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Study of BPL-1357 Vaccine for H1N1 Flu

This study is testing an experimental flu vaccine called BPL-1357 to see if it can protect against H1N1 influenza (flu) and if it is safe. Researchers are looking for healthy people aged 18 to 55 years old who do not smoke or use vape products. You would receive BPL-1357 either as a shot in the arm or as a nasal spray, or you might receive a placebo (an inactive substance). The main goals are to see how well BPL-1357 prevents mild-to-moderate flu disease and to check for any side effects. The study aims to enroll 129 participants.

Study design
This is a randomized, double-blinded, placebo-controlled study with 129 participants. It has two phases: a vaccination phase and a challenge phase where participants are exposed to the H1N1 flu virus.
What's involved
The study will last 5 to 8 months and involves two doses of the vaccine or placebo given 28 days apart. Participants will undergo an influenza challenge as inpatients.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for 7 days after vaccination for solicited adverse events, 28 days for unsolicited adverse events, and serious adverse events will be measured at 15-25 weeks. The rate of mild-to-moderate influenza disease will be measured at 7-17 weeks.

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NCT07215858

BPL-1357 Against H1N1 Influenza Virus Challenge

Recruiting
PHASE2Ages 18–55InterventionalPrevention
National Institute of Allergy and Infectious Diseases (NIAID)
~129 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:BPL-1357 IMBPL-1357 INPlacebo IMPlacebo IN

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety (solicited AEs 7 days after vaccination, unsolicited adverse events (AEs) within 28 days post-vaccination, serious AEs (SAEs)
Measured over 15-25 weeks
+1 more outcome measured

Conditions

Influenza
Human

Explore related trials

Influenza

Where it's being run

2 sites across 2 states
Maryland1
Texas1

Study leadership

  • Luca T Giurgea, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Luca T Giurgea, M.D.
[email protected]
(301) 538-5235
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Bilateral tubal ligation
Implant of levonorgestrel
Injectable progestogen
Oral contraceptive pills
Diaphragm with spermicide
Intrauterine device (IUD)
Sexual abstinence
Vasectomized partner 8. Able to speak and understand English. 9. A negative HIV test within 6 months before enrollment. 10. Has not used IN medications (including but not limited to nasal sprays, sinus rinses), and has not routinely used over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John's Wort) within 14 days (about 2 weeks) prior to study enrollment and agrees not to use these medications until after the end of study participation (PBD63), unless approved by the investigator. 11. Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63). 12. Not planning on cohabitating with any high-risk individuals (e.g., infants, elderly, those with high-risk conditions (e.g., pregnancy, medical conditions such as those outlined in exclusion criterion 1) for at least 2 weeks after discharge from the inpatient portion of this study. 13. Participant is willing and able to comply with all trial procedures.

What this trial measures

  • Safety (solicited AEs 7 days after vaccination, unsolicited adverse events (AEs) within 28 days post-vaccination, serious AEs (SAEs)15-25 weeks

    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.

  • Rate of mild-to-moderate influenza disease (MMID), defined as a positive US FDA-approved clinical test for influenza plus one or more influenza symptoms7-17 weeks

    Rate of MMID will be compared across groups to estimate vaccine efficacy.