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

Centre Hospitalier Régional d'Orléans

Status: Not yet enrolling

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

Treatments: Other: Sample collection (blood and optional nasal swab)

Study type: Interventional

Funder types: Other

Identifiers

NCT07085611

CHUO-2024-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Participants receiving vaccines and/or monoclonal antibodies

Other group

Description:

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.

Treatment:

Other: Sample collection (blood and optional nasal swab)