The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Serological outcomes will be compared before and after vaccination and between groups.
研究概览
简要总结
The research of the investigators is focused on the understanding how the immune system functions and responds to intranasal vaccines. Intranasal vaccines do not lead to the same changes in the blood that intramuscular vaccines do. Therefore, the investigators want to look at the function of immune (lymphoid) organs that are near the nose. The closest immune organs are the adenoids and tonsils. Mice do not have tonsils allowing for the investigators to answer these questions. Human lymphoid tissue will allow the investigators to better understand the molecular behavior of these cells in humans.
The purpose of this protocol is to administer the FDA approved live attenuated influenza vaccine or no vaccine to patients undergoing adenoidectomy and/or tonsillectomy for obstructive sleep apnea prior to surgery and then collect the tissue (adenoid and/or tonsil tissue) that would normally be discarded from surgery. This will allow for improved understanding of what happens after vaccination.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea
排除标准
- •Chronic Tonsillitis
- •Immune Deficiency
- •Already received this year's flu vaccine
研究组 & 干预措施
Interventional LAIV
Intranasal Flu Vaccine
干预措施: Live Attenuated Influenza Vaccine (Biological)
No Intervention
No Intervention
结局指标
主要结局
Serological outcomes will be compared before and after vaccination and between groups.
时间窗: From enrollment to 4 weeks after surgery is completed
The comparisons will specifically compare: Mean HAI Ab titers in serum and mucosal secretions
次要结局
- Influenza Specific Antibodies(From enrollment to 4 weeks after surgery)
- Hemagglutinin Levels(From enrollment to 4 weeks after surgery)
- Neuraminidase Levels(From enrollment to 4 weeks after surgery)
- Seroconversion rats(From enrollment to 4 weeks post surgery)
研究者
Adam Kaufman
Assistant Professor of Otolaryngology
University of Maryland, Baltimore