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NCT04044352 · ClinicalTrials.gov registry record · Phase 1
H1N1v Virus Challenge Study in Healthy Subjects
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT04044352: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04044352 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044352, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
This is a study of a reverse-engineered, Good Manufacturing Practice (GMP) grade, antiviral-sensitive, influenza A/Bethesda/MM2/H1N1 virus (A/California/04/2009/H1N1-like) infection to assess the effect of pre-existing immunity on clinical and immunological responses. Up to 80 healthy adult subjects will undergo intranasal inoculation with A/Bethesda/MM2/H1N1 virus, and their clinical manifestations, viral shedding and immunological responses will be characterized. The Primary Objective for this study is to evaluate the association of symptomatic Reverse Transcription-Polymerase Chain Reaction (RT-PCR)-positive influenza virus infection post-challenge and pre-existing Hemagglutinin Inhibition Test (HAI) antibody titers.
Primary Outcome
Blood samples were collected pre-challenge (Day -2) for the HAI assay conducted with the A/Bethesda/MM2/H1N1 virus as the antigen. The geometric mean of each sample's replicate results was calculated from available results, then grouped by seroprotection status (titer results \>= 1:40 vs \< 1:40). MMID is a composite endpoint determined by the presence of viral shedding (detected by any approved positive RT-PCR test from a NP swab), accompanied by at least one the following symptoms occurring an
Interventions
- BIOLOGICAL Influenza A/Bethesda/MM2/H1N1 Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2020-03-02 |
| Phase | Phase 1 |
What the finished NCT04044352 record still lists
NCT04044352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 1 intervention - of which Influenza A/Bethesda/MM2/H1N1 Challenge is the first listed.
NCT04044352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04044352 about?
NCT04044352 is a clinical study titled "H1N1v Virus Challenge Study in Healthy Subjects". This is a study of a reverse-engineered, Good Manufacturing Practice (GMP) grade, antiviral-sensitive, influenza A/Bethesda/MM2/H1N1 virus (A/California/04/2009/H1N1-like) infection to assess the effect of pre-existing immunity on clinical and immunological responses. Up to 80 healthy adult subjects...
What is the current status of trial NCT04044352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2019-10-22. Estimated completion is 2020-03-02.
What interventions are being tested in trial NCT04044352?
The interventions under investigation include: Influenza A/Bethesda/MM2/H1N1 Challenge (BIOLOGICAL).
Who is sponsoring clinical trial NCT04044352?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04044352's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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