Influenza A InfectionNPA-DCNCT06401720
Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection
An observational study of Influenza A Infection and Influenza B Virus Infection, run by Karolinska Institutet at 5 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza A Infection, Influenza B Virus Infection, SARS CoV 2 Infection
- How many people
- 800 participants
- Where
- 5 sitesSweden
- Study dates
- 1 Jan 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Influenza A like symptoms and/or
- Confirmed airway infection
Who cannot join
- Current malignancies
- Immunosuppressive treatment, not including/except hydrocortisone
- Airway infection within the past four weeks
- Ongoing antibiotic treatment
- Immunosuppressive treatment
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites
Södertälje Sjukhus
Södertälje
Familjeläkarna
Stockholm
Haga Närakut
Stockholm
Karolinska Universitetssjukhuset
Stockholm
Sabbatsbergs sjukhus
Stockholm
About this study
Official title: Respiratory Immune Responses in Human Influenza Virus Infection Across Age to Understand What Dictates Disease Severity
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?
Read more
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.
Read the 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.
- Keywords
- Influenza A virus (IAV), Influenza B virus (IBV), SARS CoV 2, respiratory syncytial virus (RSV), immunology, age-related differences
- Medical subject headings
- COVID-19, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with airway infection. Enrolled while seeking health care or when hospitalized. | |
| Controls | Subjects without airway infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Influenza A InfectionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Smed Sörensen, Karolinska Institutet
- Investigators
- Anna Smed Sörensen, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401720
- Sponsor's protocol ID
- 2023-01776
- Other IDs
- 2023
- Acronym
- NPA-DC
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 helper cells correlates with severe COVID-19. Nat Commun. 2023 Apr 15;14(1):2164. doi: 10.1038/s41467-023-37835-9.
PubMed 37061513Vangeti 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.
PubMed 36752598Cagigi 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.
PubMed 34665783Falck-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.
PubMed 33492309
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Immune Responses in Human Influenza Virus Infection Across Age to Understand What Dictates Disease Severity
- ClinicalTrials.gov ID
- NCT06401720
- Acronym / sponsor ID
- NPA-DC / 2023-01776
- Keywords
- Influenza A virus (IAV), Influenza B virus (IBV), SARS CoV 2, respiratory syncytial virus (RSV), immunology, age-related differences
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with airway infection. Enrolled while seeking health care or when hospitalized. |
| Controls | – | –Subjects without airway infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Influenza A like symptoms and/or
- Confirmed airway infection
Key exclusion criteria (5 listed)
- Current malignancies
- Immunosuppressive treatment, not including/except hydrocortisone
- Airway infection within the past four weeks
- Ongoing antibiotic treatment
- Immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 37061513Yu 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.
- Background: PubMed 36752598Vangeti 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.
- Background: PubMed 34665783Cagigi 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.
- Background: PubMed 33492309Falck-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.
- Home page of the research group performing the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Smed Sörensen, PhD principal investigator
Karolinska Institutet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza A Infection and Influenza B Virus Infection, run by Karolinska Institutet at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401720, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.