Actively Recruiting
BPL-1357 Against H1N1 Influenza Virus Challenge
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-13
129
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. ...
CONDITIONS
Official Title
BPL-1357 Against H1N1 Influenza Virus Challenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years
- Able to provide written informed consent
- Non-smoker and no current use of tobacco, cannabis, vape, or e-cigarettes, nor extensive past use
- No influenza vaccination within 6 months prior to enrollment and agree to avoid flu vaccination until study end
- No other vaccinations within 4 weeks prior to enrollment and agree to avoid unlicensed vaccines until study end
- No prior receipt of broadly protective influenza vaccine
- Participants of childbearing potential must be infertile or agree to use effective contraception and their male partner to use condoms with spermicide
- Able to speak and understand English (and/or Spanish at UTMB site)
- Negative HIV test within 6 months before enrollment
- No use of intranasal, over-the-counter, or herbal medications within 14 days prior to enrollment and agree to avoid them until study end unless approved
- Agree not to donate blood or blood products during study
- Not planning to live with high-risk individuals for at least 2 weeks after hospital discharge
- Willing and able to comply with all trial procedures
You will not qualify if you...
- Current chronic medical conditions including pulmonary disease, cardiovascular disease, diabetes, renal dysfunction, immune deficiency, malignancy, neurological or neurodevelopmental disorders
- Body mass index less than 18 or greater than 35
- Pregnant or breastfeeding
- History of post-infectious or post-vaccine neurological problems such as Guillain-Barré syndrome
- History of stroke within past 5 years
- Acute illness within 7 days before enrollment or before influenza challenge
- Known allergies to influenza vaccines or treatments including oseltamivir and certain antibiotics
- Recent receipt of blood products within 3 months
- Use of unlicensed drugs or investigational agents within 3 months prior to enrollment
- History of alcoholism, drug abuse, or positive drug screen prior to vaccination
- Psychiatric or psychological conditions that contraindicate participation
- History of angioedema or anaphylaxis
- Study site staff reporting directly to the principal investigator
- Any condition deemed by the investigator to increase risk or impair consent ability
- Positive drug screen before influenza virus challenge
- Positive influenza test within 8 weeks before challenge
- Pregnant or breastfeeding at challenge phase
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
University of Texas Medical Branch, Galveston
Galveston, Texas, United States, 77555
Not Yet Recruiting
Research Team
L
Luca T Giurgea, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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