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- Klinische proef NCT02675608
Vaccine Efficacy in Diabetic and Elderly Patients
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane Clinical Translational Unit
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Year 1 Inclusion Criteria:
- Group 1: Must be 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
- Group 2: Must be ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
- Group 3: Must be between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
- Group 4: Must be ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
- Group 5: Must be between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.
Year 1 Exclusion Criteria:
- a history of sensitivity to any of the vaccine components or to influenza vaccine
- a history of Guillain-Barré syndrome
- a history of known or suspected impairment of immunologic function outside of criteria described in the inclusion criteria, including clinically significant liver disease, arthritis, moderate to severe renal (kidney) disease, and ongoing infections
- a history of a bleeding disorder or received anticoagulants within the last 3 weeks
- received the influenza vaccine in the past 6 months or any other vaccines within the last 3 months
- received immunosuppressive therapy within the last 6 months
- received long-term systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months
- received blood or blood-derived products within the last 3 months
- a daily aspirin intake of >81mg
- a blood pressure >150/95 at screening
Year 2 Inclusion Criteria:
Group 1: They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
Group 2: They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
Group 3: If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
NOTE: Current diabetes is defined by patient report of physician diagnosis. Subjects with a history of diabetes which has resolved and no longer requires therapy are not considered to have current diabetes, e.g, women with a history of gestational diabetes, steroid-induced or medication-induced.
Group 4: If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
Year 2 Subjects will be excluded if they have any of the following:
- a history of known or suspected impairment of immunologic function, including clinically significant liver disease, arthritis, moderate to severe renal (kidney) disease, HIV, and ongoing infections
- a history of a bleeding disorder or received anticoagulants within the last 3 weeks
- a history of heart failure
- a history of receiving immunosuppressive therapy within the last 6 months
- a history of receiving long-term systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months
- a history of receiving blood or blood-derived products within the last 3 months
- a daily aspirin intake of >325mg
- are pregnant
There are no inclusion/exclusion criteria based on race. Each group will have a targeted enrollment of 50% female to male ratio. Women cannot be pregnant or breastfeeding. There will be no children involved in this study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Retrospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Year 1 Group 1
They are between 18-65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Andere namen:
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Year 1 Group 2
They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Andere namen:
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Year 1 Group 3
They are between 18-65 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Andere namen:
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Year 1 Group 4
They are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Andere namen:
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Year 1 Group 5
They are between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Andere namen:
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Year 2 Group 1
They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
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Year 2 Group 2
They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
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Year 2 Group 3
If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
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Year 2 Group 4
If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in HAI titer from day 0 to day 30 (+/- 4 days)
Tijdsspanne: 30 days (+/- 4 days)
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Blood samples collected days 0 and 30 will be evaluated and compared for flu antibodies using the standards HAI assay with individual virus strains contained in vaccine.
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30 days (+/- 4 days)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Inflammatory Soluble Factor and Cellular Analysis
Tijdsspanne: day 0
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Inflammatory Analysis will be performed on day 0 samples.
Soluble factors in the serum will be analyzed using flow cytometry and bioplex.
This analysis will evaluate cellular proliferation, senescence, and recognized inflammatory subsets within myeloid and lymphoid cell subsets.
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day 0
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Inflammatory Soluble Factor and Cellular Analysis additional measurements
Tijdsspanne: day 30 (+/- 4 days)
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Additional Inflammatory Analysis will be performed on day 30 samples.
Soluble factors in the serum will be analyzed using flow cytometry and bioplex.
This analysis will evaluate cellular proliferation, senescence, and recognized inflammatory subsets within myeloid and lymphoid cell subsets.
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day 30 (+/- 4 days)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elizabeth B Norton, MPH, PhD, Tulane University School of Medicine
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15-727936
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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