Actively Recruiting
Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study of BPL-1357 Vaccine Safety and Efficacy 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental influenza vaccine called BPL-1357 to protect healthy adults aged 18 to 55 against H1N1 influenza infection. This randomized, double-blinded, placebo-controlled phase 2 trial aims to assess the vaccine's safety and its ability to prevent mild-to-moderate influenza disease after a controlled flu virus challenge. The study also explores immune responses and vaccine effects on virus shedding and symptoms. Participants receive two doses of the vaccine or placebo 28 days apart, administered either as a shot in the arm or a nasal spray. The study has two phases: Phase A involves vaccination with five clinic visits over 56 days, including physical exams and sample collections. Phase B consists of a hospital stay of at least nine days, during which participants are intentionally exposed to the flu virus and monitored closely until they test negative for the infection. Throughout the study, participants will undergo blood, urine, and nasal fluid tests, heart function assessments, and complete symptom questionnaires. They will monitor their temperature and record symptoms at home after vaccination. Follow-up visits occur 4 and 8 weeks after hospital discharge to evaluate safety, immune response, and influenza outcomes. The total study duration ranges from 5 to 8 months.
CONDITIONS
Brief Title
BPL-1357 Against H1N1 Influenza Virus Challenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years at the time of consent
- Able to provide written informed consent
- Non-smokers with no current or extensive past use of tobacco, cannabis, vape, or e-cigarette products
- No influenza vaccination within 6 months prior to enrollment and agree not to receive any until study completion
- No other vaccination within 4 weeks prior to enrollment and agree not to receive unlicensed vaccines until study completion
- No prior receipt of broadly protective influenza vaccines
- Participants of childbearing potential must be infertile or agree to use effective contraception through study end
- Able to speak and understand English (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 before enrollment and agree to avoid until study completion
- Agree not to donate blood or blood products during the study
- Not planning to live with high-risk individuals for at least 2 weeks after hospital discharge
- Willing and able to comply with all study procedures
You will not qualify if you...
- Current medical conditions including chronic pulmonary or cardiovascular disease, immunosuppression, malignancy, neurological or neurodevelopmental disorders
- Body mass index less than 18 or greater than 35
- Pregnant or breastfeeding
- History of postinfectious or postvaccine neurological disorders such as Guillain-Barré syndrome
- Stroke within the past 5 years
- Acute illness within 7 days prior to enrollment
- Known allergies to influenza vaccines or treatments
- Allergy to two or more classes of antibiotics
- Receipt of blood products or immunoglobulins within 3 months prior to enrollment
- Receipt of unlicensed drugs or vaccines within specified timeframes prior to enrollment
- History of substance abuse or positive urine drug tests prior to vaccination
- Psychiatric conditions that contraindicate participation
- History of angioedema or anaphylaxis
- Study site staff with direct reporting to the study principal investigator
- Any condition judged by the investigator to increase risk or impair ability to consent
- For Phase B, additional exclusions include positive drug tests prior to virus inoculation, acute illness within 7 days before inoculation, severe clinical abnormalities, pregnancy or breastfeeding, and recent influenza infection
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days between doses
Participants receive two doses of the influenza vaccine or placebo administered intramuscularly or intranasally 28 days apart.
2 visits for vaccination doses
Duration - Up to 17 weeks total from first vaccination
Participants undergo influenza virus challenge and are cared for as inpatients to monitor safety and efficacy outcomes.
Inpatient stay during virus challenge phase
Duration - Up to 15 to 25 weeks from first vaccination
Participants are monitored for safety, influenza symptoms, immune response, and viral shedding after vaccination and challenge.
Multiple visits including assessments at 28 days after second dose and through study completion
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.
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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