Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics (VAX-002)
Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics
The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine.
In particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination.
There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics.
The investigators hope to enroll 50 subjects at Emory.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30030
- Emory Vaccine Center
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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
描述
Inclusion Criteria:
- Healthy individuals aged 18-40 years.
- Able to understand and give informed consent.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination
Exclusion Criteria:
- You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks.
- You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015.
- You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination.
- You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination.
- You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after
- You had an allergic response or sensitivity to past vaccinations.
- You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.).
- You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension.
- Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity.
- Any history of gastrointestinal disease, kidney or liver diseases.
- Alcohol or drug abuse or psychiatric conditions that in the opinion of the investigator would compromise your participation in this trial.
- Pregnant or are breast feeding.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:IIV Flu Vaccine with Antibiotics
This arm will receive antibiotics prior and after IIV administration.
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This is an FDA approved and tested Inactivated Flu Vaccine.
其他名称:
This is a standard antibiotic
其他名称:
This is a standard antibiotic.
This is a standard antibiotic.
其他名称:
|
|
有源比较器:IIV Flu Vaccine
This arm will not take antibiotics in conjunction with IIV.
|
This is an FDA approved and tested Inactivated Flu Vaccine.
其他名称:
|
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 |
|---|---|---|
|
Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
大体时间:At day 30
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Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
|
At day 30
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合作者和调查者
出版物和有用的链接
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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