A Phase 1 interventional study of Influenza A/California/04/09 in Influenza A, sponsored by Duke University. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Duke University · Phase 1, Interventional, and Basic science
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
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 50 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Participants will be inoculated with Influenza A/California/04/09 3.5x10(4) tissue culture infective dose 50% (TCID50) in 1 mL in Dulbecco's phosphate buffered saline (DPBS) delivered by intranasal drops. They will then be monitored as in-patients for 10 days with daily clinical assessment and blood and respiratory tract sampling. Following discharge, they will be followed up for up to 6 months post-inoculation.
Biological: Influenza A/California/04/09
Good Manufacturing Practices-certified Influenza A/California/04/09 3.5x10(4) TCID50 in 1 mL in DPBS delivered by intranasal drops
Viral load
Nasal wash viral load by quantitative polymerase chain reaction (qPCR)
Time frame: 28 days
Symptoms
Self-reported upper and lower respiratory and systemic symptoms by diary card
Time frame: 28 days
Differentially expressed genes in blood
Differentially expressed genes analysed by RNA sequencing of whole blood
Time frame: 9 months
Differentially expressed genes in nasal curettage
Differentially expressed genes analysed by RNA sequencing of nasal curettage samples
Time frame: 9 months
Metabolomics in serum
Differentially expressed metabolites in serum by mass spectrometry
Time frame: 9 months
Plan to share: Yes — Data will be shared with Duke university, such as ethnicity and age. It will be identifiable only by their unique study code, with no personal details.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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