HilleVax, Inc. (NASDAQ:HLVX), a biopharmaceutical company focused on the development and commercialization of novel vaccine candidates, reported today dosing of the first subjects in its previously announced Phase 2b clinical trial of HIL-214, the company's virus-like particle (VLP) based vaccine candidate, for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection in infants.
"We're pleased to have dosed the first subjects in this Phase 2b study, the first ever field efficacy clinical trial of a norovirus vaccine candidate in infants," said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. "We believe HIL-214 has the potential to address a vast unmet need which includes approximately 700 million cases, 200,000 deaths, and $60 billion of economic burden from norovirus-related AGE worldwide each year."
The clinical trial is a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants of approximately 5 months of age at time of initial vaccination at sites in the United States and Latin America. The study is planned to enroll 3,000 subjects who will be randomized 1:1 to receive a two-dose regimen of either HIL-214 or placebo. The primary objective of the trial is to evaluate the protective efficacy of HIL-214 against the first confirmed moderate or severe AGE event due to GI.1 or GII.4 norovirus strains (excluding certain co-infections) that occurs prior to each subject reaching 12 months of age. A key secondary endpoint is to evaluate the protective efficacy of HIL-214 against any GI or GII norovirus strain. A pre-specified safety and immunogenicity analysis is planned for the first 200 subjects.