Protection From Influenza: Determining the Impact of Prior Infection
Studienübersicht
Detaillierte Beschreibung
Significance: This study will provide critical information on the best technique in vaccine candidate testing and improve influenza treatment approaches. The long-term goal of this research is to identify the T-cell responses that are surrogates (biomarkers) of serious complications of influenza in older adults and predict vaccine efficacy (prevention of influenza illness) and vaccine effectiveness (prevention of serious complications). Further, translating new insights into age-related immune dysfunction to the design of new influenza vaccines is critical to addressing this unmet need in the population aged 65 and older.
Innovation: The study will help in the validation of clinical tools and biomarkers as prognostic indicators of influenza illness severity in vaccinated older adults, point-of-care diagnostics that would direct other preventive strategies to reduce the impact of influenza illness in vaccinated older adults, and correlates of protection to evaluate the potential of new influenza vaccines to enhance protection against the serious complications of influenza illness. The investigators have established that GrzB activity and the IFNg: IL-10 ratio in influenza-stimulated PBMC correlate with protection against influenza, and preliminary data to show that low GrzB activity in influenza-stimulated PBMC correlates with more severe disease and higher levels of frailty. The innovations of this project are the established methods for developing correlates of protection, the clinical insights into how frailty affects immune-mediated protection against influenza, and the direct translation of this research to provide a reasonable method for primary care clinicians to estimate vaccine effectiveness in an individual older person. These results will translate to the practical design of clinical trials to evaluate the potential for new influenza vaccines to better protect against the serious complications of influenza and complement those based on antibody titers and/or clinical outcomes alone.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Amanda Axler, BSc.
- Telefonnummer: 1924 7055237300
- E-Mail: aaxler@hsnri.ca
Studienorte
-
-
Ontario
-
Sudbury, Ontario, Kanada, P3E 5J1
- Rekrutierung
- Health Sciences North Research Institute
-
Kontakt:
- Amanda l Axler, BSc
- Telefonnummer: 1924 705-523-7300
- E-Mail: aaxler@amric.ca
-
Kontakt:
- Beth Gentleman, BSc
- Telefonnummer: 2631 705-523-7300
- E-Mail: bgentleman@amric.ca
-
Hauptermittler:
- Janet E McElhaney, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Written informed consent provided by the participant.
Age 65 years of age or older admitted to Health Sciences North with at least one the following:
- Laboratory confirmed influenza illness
- Acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
- Any respiratory or influenza-like symptoms (dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness) that a test for influenza was negative.
- Willing to receive influenza vaccination in the subsequent flu season
Exclusion Criteria:
- Patients whose reason for hospital admission was unrelated to influenza or (for example patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory).
- Chest x-ray positive for pneumonia.
- Study participants who cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination.
- Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Case
older adult patients (over the age of 65) admitted to Health Sciences North with laboratory confirmed influenza illness (LCII)
|
|
|
Control
matched control subjects (non-LCII)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
High expression of CTL associated cytokines and granzymes in PBMC's are predictors of influenza infection severity.
Zeitfenster: 2 years
|
PBMCs from adults hospitalized for laboratory confirmed influenza illness (LCII) will be collected at admission and 30 days post hospitalization.
These samples will be matched with hospitalized non-LCII adult controls.
T-cells will be isolated from whole blood samples and gene expression of IFNg, IL10 and GrzB will be measured and compared between time points and subjects.
These levels do not have a separate unit of measure.
|
2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Vaccination in previously infected individuals increases the protection provided by subsequent vaccination and will be higher than those receiving vaccination alone (with no previous infection)
Zeitfenster: 2 years
|
Older adults hospitalized for influenza illness the previous season will be compared to matched, hospitalized older adults with influenza-like illness (non-LCII).
PBMCs will be collected from each group, before receiving influenza vaccination and 4 weeks after vaccination.
PBMCs will be challenged ex vivo with influenza virus and gene expression of CTL related genes will be measured and compared between each group.
|
2 years
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Protection from Influenza
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Flu Vaccine
-
University of California, San FranciscoAmerican Cancer Society, Inc.; Kaiser PermanenteAbgeschlossen
-
Green Cross CorporationAbgeschlossen
-
GlaxoSmithKlineAbgeschlossen
-
Tatyana ZubkovaAbgeschlossenRespiratory-Syncytial-Virus-InfektionenRussische Föderation
-
Maisonneuve-Rosemont HospitalRekrutierung
-
Eurocine Vaccines ABAbgeschlossen
-
GlaxoSmithKlineAktiv, nicht rekrutierend
-
DiaSorin Molecular LLCNoch keine RekrutierungCoronavirus Krankheit 2019 | Grippe A | Grippe Typ BAustralien
-
Medigen Vaccine Biologics Corp.Abgeschlossen
-
Shanghai Jiao Tong University School of MedicineRekrutierung