HilleVax Reports Positive Immunogenicity Results For Phase 2b Trial For HIL-214
(RTTNews) - Biopharmaceutical company HilleVax, Inc. (HLVX) reported Monday positive results from a prespecified immunogenicity analysis of the 203 subjects enrolled in the run-in cohort of NEST-IN1 (Norovirus Efficacy and Safety Trial for INfants), 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.
These results follow the previously announced positive recommendation from an independent safety data monitoring committee based on this same cohort.
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 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 company said the full NEST-IN1 topline safety and efficacy data remains on-track for the second half of 2023.
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