Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection

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.

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Key information

Conditions

Influenza A Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza B Virus Infection Lung Diseases Mononegavirales Infections Nidovirales Infections Paramyxoviridae Infections Pneumonia Pneumonia, Viral Pneumovirus Infections RNA Virus Infections RSV Infection Respiratory Syncytial Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS CoV 2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Familjeläkarna, Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

Frequency of immune cells

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Respiratory Immune Responses in Human Influenza Virus Infection Across Age to Understand What Dictates Disease Severity

Acronym: NPA-DC

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2030
First posted: May 7, 2024
Registry last updated: May 7, 2024

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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