Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Changes in the bacterial composition (Bacterial "microbiome") over time
研究概览
简要总结
This study will serve to determine how influenza infection alters the bacterial colonization patterns in the nasal and oropharyngeal compartments, and whether the immune response correlate with these alterations. The investigators will be determining bacterial composition and immune responses in the nose and oropharynx during influenza infection.
Specific Aims
Therefore, the overall aims of this study are as follows:
- To identify baseline composition and kinetic changes in the nasal and oropharyngeal microflora and immune responses after administering intranasal live attenuated influenza virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;
- To identify nasal and oropharyngeal microbial composition and local immune responses during influenza infections and after resolution of infection, and correlate these changes with clinical outcomes.
详细描述
Randomization and Post-Randomization Visits After undergoing the nasal swabs and nasopharyngeal washes, and nasal epithelial brushing, healthy volunteers will be randomly assigned to receive either saline nasal spray (placebo) or FluMist® nasal influenza vaccine (live attenuated influenza vaccine, or LAIV). They will return 1-2 weeks and 4-6 weeks later to repeat the nasal swabs and nasopharyngeal washes, and nasal epithelial brushings done at the Enrollment Visit.
Samples will be processed to isolate 16s bacterial RNA and host RNA. 16s rRNA will be analyzed by 16S sequencing for to determine the composition of the bacterial microbiome pre and post LAIV or saline (placebo) administration. Host immune responses will be assessed based upon microarray analysis of host RNA pre and post LAIV or saline administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •Healthy subjects between the ages of 18 and
- •Approximately half of the subjects will be female and approximately half will be male.
- •Must be eligible to receive live-attenuated nasal version of the influenza vaccine.
- •Must be able to provide signed and dated informed consent.
- •Healthy subjects willing and able to provide oropharyngeal and nasal cavity specimens
排除标准
- •Immunosuppressive conditions or medications
- •chronic systemic medical illness
- •infections or antibiotic use within the past 60 days
结局指标
主要结局
Changes in the bacterial composition (Bacterial "microbiome") over time
时间窗: Changes from baseline at 1-2 weeks and 4-6 weeks after LAIV or saline spray
isolation of 16S RNA from nasal swabs and nasopharyngeal washes for 16S sequencing for bacterial microbiome
Changes in gene expression in the nasal lining of study participants
时间窗: Changes from baseline at 1-2 weeks after LAIV or saline spray
RNA isolation from nasal brushes which will undergo microarray analysis to measure changes in immune gene expression
次要结局
未报告次要终点