Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
Experimental	HIL-214	One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57

Primary Outcome Measures

Name	Time	Method
Safety of HIL-214 Compared to Placebo - AEs Leading to Trial Withdrawal	Day 1 to 6 months post-dose 2	Percentage of Participants with Adverse Events (AEs) Leading to Trial Withdrawal
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events	Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)	Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days of Vaccine Administration (any dose). Assessed AEs included pain, erythema, induration, and swelling.
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events	Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)	Percentage of Participants with Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Safety of HIL-214 Compared to Placebo - Percentage of Participants With AEs Leading to Vaccine Withdrawal	Up to 56 days post-dose 1	Percentage of participants with AEs that lead to withdrawal of trial vaccine up to the planned time of second dose administration.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity of HIL-214 Compared to Placebo.	Day 1 to 6 months post-dose 2	The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration) at Visit 2, Visit 3, and/or Visit 4 to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported. HBGA-blocking and pan-Ig assays were used for immunogenicity analyses.

Locations (4): Ohigesenseino Kodomo Clinic
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Sapporo-Shi, Japan
Fukui Aiiku Hospital
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Fukui-Shi, Japan
Iizuka Children's Clinic
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Iizuka-Shi, Japan
Childrens Clinic of Kose
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Kofu-Shi, Japan