Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection

NCT ID: NCT06401720

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with airway infection. Enrolled while seeking health care or when hospitalized.

No interventions assigned to this group

Controls

Subjects without airway infection.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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


* Airway infection within the past four weeks
* Ongoing antibiotic treatment
* Immunosuppressive treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anna Smed Sörensen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Smed Sörensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Södertälje Sjukhus

Södertälje, , Sweden

Site Status

Familjeläkarna

Stockholm, , Sweden

Site Status

Haga Närakut

Stockholm, , Sweden

Site Status

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Site Status

Sabbatsbergs sjukhus

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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 helper cells correlates with severe COVID-19. Nat Commun. 2023 Apr 15;14(1):2164. doi: 10.1038/s41467-023-37835-9.

Reference Type BACKGROUND
PMID: 37061513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36752598 (View on PubMed)

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 rapidly but reappear after SARS-CoV-2 vaccination. JCI Insight. 2021 Nov 22;6(22):e151463. doi: 10.1172/jci.insight.151463.

Reference Type BACKGROUND
PMID: 34665783 (View on PubMed)

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):e144734. doi: 10.1172/JCI144734.

Reference Type BACKGROUND
PMID: 33492309 (View on PubMed)

Related Links

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Other Identifiers

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2023-01776

Identifier Type: -

Identifier Source: org_study_id

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