NCT03207152Unknown1 期
Biomarkers Predicting Infectivity in an Experimental Human Influenza Model
Duke University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Viral load
研究概览
简要总结
This study aims to test the hypothesis that gene transcriptional changes occur within 24 hours of virus exposure in the blood and nasal mucosa, and to identify early biomarker signatures that are predictive of higher viral shedding at the peak of disease
详细描述
This study will systematically investigate the early pre-symptomatic period following exposure to influenza in humans. The data obtained will be essential for further understanding of the natural history of human antiviral responses, and will allow us to identify a panel of biomarkers that can predict which individuals will go on to more severe symptoms and higher viral shedding, so that treatments and other interventions can be made at an early stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy persons aged 18 to 55 years, able to give informed consent
排除标准
- •Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood
- •Inhaled bronchodilator or steroid use within the last 12 months
- •Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 6 months
- •Acute upper respiratory infection or sinusitis in the past 6 weeks
- •Smoking in the past 6 months OR >5 pack-year lifetime history
- •Subjects with allergic symptoms present at baseline
- •Clinically relevant abnormality on chest X-ray
- •Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (>65 years), immunosuppressed persons, or those with chronic respiratory disease
- •Subjects with known or suspected immune deficiency
- •Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
- •Known immunoglobulin A deficiency, immotile cilia syndrome, or Kartagener's syndrome
- •History of frequent nose bleeds
- •Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
- •Pregnant or breastfeeding women
- •Positive urine drug screen
- •Detectable baseline haemagglutination inhibition titres against influenza challenge strains
- •History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine, or with life-threatening reactions to previous influenza vaccinations
- •All women of childbearing age will have a pregnancy test performed prior to virus inoculation to exclude pregnancy and be required to use contraception throughout the study.
结局指标
主要结局
Viral load
时间窗: 28 days
Nasal wash viral load by quantitative polymerase chain reaction (qPCR)
次要结局
- Symptoms(28 days)
- Metabolomics in serum(9 months)
- Differentially expressed genes in blood(9 months)
- Differentially expressed genes in nasal curettage(9 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Markers for Early Detection of Prostate CancerProstate CancerNCT00340717National Cancer Institute (NCI)100
招募中
不适用
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma VirusSquamous Cell Carcinoma of the OropharynxCarcinomas of Unknown Primary SiteHigh-risk Human Papillomavirus InfectionLiquid BiopsyLymph Node MetastasisOccult Tumor of the Head and Neck AreaNCT05918510Regina Elena Cancer Institute142
已完成
不适用
The Application of Transcriptomics in the Treatment of Ulcerative Colitis With UstekinumabUlcerative ColitisNCT05896943Evangelismos Hospital38
已完成
不适用
DNA Array Analysis of Patients With Cervical CancerCervical CancerNCT00512551M.D. Anderson Cancer Center18
招募中
不适用
Biomarkers in InfectionSepsisInfectionInflammationNCT02545478Beth Israel Deaconess Medical Center4,200