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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Stefania Mantovani, MSc; Phone Number: 0039 0382501808; Email: s.mantovani@smatteo.pv.it
• Study Contact Backup: Name: Sabrina Ottolini, MSc; Phone Number: 0039 0382501808; Email: s.ottolini@smatteo.pv.it

Study Locations

• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Contact: Stefania Mantovani, MSc; Phone Number: 00390382501808; Email: s.mantovani@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The recruitment will take place at primary care clinic. Immunocompromised participants will be selected based on their regular visits, while healthy donors will be recruited through hospital and research networks.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Immunocompromised patients; 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; No underlying medical conditions declared, no clinical history of immunodeficiency or use of immunosuppressive medications.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Nasal Immunity Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No