Vaccine Efficacy in Diabetic and Elderly Patients
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Louisiana
-
New Orleans、Louisiana、美国、70112
- Tulane Clinical Translational Unit
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:追溯
队列和干预
团体/队列 |
干预/治疗 |
---|---|
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.
|
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
其他名称:
|
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.
其他名称:
|
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.
其他名称:
|
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.
其他名称:
|
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.
其他名称:
|
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.
|
|
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.
|
|
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%).
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in HAI titer from day 0 to day 30 (+/- 4 days)
大体时间:30 days (+/- 4 days)
|
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.
|
30 days (+/- 4 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Inflammatory Soluble Factor and Cellular Analysis
大体时间:day 0
|
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.
|
day 0
|
Inflammatory Soluble Factor and Cellular Analysis additional measurements
大体时间:day 30 (+/- 4 days)
|
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.
|
day 30 (+/- 4 days)
|
合作者和调查者
调查人员
- 首席研究员:Elizabeth B Norton, MPH, PhD、Tulane University School of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Influenza Virus Vaccine的临床试验
-
QIAGEN Gaithersburg, Inc完全的呼吸道合胞病毒感染 | 甲型流感 | 鼻病毒 | 乙型流感 | QIAGEN ResPlex II Advanced Panel | 人类副流感病毒 1 引起的感染 | 副流感 2 型 | 3 型副流感 | 副流感 4 型 | 人类偏肺病毒 A/B | 柯萨奇病毒/埃可病毒 | B/C/E 型腺病毒 | 冠状病毒亚型 229E | 冠状病毒亚型 NL63 | 冠状病毒亚型 OC43 | 冠状病毒亚型 HKU1 | 人类博卡病毒 | Artus 流感 A/B RT-PCR 检测美国
-
Erasme University HospitalRoche Diagnostics; LHUB-ULB终止
-
SENAI CIMATEC招聘中
-
Federal Budgetary Research Institution State Research...完全的
-
Sidney Kimmel Comprehensive Cancer Center at Johns...招聘中