BPL-1357 Against H1N1 Influenza Virus Challenge

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07215858
Phase
PHASE2
Status
Recruiting
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Conditions

  • Human
  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BPL-1357 IM — BIOLOGICAL
    Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intramuscularly.
  • BPL-1357 IN — BIOLOGICAL
    Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intranasally.
  • Placebo IM — OTHER
    Placebo given intramuscularly.
  • Placebo IN — OTHER
    Placebo given intranasally.

Study Details

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. ...

Key Dates

Start date
Jun 23, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
129 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group A
    BPL-1357 given intramuscularly. Placebo given intranasally.
  • Experimental: Group B
    BPL-1357 given intranasally. Placebo given intramuscularly.
  • Placebo Comparator: Group C
    Placebo given intramuscularly and intranasally.

Primary Outcome Measure

Safety (solicited AEs 7 days after vaccination, unsolicited adverse events (AEs) within 28 days post-vaccination, serious AEs (SAEs) [ Time Frame: 15-25 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222
University of Texas Medical Branch, GalvestonGalvestonTexas77555
Gregory Gray
[email protected]
409-772-0633

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MDUniversity of Texas Medical Branch, Galveston· Galveston, TX

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