Phase 2 Study of BPL-1357 Vaccine Given by Shot or Nasal Spray to Protect Adults Against H1N1 Influenza Infection

What this Trial Is About

Influenza is a serious global health threat causing millions of infections and hundreds of thousands of deaths annually. Current vaccines protect against seasonal flu, but broader vaccines are needed to defend against potential flu pandemics. This phase 2 clinical trial evaluates the safety and effectiveness of an experimental flu vaccine called BPL-1357, given either as a shot or nasal spray, to protect healthy adults aged 18 to 55 years from H1N1 influenza infection. Participants are randomly assigned to one of three groups one receiving the vaccine as an injection plus a nasal placebo, another receiving the vaccine as a nasal spray plus an injection placebo, and a third group receiving placebos for both. The study has two phases Phase A includes two doses of vaccine or placebo 28 days apart with five clinic visits over 56 days for vaccinations and sample collections. Phase B involves hospital admission for at least nine days where participants are intentionally exposed to the flu virus and closely monitored until they test negative for the flu. During the study, participants undergo physical exams, blood, urine, and nasal secretion tests, heart function evaluations, and report symptoms and temperature changes. Follow-up visits occur 4 and 8 weeks after hospital discharge to track safety, immune response, flu symptoms, and viral shedding duration. The study measures vaccine safety, flu disease occurrence, immune responses, and other clinical and laboratory outcomes over 5 to 8 months of participation.

BPL-1357 Against H1N1 Influenza Virus Challenge