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NCT07215858 · ClinicalTrials.gov registry record · Phase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT07215858: Recruiting Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07215858 is a Phase 2 study that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215858, a Phase 2 study, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics. Objective: To test an experimental flu vaccine. Eligibility: Healthy people aged 18 to 55 years. Design: The study will last 5 to 8 months and has 2 phases, A and B. The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients. Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine. Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row. They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital. ...
Primary Outcome
Safety of the vaccine will be assessed, including standardized measurement of immediate reactogenicity by symptom survey, as well as long-term follow-up for any SAEs, including after challenge, will be performed.
Interventions
- BIOLOGICAL BPL-1357 IM
- BIOLOGICAL BPL-1357 IN
- OTHER Placebo IM
- OTHER Placebo IN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 2 |
What NCT07215858 shows while recruiting
NCT07215858 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which BPL-1357 IM is the first listed.
NCT07215858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07215858 about?
NCT07215858 is a clinical study titled "BPL-1357 Against H1N1 Influenza Virus Challenge". Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics. Objective: T...
What is the current status of trial NCT07215858?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2026-07-15. Estimated completion is 2028-03-01.
What interventions are being tested in trial NCT07215858?
The interventions under investigation include: BPL-1357 IM (BIOLOGICAL), BPL-1357 IN (BIOLOGICAL), Placebo IM (OTHER), Placebo IN (OTHER).
Who is sponsoring clinical trial NCT07215858?
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 NCT07215858's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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