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Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection (NPA-DC)

Karolinska Institute logo

Karolinska Institute

Status

Invitation-only

Conditions

Influenza B Virus Infection
SARS CoV 2 Infection
RSV Infection
Influenza A Infection

Study type

Observational

Funder types

Other

Identifiers

NCT06401720
2023-01776

Details and patient eligibility

About

The goal of this observational study is to understand immune responses to viral airway infection in adults, including the elderly. The main question(s) to answer is/are:

Why do some individuals acquire only asymptomatic or mild Influenza A virus (IAV) infection while others become severely ill and even succumb to the same disease?

Participants will be asked to donate samples when seeking health care for influenza-like symptoms or if hospitalized for IAV or SARS-CoV-2. Samples asked for are:

  • Blood sample by venepuncture
  • Blood sample by capillary sampling
  • Nasopharyngeal aspirate
  • Nasopharyngeal swab
  • Endotracheal tube aspirate
  • Nasal swab
  • Nasal curette
  • Breath Explor (sampling of expired air)

Researchers will compare obtained results with the same type of samples from healthy controls.

Full description

This observational study will specifically investigate different immunological parameters in blood and at the site of infection in patients with IAV symptoms or confirmed infection to understand parameters related to disease course. Blood and airway samples will be analyzed for immune cell subsets and their functionality, antibodies and other soluble mediators and linked to clinical data. Immune cells will be analyzed using multi-color flow cytometry, RNA sequencing, and in vitro functionality assays. Fluids (plasma, serum, supernatants from airway samples and cell culture supernatants) will be analyzed using ELISA (and or similar methods), proximity extension assay (Olink), etc.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Patients:

  • Influenza A like symptoms and/or
  • Confirmed airway infection

Exclusion Criteria Patients:

  • Current malignancies
  • Immunosuppressive treatment, not including/except hydrocortisone

Exclusion Criteria Controls:

  • Airway infection within the past four weeks
  • Ongoing antibiotic treatment
  • Immunosuppressive treatment

Trial design

800 participants in 2 patient groups

Patients
Description:
Patients with airway infection. Enrolled while seeking health care or when hospitalized.
Controls
Description:
Subjects without airway infection.

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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