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NCT Number: NCT07295535

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Stefania Mantovani, MSc

CONTACT

[email protected]

00390382501808

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina Ottolini, MSc

CONTACT

[email protected]

0039 0382501808

Stefania Mantovani, MSc

CONTACT

[email protected]

0039 0382501808

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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