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

NCT ID: NCT07295535

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Healthy Volunteers

No underlying medical conditions declared, no clinical history of immunodeficiency or use of immunosuppressive medications.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Stefania Mantovani

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefania Mantovani, MSc

Role: CONTACT

Phone: 0039 0382501808

Email: [email protected]

Sabrina Ottolini, MSc

Role: CONTACT

Phone: 0039 0382501808

Email: [email protected]

Facility Contacts

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Stefania Mantovani, MSc

Role: primary

Other Identifiers

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Nasal Immunity Study

Identifier Type: -

Identifier Source: org_study_id