Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection

NCT06401720 | Enrolling By Invitation

• 1 other identifier: 2023-01776
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Influenza A virus (IAV); Influenza B virus (IBV); SARS CoV 2; respiratory syncytial virus (RSV); immunology; age-related differences

Outcome Measures

Primary Outcomes (1)

• Frequency of immune cells

  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.

  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.

Study Arms (2)

Patients

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

Controls

Subjects without airway infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are from primary care clinics, hospitalized, or household contacts of subjects seeking health care at a primary care clinic. The study population is included in the greater Stockholm area within the Region Stockholm health care region.

You may qualify if:

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

You may not qualify if:

• Current malignancies
• Immunosuppressive treatment, not including/except hydrocortisone
• Airway infection within the past four weeks
• Ongoing antibiotic treatment
• Immunosuppressive treatment

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (5)

Södertälje Sjukhus

Södertälje, Sweden

Location

Familjeläkarna

Stockholm, Sweden

Location

Haga Närakut

Stockholm, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Sabbatsbergs sjukhus

Stockholm, Sweden

Location

Related Publications (4)

• 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.

  PMID: 37061513 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34665783 BACKGROUND

• 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.

  PMID: 33492309 BACKGROUND

Related Links

• Home page of the research group performing the study

Biospecimen

Retention: SAMPLES WITH DNA

Cryopreserved PBMCs. Plasma. Serum. Nasopharyngeal aspirate liquid. Endotracheal tube aspirate liquid. Nasal swab liquid. Nasopharyngeal swab liquid. Nasal curette liquid. Breath Explor devices.

MeSH Terms

Conditions

COVID-19; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Study Officials

• Anna Smed Sörensen, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 7, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)