BPL-1357 Against H1N1 Influenza Virus Challenge
Eligible age
18–55 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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. ...
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
You may not qualify if…
- ✕ Individuals meeting any of the following criteria will be excluded from study participation:
- ✕ 1. Current medical conditions (self-reported or medically documented) including but not limited to:
- ✕ 1. Chronic pulmonary disease (e.g., asthma, emphysema).
- ✕ 2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- ✕ 3. Chronic medical conditions requiring close medical follow-up or hospitalization (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- ✕ 4. Immunosuppression, immune deficiency, or ongoing malignancy.
- ✕ 5. Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures).
- ✕ 2. Body mass index (BMI) \<18 and \>35.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07215858 · last updated 2026-09-25