Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
研究概览
简要总结
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.
详细描述
We will study using a system biology approach the immune responses to IIV alone vs. IIV with antibiotic administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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-
- •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.
研究组 & 干预措施
IIV Flu Vaccine with Antibiotics
This arm will receive antibiotics prior and after IIV administration.
干预措施: IIV Flu Vaccine (Drug)
IIV Flu Vaccine with Antibiotics
This arm will receive antibiotics prior and after IIV administration.
干预措施: Metronidazole (Drug)
IIV Flu Vaccine with Antibiotics
This arm will receive antibiotics prior and after IIV administration.
干预措施: Neomycin (Drug)
IIV Flu Vaccine with Antibiotics
This arm will receive antibiotics prior and after IIV administration.
干预措施: Vancomycin (Drug)
IIV Flu Vaccine
This arm will not take antibiotics in conjunction with IIV.
干预措施: IIV Flu Vaccine (Drug)
结局指标
主要结局
Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
时间窗: At day 30
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
次要结局
未报告次要终点
研究者
Nadine Rouphael
Assistant Professor
Emory University