Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06401720
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cryopreserved PBMCs. Plasma. Serum. Nasopharyngeal aspirate liquid. Endotracheal tube aspirate liquid. Nasal swab liquid. Nasopharyngeal swab liquid. Nasal curette liquid. Breath Explor devices.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-04', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of immune cells', 'timeFrame': '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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza A virus (IAV)', 'Influenza B virus (IBV)', 'SARS CoV 2', 'respiratory syncytial virus (RSV)', 'immunology', 'age-related differences'], 'conditions': ['Influenza A Infection', 'Influenza B Virus Infection', 'SARS CoV 2 Infection', 'RSV Infection']}, 'referencesModule': {'references': [{'pmid': '37061513', 'type': 'BACKGROUND', '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.'}, {'pmid': '36752598', 'type': 'BACKGROUND', '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.'}, {'pmid': '34665783', 'type': 'BACKGROUND', 'citation': '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': '33492309', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://ki.se/en/research/groups/respiratory-and-systemic-immune-responses-in-human-pulmonary-viral-infection-and#tab-start', 'label': 'Home page of the research group performing the study'}]}, 'descriptionModule': {'briefSummary': '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:\n\nWhy 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?\n\nParticipants 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:\n\n* Blood sample by venepuncture\n* Blood sample by capillary sampling\n* Nasopharyngeal aspirate\n* Nasopharyngeal swab\n* Endotracheal tube aspirate\n* Nasal swab\n* Nasal curette\n* Breath Explor (sampling of expired air)\n\nResearchers will compare obtained results with the same type of samples from healthy controls.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are from primary care clinics, hospitalized, or household contacts of subjects seeking health care at a primary care clinic.\n\nThe study population is included in the greater Stockholm area within the Region Stockholm health care region.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Patients:\n\n* Influenza A like symptoms and/or\n* Confirmed airway infection\n\nExclusion Criteria Patients:\n\n* Current malignancies\n* Immunosuppressive treatment, not including/except hydrocortisone\n\nExclusion Criteria Controls:\n\n* Airway infection within the past four weeks\n* Ongoing antibiotic treatment\n* Immunosuppressive treatment'}, 'identificationModule': {'nctId': 'NCT06401720', 'acronym': 'NPA-DC', 'briefTitle': 'Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Respiratory Immune Responses in Human Influenza Virus Infection Across Age to Understand What Dictates Disease Severity', 'orgStudyIdInfo': {'id': '2023-01776'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with airway infection. Enrolled while seeking health care or when hospitalized.'}, {'label': 'Controls', 'description': 'Subjects without airway infection.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Södertälje', 'country': 'Sweden', 'facility': 'Södertälje Sjukhus', 'geoPoint': {'lat': 59.19554, 'lon': 17.62525}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Familjeläkarna', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Haga Närakut', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Sabbatsbergs sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Anna Smed Sörensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anna Smed Sörensen', 'investigatorAffiliation': 'Karolinska Institutet'}}}}