Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BPL-1357 against H1N1 Influenza Virus Challenge
PI - Gregory C. Gray, MD, MPH, University of Texas Medical Branch

Since the start of the 20th century, humanity has experienced five waves of influenza pandemics. The large diversity of influenza viruses in animal reservoirs portends a constant risk of the next inevitable pandemic. Current influenza vaccines are designed to protect against seasonal influenza but leave individuals largely susceptible against heterosubtypic influenza viruses. The development of a new vaccine which can greatly expand the breadth of immunity to future pandemic strains would have the potential to save many lives and decrease global morbidity by a significant amount.

The purpose of this project is to perform a Phase II clinical trial to evaluate the efficacy and safety of the BPL-1357 vaccine in the setting of a healthy volunteer influenza human challenge study. The study will be sponsored and guided by NIAID but performed by UTMB’s research team. The primary hypothesis is that IM (intramuscular) and IN (intranasal) BPL-1357 will be safe and offer protection against mild-moderate influenza disease (MMID) caused by H1N1 influenza challenge compared to placebo.

The primary objectives of this study are to measure the efficacy of BPL-1357, given IM or IN, in preventing MMID compared to placebo; to assess the safety of BPL-1357, given IM or IN in 2 doses 28 days apart, followed by viral challenge with H1N1. The challenge will be with a human 2015 seasonal-like H1N1 strain against which participants are likely to have partial immunity. The study population includes healthy male and female volunteers, ³ 18 to £ 55 years of age. The 120 participants are divided into three study arms (placebo, intranasal vaccine, and intramuscular vaccine).

This [KB1] is a randomized, double-blinded, single-center, phase 2 clinical trial of BPL-1357 administered intranasal or intramuscular in 2 doses 28 days apart compared to a single dose of placebo given intramuscular, followed by viral challenge with H1N1. Participants will be randomized to one of three groups for treatment assignment. This study has two phases: a vaccination phase (Phase A) and a challenge phase (Phase B). On enrollment participants will be randomized 1:1:1 to three groups.

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