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

NCT07295535 | Recruiting

• 1 other identifier: Nasal Immunity Study
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Phenotypic characterisation of nasal and peripheral immune cells.

  Measured at the time of enrollment.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasal Swabs, Isolated PBMCs and Serum.

Central Study Contacts

Stefania Mantovani, MSc

CONTACT

0039 0382501808; s.mantovani@smatteo.pv.it

Sabrina Ottolini, MSc

CONTACT

0039 0382501808; s.ottolini@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)