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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or lactating women.

Individuals unable to provide informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: Immunocompromised patients
Group B: Healthy Volunteers

Trial outcomes

Primary outcomes

1

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

1

Phenotypic characterisation of nasal and peripheral immune cells.

Time frame
Measured at the time of enrollment.

Other outcomes

Sponsors and contacts

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