COVID-19PNAS-2NCT07085611
Neutralizing Power of Serum Antibodies - 2
A study testing Sample collection (blood and optional nasal swab) in people with COVID-19 and SARS-CoV-2 Viraemia, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2 Viraemia, Monkey Pox
- What is being tested?
- Sample collection (blood and optional nasal swab)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Aug 2025to 11 Jul 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Orléans
Orléans, 45067
Thierry PRAZUCK, Dr, 0238229593 ext. +33, thierry.prazuck@chu-orleans.fr
Thierry PRAZUCK, Dr
About this study
Official title: Study of the Neutralizing Power of Serum Antibodies - 2 (PNAS-2)
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.
Read the 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.
- Conditions
- COVID-19, SARS-CoV-2 Viraemia, Monkey Pox, Vaccination, Serum, Mucosal Immunity
- Being tested
- Sample collection (blood and optional nasal swab)
- Keywords
- Neutralizing antibodies, SARS-CoV-2, Monkeypox, Vaccination, Serum, Mucosal immunity
- Medical subject headings
- COVID-19, Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collection (blood and optional nasal swab)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
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving vaccines and/or monoclonal antibodies | Other | 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. Receives: Other: Sample collection (blood and optional nasal swab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 60 months
Secondary outcomes (2)
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
Measured: 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
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start22 Aug 2025
- Primary completion22 Aug 2030 (estimated)
- Study completion11 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PRAZUCK, Dr, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085611
- Sponsor's protocol ID
- CHUO-2024-22
- Acronym
- PNAS-2
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32817357Planas 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.
PubMed 33772244Hubert 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.
PubMed 37196656
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Neutralizing Power of Serum Antibodies - 2 (PNAS-2)
- ClinicalTrials.gov ID
- NCT07085611
- Acronym / sponsor ID
- PNAS-2 / CHUO-2024-22
- Conditions
- COVID-19, SARS-CoV-2 Viraemia, Monkey Pox, Vaccination, Serum, Mucosal Immunity
- Keywords
- Neutralizing antibodies, SARS-CoV-2, Monkeypox, Vaccination, Serum, Mucosal immunity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 22 Aug 2030 (estimated)
- Study completion
- 11 Jul 2035 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants receiving vaccines and/or monoclonal antibodies | Other | Other: Sample collection (blood and optional nasal swab)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Participants receiving vaccines and/or monoclonal antibodies |
Primary outcome
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
2 secondary outcomes
Mucosal (nasal) neutralizing antibody response and MPXV serology over time
Time frame: Up to 60 months
Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time
Time frame: Up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 32817357Grzelak 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.
- Background: PubMed 33772244Planas 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.
- Background: PubMed 37196656Hubert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry PRAZUCK, Dr principal investigator
CHU Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sample collection (blood and optional nasal swab) in people with COVID-19 and SARS-CoV-2 Viraemia, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry PRAZUCK, Dr (0238229593 ext. +33, thierry.prazuck@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085611, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.