BPL-1357 for Flu

This trial explores a new flu vaccine called BPL-1357. Researchers aim to determine if it offers better protection against flu viruses, particularly those with pandemic potential. Participants will receive a combination of the vaccine and placebo as a shot, nasal spray, or both, and then be exposed to a flu virus to assess the vaccine's effectiveness. Healthy non-smokers who haven't recently received a flu shot and are willing to stay in the hospital for a few days might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you stop using nasal sprays, sinus rinses, over-the-counter medications like aspirin and antihistamines, and herbal medications for at least 14 days before joining and until the end of the study, unless approved by the investigator.

Research shows that BPL-1357, the experimental flu vaccine under investigation, is being studied for safety. BPL-1357 contains four types of inactivated (non-live) bird flu viruses, which cannot cause infection. Previous studies have examined both the injection (into the muscle) and nasal spray (into the nose) versions of this vaccine.

These studies have focused on ensuring the vaccine's safety and its ability to trigger an immune response, which helps the body fight infections. Both the injection and nasal spray forms of BPL-1357 are being tested for tolerability. Researchers are monitoring for any harmful side effects and their frequency.

Most flu treatments, like antivirals such as oseltamivir, are taken orally and focus on reducing symptoms and virus replication. BPL-1357 is unique because it explores different delivery methods—one version is administered intramuscularly and another intranasally, which could offer more flexibility and effectiveness in different patient scenarios. Researchers are excited about BPL-1357 because the intranasal delivery might stimulate a stronger local immune response directly in the respiratory tract, potentially enhancing protection against the flu. Additionally, using a combination of intramuscular and intranasal administration could provide comprehensive immune coverage, making it a promising alternative to current flu treatments.

Research has shown that BPL-1357 has promising results in early studies against the flu. Tests in mice and ferrets demonstrated strong protection against various types of the influenza A virus. In one study, animals that received BPL-1357 survived after exposure to deadly doses of six different flu strains. Although these results are encouraging, human trials are necessary to confirm its effectiveness in people. In this trial, participants in Group A will receive BPL-1357 as a shot in the arm, while those in Group B will receive it as a nasal spray, offering flexible delivery options. Group C will receive a placebo both intramuscularly and intranasally.³⁶⁷⁸⁹