Actively Recruiting
Analysis of the Specificity and Persistence of Nasal Immune Responses to Respiratory Viral Antigens in Immunocompromised and Healthy Cohorts
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-12-19
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying nasal mucosal immunity to respiratory viruses like SARS-CoV-2 in both immunocompromised adults and healthy volunteers aged 18 to 90. The study aims to understand how immune cell makeup and virus-specific responses differ between those with weakened immune systems due to medical conditions or treatments and those without such issues. This observational study compares these two groups to learn how immunodeficiency and related therapies affect immune responses. Participants are divided into two groups: immunocompromised patients with conditions like organ or stem cell transplants, ongoing immunosuppressive therapies, or genetic immunosuppression, and healthy volunteers with no underlying medical conditions or history of immune problems. There are no interventional treatments; instead, researchers collect data during routine clinical visits over approximately six months. During the study, participants undergo assessments at four periodic intervals roughly 45 days apart, starting from enrollment. These include measuring cytokines produced by nasal and blood T cells specific to viruses, as well as characterizing immune cells at enrollment. The study tracks immune responses over time to better understand how immunity persists or changes. Participants' safety and informed consent are ensured throughout the observation period, which lasts about six months from the first visit.
CONDITIONS
Brief Title
Analysis of the Specificity and Persistence of Nasal Immune Responses to Respiratory Viral Antigens in Immunocompromised and Healthy Cohorts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Aged between 18 and 90 years.
- For healthy volunteers: no underlying medical conditions, no history of immunodeficiency, and no use of immunosuppressive medications.
- For immunocompromised patients: medical conditions or treatments causing significant immune system impairment, including organ or stem cell transplants, ongoing immunosuppressive therapies, or documented genetic immunosuppression.
You will not qualify if you...
- Pregnant or lactating women.
- Individuals unable to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo phenotypic characterization of nasal and peripheral immune cells at enrollment.
1 visit (in-person)
Duration - Up to 6 months
Participants are monitored through periodic clinical follow-up visits to measure cytokines produced by viral-specific nasal and peripheral T cells.
4 visits approximately 45 days apart
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
S
Stefania Mantovani, MSc
S
Sabrina Ottolini, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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