HilleVax, Inc. announced completion of enrollment of NEST-IN1 (Norovirus Efficacy and Safety Trial for INfants), with over 3,000 subjects enrolled in six countries. NEST-IN1 is the company's ongoing 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. Topline safety and clinical efficacy data from NEST-IN1 are expected in the first quarter of 2024.

About NEST-IN1 NEST-IN1 is a Phase 2b clinical trial to evaluate the efficacy, safety and immunogenicity of HIL-214 in over 3,000 infants. This clinical trial is a randomized, double-blind, placebo-controlled trial in infants of approximately 5 months of age at time of initial vaccination at sites in the United States and Latin America. Subjects were randomized 1:1 to receive either HIL-214 or placebo.

In the vaccine arm, subjects received HIL-214 (50/150 ug GI.1/GII.4 VLP combination with 500 ug alum) in a two-dose regimen delivered 28 to 56 days apart.