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NCT Number: NCT07085611

Neutralizing Power of Serum Antibodies - 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.

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Key information

Conditions

COVID-19 Animal Diseases Coronaviridae Infections Coronavirus Infections DNA Virus Infections Infections Lung Diseases Monkey Pox Mpox, Monkeypox Mucosal Immunity Nidovirales Infections Pneumonia Pneumonia, Viral Poxviridae Infections Primate Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rodent Diseases SARS-CoV-2 Viraemia Serum Vaccination Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Orléans

Orléans, 45067, France

Location status: Recruiting

Location contact

Thierry PRAZUCK, Dr

CONTACT

[email protected]

0238229593 ext. +33

Thierry PRAZUCK, Dr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Mucosal (nasal) neutralizing antibody response and MPXV serology over time

    Time frame: Up to 60 months

    Nasal antibody neutralization (anti-MPX) and serum MPXV neutralization assessed using validated Pasteur Institute protocols

  2. Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time

    Time frame: Up to 60 months

    Nasal antibody neutralization (anti-SARS-CoV-2) and serum SARS-CoV-2 neutralization assessed using validated Pasteur Institute protocols

Study contacts

Contact information is provided by the study sponsor or research team.

Thierry PRAZUCK, Dr

CONTACT

[email protected]

0238229593 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: PNAS-2

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Jul 25, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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