Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection

• Conditions: SARS CoV 2 Infection; Influenza A Infection; Influenza B Virus Infection; RSV Infection

• Registration Number: NCT06401720
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-04-26
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of immune cells	Samples are taken at several different occasions when the patient is experiencing an airway infection and during convalescence. Samples are taken during a time frame of up to 6 months.	Flow cytometric analysis of white blood cell phenotype and frequency in PBMC, nasopharyngeal aspirate, nasopharyngeal swab, nasal swab, nasal curette, and endotracheal tube aspirate samples.

Trial Locations

Locations (5)

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Familjeläkarna; 🇸🇪 Stockholm, Sweden

Sabbatsbergs sjukhus; 🇸🇪 Stockholm, Sweden

Haga Närakut; 🇸🇪 Stockholm, Sweden

Södertälje Sjukhus; 🇸🇪 Södertälje, Sweden