Neutralizing Power of Serum Antibodies - 2
PNAS-2
Study of the Neutralizing Power of Serum Antibodies - 2 (PNAS-2)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Aug 2025
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2025
CompletedFirst Posted
Study publicly available on registry
July 25, 2025
CompletedStudy Start
First participant enrolled
August 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 11, 2035
December 19, 2025
December 1, 2025
5 years
July 17, 2025
December 12, 2025
Conditions
Keywords
Outcome Measures
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
Up to 60 months
Secondary Outcomes (2)
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
Study Arms (1)
Participants receiving vaccines and/or monoclonal antibodies
OTHERParticipants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Orléans
Orléans, 45067, France
Related Publications (3)
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.
PMID: 32817357BACKGROUNDPlanas 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.
PMID: 33772244BACKGROUNDHubert 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.
PMID: 37196656BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry PRAZUCK, Dr
CHU Orléans
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2025
First Posted
July 25, 2025
Study Start
August 22, 2025
Primary Completion (Estimated)
August 22, 2030
Study Completion (Estimated)
July 11, 2035
Last Updated
December 19, 2025
Record last verified: 2025-12