Analysis of the Specificity and Persistence of Nasal Immune Responses to Respiratory Viral Antigens in Immunocompromised and Healthy Cohorts

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Oncological Patients; Immuno-suppression; Healthy Subjects; Immuno-modulation; Immunocompromised Patients

Study type: Observational

Funder types: Other

Identifiers

NCT07295535

Nasal Immunity Study

Details and patient eligibility

About

The goal of this observational study is to characterize nasal mucosal immunity to respiratory viruses, such as SARS-CoV-2, in immunocompromised individuals and healthy volunteers.

The study involves adults of any sex, between 18 and 90 years old, including both immunocompromised patients with medical conditions or treatments that can affect immune cell functions and healthy controls with no underlying medical conditions declared, no clinical history of immunodeficiency or use of immunosuppressive medications.

Researchers will compare immunocompromised participants to healthy volunteers to determine how underlying immunodeficiency and related treatments affect immune cell composition and virus-specific responses.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent: Participants must have signed an informed consent form.
• Age Range: Participants aged between 18 and 90 years.
• Healthy Immunocompetent Donors: no underlying medical conditions declared, no clinical history of immunodeficiency or use of immunosuppressive medications.
• Immunocompromised Patients: subjects with medical conditions or treatments associated with significant impairment of the immune system. This may include organ or stem cell transplants, ongoing immunosuppressive therapies, documented genetic immunosuppression.

Exclusion criteria

• Pregnant or lactating women.
• Individuals unable to provide informed consent

Trial design

40 participants in 2 patient groups

Immunocompromised patients

Description:

Participants with medical conditions or treatments associated with significant impairment of the immune system. This may include organ or stem cell transplants, ongoing immunosuppressive therapies, documented genetic immunosuppression.

Healthy Volunteers

Description:

No underlying medical conditions declared, no clinical history of immunodeficiency or use of immunosuppressive medications.