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Enrolling by invitation NCT06401720

Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Influenza A Infection, Influenza B Virus Infection, SARS CoV 2 Infection, RSV Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 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.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Sweden · 5 centers
  • Södertälje Sjukhus — Södertälje
  • Familjeläkarna — Stockholm
  • Haga Närakut — Stockholm
  • Karolinska Universitetssjukhuset — Stockholm
  • Sabbatsbergs sjukhus — Stockholm

Publications

  • Yu M, Charles A, Cagigi A, Christ W, Osterberg B, Falck-Jones S, Azizmohammadi L, Ahlberg E, Falck-Jones R, Svensson J, Nie M, Warnqvist A, Hellgren F, Lenart K, Arcoverde Cerveira R, Ols S, Lindgren G, Lin A, Maecker H, Bell M, Johansson N, Albert J, Sundling C, Czarnewski P, Klingstrom J, Farnert A, Lore K, Smed-Sorensen A. Delayed generation of functional virus-specific circulating T follicular PMID 37061513
  • Vangeti S, Falck-Jones S, Yu M, Osterberg B, Liu S, Asghar M, Sonden K, Paterson C, Whitley P, Albert J, Johansson N, Farnert A, Smed-Sorensen A. Human influenza virus infection elicits distinct patterns of monocyte and dendritic cell mobilization in blood and the nasopharynx. Elife. 2023 Feb 8;12:e77345. doi: 10.7554/eLife.77345. PMID 36752598
  • Cagigi A, Yu M, Osterberg B, Svensson J, Falck-Jones S, Vangeti S, Ahlberg E, Azizmohammadi L, Warnqvist A, Falck-Jones R, Gubisch PC, Odemis M, Ghafoor F, Eisele M, Lenart K, Bell M, Johansson N, Albert J, Salde J, Pettie DD, Murphy MP, Carter L, King NP, Ols S, Normark J, Ahlm C, Forsell MN, Farnert A, Lore K, Smed-Sorensen A. Airway antibodies emerge according to COVID-19 severity and wane rapi PMID 34665783
  • Falck-Jones S, Vangeti S, Yu M, Falck-Jones R, Cagigi A, Badolati I, Osterberg B, Lautenbach MJ, Ahlberg E, Lin A, Lepzien R, Szurgot I, Lenart K, Hellgren F, Maecker H, Salde J, Albert J, Johansson N, Bell M, Lore K, Farnert A, Smed-Sorensen A. Functional monocytic myeloid-derived suppressor cells increase in blood but not airways and predict COVID-19 severity. J Clin Invest. 2021 Mar 15;131(6):e PMID 33492309

Identifiers

NCT: NCT06401720 · 2023-01776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗