- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02675608
Vaccine Efficacy in Diabetic and Elderly Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Clinical Translational Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
Other Names:
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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.
|
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Other Names:
|
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%).
|
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Other Names:
|
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%).
|
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Other Names:
|
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.
|
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Other Names:
|
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%).
|
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HAI titer from day 0 to day 30 (+/- 4 days)
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory Soluble Factor and Cellular Analysis
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth B Norton, MPH, PhD, Tulane University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-727936
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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