, Hocqueloux L, Pourcher V, Prazuck T, Marcelin AG, Lelievre JD, Batejat C, Levy Y, Manuguerra JC, Schwartz O. Complement-dependent mpox-virus-neutralizing antibodies in infected and vaccinated individuals. Cell Host Microbe. 2023 Jun 14;31(6):937-948.e4. doi: 10.1016/j.chom.2023.05.001. Epub 2023 May 5.

Reference Type BACKGROUND
PMID: 37196656 (View on PubMed)

Other Identifiers

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CHUO-2024-22

Identifier Type: -

Identifier Source: org_study_id