Sponsor study identifier
interventional
33
1 country
1
Study Start
September 11, 2024
Actual (reported)Primary Completion
January 15, 2025
Actual (reported)Study Completion
February 10, 2025
Actual (reported)The overall objective of the present study is to utilize the recombinant H3N2 (A/Texas/71/2017 (H3N2, clade 3C3a)) influenza virus for a controlled human infection model to study host responses to influenza virus with the aim of identifying volatile markers in exhaled breath and expression markers in saliva for early detection of infection after pathogen exposure. This study will aim to recruit up to 40 healthy volunteers between ages 18-45 who will receive a single dose of either intranasally administered placebo (sham inoculum) or the virus challenge strain at a concentration known to elicit a \~60-80% attack rate. The response to influenza challenge will be measured by clinical, laboratory, immunological, digital biomarker, on-breath volatile organic compound data and host RNA expression in both blood and saliva. The study will enroll and challenge up to 34 healthy adult volunteers with live virus plus approximately 6 sham-inoculated controls who will be prescreened for study inclusion to have serological antibody titers of ≤1:40 against the challenge strain. Each participant will complete up to 3 weeks of follow-up post confinement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2024
Actual (reported)June 26, 2024
Actual (reported)September 11, 2024
Actual (reported)January 15, 2025
Actual (reported)February 10, 2025
Actual (reported)Number of participants with detectable viral shedding in nasopharyngeal (NP) swab(s) by qualitative RT-PCR over any 2 days and with symptomatic infection
24 hours post challenge through Day 8
Number of participants with On-breath volatile markers that correlate with clinical symptoms
On-breath volatile markers that correlate with early, pre-symptomatic influenza viral infection, early asymptomatic influenza viral infection, clinical symptoms of infection throughout the confinement period and viral shedding. Captured by the Owlstone Medical Breath Biopsy Collection Station and identified and quantified by thermal-desorption gas chromatography mass spectrometry (TD-GC-MS).
Baseline (Day -1) through Day 8
Number of participants with Biomarker expression changes that correlate with clinical symptoms
Biomarker expression changes in saliva that correlate with early, pre-symptomatic influenza viral infection, early asymptomatic influenza viral infection, clinical symptoms of infection throughout the confinement period and viral shedding. Quantitative RNA expression levels at baseline and post challenge serial timepoints using next-level genomic sequencing (NGS) and RT-qPCR.
Baseline (Day -1) through Day 8
Recombinant H3N2 (A/Texas/71/2017 (H3N2), clade 3C3a) influenza virus at 106 TCID50 dose. This dose has an attack rate of \>70%, and a good safety profile related to adverse events reporting. Each vial of virus stock and diluent will be individually labeled with the product name, description and caution statement.
The viral stock diluent will be used as a sham inoculum, without the viral stock added. Each vial of sham will be labeled with the product name, description and caution statement.
Virus will be administered intranasally
Placebo will be administered intranasally
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke University Medical Center
Durham, North Carolina, 27710, United States
33 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2024
First Posted
June 26, 2024
Study Start
September 11, 2024
Actual (reported)Intradermal Influenza Vaccine in the Young
Contact the study team to confirm eligibility.
Primary Completion
January 15, 2025
Actual (reported)Study Completion
February 10, 2025
Actual (reported)Last Updated
February 26, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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