Menu
Recruiting NCT07085611

Neutralizing Power of Serum Antibodies - 2

No phase Interventional COVID-19 SARS-CoV-2 Viraemia Monkey Pox Vaccination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sample collection (blood and optional nasal swab).
Who it may be relevant to
Registry conditions: COVID-19, SARS-CoV-2 Viraemia, Monkey Pox, Vaccination. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study of the Neutralizing Power of Serum Antibodies - 2 (PNAS-2)

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time [Time frame: Up to 60 months]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU Orléans — Orléans

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, PMID 32817357
  • 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 PMID 33772244
  • 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-neu PMID 37196656

Identifiers

NCT: NCT07085611 · CHUO-2024-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗