NCT05281094

Efficacy and Safety of Two Doses of HIL-214 in Children

A Phase 2b, Double-blind, Randomized, Multi-site, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Immunogenicity of Intramuscular HIL-214 Norovirus Vaccine in Healthy Children 5 Months of Age at Initial Vaccination

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,084 (actual)
• Sponsor: HilleVax · Industry
• Sex: All
• Age: 5 Months – 5 Months
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.

Detailed description

Noroviruses have emerged as the single most significant cause of gastroenteritis in both middle-high income countries and low resource settings worldwide. Those most at risk of severe illness include the very young, the elderly and immunocompromised individuals. Noroviruses are highly infectious, highly resistant to environmental conditions, and have multiple routes of transmission including person-to-person, food-borne and contaminated surfaces. Noroviruses can cause acute, mild to severe illness characterized by vomiting, diarrhea, fever, dehydration and abdominal pain, representing a significant burden to public health. The clinical presentation in adults and older children is similar. While mortality due to acute gastroenteritis (AGE) caused by norovirus in the pediatric population is rare in industrialized countries, it is more common in developing countries. Although potentially a cause for hospitalization in very young children, there are fewer cases during the first 6 months of life possibly due to the protection offered by maternal antibodies from trans-placental transfer and in breast milk. In addition, norovirus infections have significant socioeconomic impact on hospitals, schools, day care centers and other closed settings. As the burden of rotavirus in children decreases due to successful rotavirus vaccination programs in infants, norovirus infections are increasingly recognized as the primary cause of AGE in many countries around the world.

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	HIL-214	2 injections - given on Day 1 and the second given between Day 29 - Day 57
BIOLOGICAL	Placebo	2 injections - given on Day 1 and the second given between Day 29 - Day 57

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-12-28
• Completion: 2024-09-30
• First posted: 2022-03-16
• Last updated: 2025-07-10
• Results posted: 2025-07-10

Locations

17 sites across 7 countries: United States, Colombia, Dominican Republic, Honduras, Panama, Peru, Puerto Rico

Regulatory

• FDA-regulated drug study