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NCT07063849 · ClinicalTrials.gov registry record · Phase 1
Pilot Influenza Challenge Study
A Phase 1 study of Influenza, sponsored by Daniel Hoft, MD, PhD.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07063849 is a Phase 1 study of Influenza that is active but no longer recruiting, run by Daniel Hoft, MD, PhD. The registered enrollment target is 12 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07063849, a Phase 1 study of Influenza, is active but no longer recruiting, sponsored by Daniel Hoft, MD, PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a research study to understand what happens when a person is infected with influenza ("flu") and how the body controls the infection. Healthy participants (challenge) will be infected with a strain of flu (H3N2), and followed to see what symptoms occur and when they occur. Blood will be drawn and nasopharyngeal (NP) swabs will be collected before participants are infected to understand if having antibodies can protect participants from flu infection or lead to a milder flu illness. Blood will also be drawn and NP swabs collected after participants are infected to understand how and when the body's immune response to flu occurs. Participants will also breathe through a device for virus collection every other day. Participants will be screened during one or more visits and will stay in the inpatient challenge unit for at least 10 days, maybe longer. Participants will complete a FLU PRO Diary Card daily. Blood will be drawn before the challenge and on Days 2, 4, and 8 while in the inpatient unit. NP samples will be taken every day to check for viruses and on certain days, immune responses such as antibodies. If on Day 8 (7 days after the challenge) the participant still has flu virus, medicine will be offered to treat the flu and the participant will be asked to stay in the challenge unit until NP swabs are negative for 2 consecutive days. Once the participant is discharged from the challenge unit, they will be asked to return to the clinic for 3 more visits. At the end of the study will be a final phone call.
Conditions Studied
Interventions
- BIOLOGICAL A/Texas
Study Locations (1)
Missouri
- Saint Louis University Center for Vaccine Development - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-05-20 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07063849
The ClinicalTrials.gov registry entry for NCT07063849 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is Daniel Hoft, MD, PhD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which A/Texas is the first listed.
NCT07063849 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT07063849 about?
NCT07063849 is a clinical study titled "Pilot Influenza Challenge Study". This is a research study to understand what happens when a person is infected with influenza ("flu") and how the body controls the infection. Healthy participants (challenge) will be infected with a strain of flu (H3N2), and followed to see what symptoms occur and when they occur. Blood will be draw...
What is the current status of trial NCT07063849?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-05-20. Estimated completion is 2026-06-30.
What conditions does trial NCT07063849 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT07063849?
The interventions under investigation include: A/Texas (BIOLOGICAL).
Who is sponsoring clinical trial NCT07063849?
This trial is sponsored by Daniel Hoft, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07063849 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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