Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection

SARS CoV 2 Infection Clinical Trial

— NPA-DC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06401720
• Other study ID #: 2023-01776
• Status: Enrolling by invitation
• Start date: January 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Herpesviridae Infections
• Infections
• Influenza A Infection
• Influenza B Virus Infection
• Influenza, Human
• Respiratory Syncytial Virus Infections
• RSV Infection
• Virus Diseases

Locations

Country	Name	City	State
Sweden	Södertälje Sjukhus	Södertälje
Sweden	Familjeläkarna	Stockholm
Sweden	Haga Närakut	Stockholm
Sweden	Karolinska Universitetssjukhuset	Stockholm
Sweden	Sabbatsbergs sjukhus	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Home page of the research group performing the study