Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- markers of inflammation
研究概览
简要总结
The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ages 18-49 years old,
- •not yet received influenza vaccine for 2019-2020, and
- •capable of giving signed informed consent.
排除标准
- •Immunocompromising condition (e.g. HIV/AIDS, chemotherapy, immune suppressing medications),
- •active smoking within past 6 months,
- •asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure,
- •pregnancy,
- •current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids),
- •prior adverse reaction to influenza vaccine,
- •history of Guillain-Barre syndrome,
- •egg allergy,
- •close contact with an individual with severe immunodeficiency/immunosuppression.
研究组 & 干预措施
open label
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
干预措施: Flumist Quadrivalent Nasal Product (Drug)
结局指标
主要结局
markers of inflammation
时间窗: change in inflammatory cytokines from baseline to day 2
a standard panel of inflammatory cytokines (Luminex Performance Human XL Cytokine Discovery Panel assay, R\&D Systems; results reported in pg/ml) will be measured in samples obtained from nasal washing and nasal oropharyngeal swabs
influenza virus replication
时间窗: day 2
virus replication will be measured using RT-PCR and reported as genomic units, from samples obtained from nasal washing and nasal oropharyngeal swabs
cystic fibrosis transmembrane conductance regulator function
时间窗: change in NPD from baseline to day 2
nasal potential difference (NPD) measurement
次要结局
未报告次要终点
研究者
David Lafon
Assistant Professor
University of Alabama at Birmingham