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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07295535

Enrollment

Registered

2025-12-19

Start date

2025-09-01

Completion date

2027-09-30

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Immunocompromised Patients, Immuno-modulation, Immuno-suppression, Oncological Patients

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Measurement of cytokines produced by viral-specific nasal and peripheral T cells.	Assessed at 4 periodic intervals, approximately 45 days apart, based on clinical follow-up visits, starting from the beginning of enrollment up to 6 months.

Secondary

Measure	Time frame
Phenotypic characterisation of nasal and peripheral immune cells.	Measured at the time of enrollment.

Countries

Italy

Contacts

Primary ContactStefania Mantovani, MSc

s.mantovani@smatteo.pv.it0039 0382501808

Backup ContactSabrina Ottolini, MSc

s.ottolini@smatteo.pv.it0039 0382501808

Outcome results