HilleVax, Inc. reported that an independent safety data monitoring committee (DMC) completed a prespecified review of safety data from the 203 subjects enrolled in the run-in portion of NEST-IN1 (Norovirus Efficacy and Safety Trial for INfants, or NOR-212), the company's Phase 2b trial for HIL-214, its investigational virus-like particle (VLP) based vaccine candidate, for the prevention of moderate-to-severe norovirus-related acute gastroenteritis (AGE) in infants. Based on this review, the DMC recommended continuation of NEST-IN1 without modification and enrollment has subsequently resumed. NEST-IN1 is a Phase 2b, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants of approximately 5 months of age at the 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 clinical trial protocol includes a prespecified 200 subject run-in to assess safety and immunogenicity. 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 a HIL-214 vaccine strain, GI.1 or GII.4, (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.