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NCT06476275 · ClinicalTrials.gov registry record · Phase 1
Single Dose Texas 2017 (H3N2) Challenge Study
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT06476275 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 33 participants.
The verdict
NCT06476275, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL Influenza A/Texas/71/2017 (H3N2)
- BIOLOGICAL Sham placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2024-09-11 |
| Est. Completion | 2025-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06476275
The ClinicalTrials.gov registry entry for NCT06476275 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Influenza A/Texas/71/2017 (H3N2) is the first listed.
NCT06476275 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06476275 about?
NCT06476275 is a clinical study titled "Single Dose Texas 2017 (H3N2) Challenge Study". 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 i...
What is the current status of trial NCT06476275?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2024-09-11. Estimated completion is 2025-02-10.
What interventions are being tested in trial NCT06476275?
The interventions under investigation include: Influenza A/Texas/71/2017 (H3N2) (BIOLOGICAL), Sham placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT06476275?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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