Analysis of the Specificity and Persistence of Nasal Immune Responses to Respiratory Viral Antigens in Immunocompromised and Healthy Cohorts
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Measurement of cytokines produced by viral-specific nasal and peripheral T cells.
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Measurement of cytokines produced by viral-specific nasal and peripheral T cells.
Time Frame: 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
- Phenotypic characterisation of nasal and peripheral immune cells.(Measured at the time of enrollment.)
Investigators
Stefania Mantovani
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia