NCT06007781

Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants

A Phase 1, Randomized, Double-blind, Multi-center, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Healthy Japanese Infants 5 Months of Age at First Trial Vaccine Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: HilleVax · Industry
• Sex: All
• Age: 5 Months – 5 Months
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.

Detailed description

The rationale for trial NOR-109 is to evaluate the safety and immunogenicity of HIL-214 in Japanese pediatric subjects and establish whether the data obtained is consistent with that previously obtained for non-Japanese pediatric subjects. The clinical trials for HIL-214 have so far been performed in Europe, the United States and several countries in Latin America \[26\]. The incidence rate of norovirus-attributable disease in Japan is at least as high as in other developed countries with the highest rates occurring in children below the age of 5 years and hospitalization most common in very young and very old populations. The inclusion of infants (5 months \[±14 days\] of age at the time of first trial vaccine administration) serves to compare the data obtained for infants of non-Japanese descent with Japanese infants, in alignment with the global clinical program, and to support the inclusion of Japanese infants into phase 3. Enrollment and vaccination of the infants will be performed either before or after the required routine childhood vaccines per the national immunization schedule. This phase 1 trial in Japan aims to assess the safety and immunogenicity of two doses of HIL-214 administered 4 to 8 weeks apart, in 21 healthy infants aged 5 months at the time of the first trial vaccine dose administration. A placebo arm is included to allow an unbiased assessment of safety and immunogenicity.

Conditions

• Gastroenteritis

Interventions

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

Timeline

• Start date: 2023-08-18
• Primary completion: 2024-05-27
• Completion: 2024-05-27
• First posted: 2023-08-23
• Last updated: 2025-03-14
• Results posted: 2025-03-14

Locations

4 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study