Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants

NCT06007781 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: NOR-109
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (4)

• Safety of HIL-214 Compared to Placebo - AEs Leading to Trial Withdrawal

  Percentage of Participants with Adverse Events (AEs) Leading to Trial Withdrawal

  Day 1 to 6 months post-dose 2

• Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events

  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.

  Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)

• Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events

  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.

  Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)

• Safety of HIL-214 Compared to Placebo - Percentage of Participants With AEs Leading to Vaccine Withdrawal

  Percentage of participants with AEs that lead to withdrawal of trial vaccine up to the planned time of second dose administration.

  Up to 56 days post-dose 1

Secondary Outcomes (1)

• Immunogenicity of HIL-214 Compared to Placebo.

  Day 1 to 6 months post-dose 2

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57

Biological: Placebo

Experimental

EXPERIMENTAL

One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57

Biological: HIL-214

Interventions

Placebo BIOLOGICAL

2 injections - given on Day 1 and the second given between Day 29 - Day 57

Placebo

HIL-214 BIOLOGICAL

2 injections - given on Day 1 and the second given between Day 29 - Day 57

Experimental

Eligibility Criteria

• Age: 5 Months - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subject aged 5 months \[-14/+14 days\].
• Infants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
• The subject's legally acceptable representative (LAR) signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
• The subject's LAR is willing and able to comply with trial procedures and is available for the duration of follow-up.

You may not qualify if:

• Clinically significant abnormality in growth by length/height, weight, or head circumference (according to national guidelines).
• Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
• Chronic use of oral corticosteroids (equivalent to 20 mg/day prednisolone for ≥12 weeks / ≥2 mg/kg body weight /day for ≥2 weeks) within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids are allowed).
• Use of parenteral corticosteroids (equivalent to 20 mg/day prednisolone for ≥12 weeks / ≥2 mg/kg body weight /day for ≥2 weeks. Use of inhaled, intranasal, or topical corticosteroid is allowed) within 60 days prior to Visit 1.
• Receipt of immunostimulants within 60 days prior to Visit 1.
• Receipt of parenteral, epidural, or intra-articular immunoglobulin (Ig) preparations, blood products, and/or plasma derivatives within 90 days prior to Visit 1 or planned during the full duration of the trial.
• Receipt of immunosuppressive therapy prior to Visit 1.
• Known hypersensitivity or allergy to any of the trial vaccine components (including excipients).
• Any clinically significant active infection (as assessed by the investigator) or temperature ≥38.0°C (\>100.4°F), regardless of method used, within 3 days prior to intended trial vaccine administration.
• Gastroenteritis within 7 days before planned dosing (can warrant delay of trial vaccine administration).
• History of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation the trial.
• Abnormalities of splenic or thymic function.
• Known or suspected impairment/alteration of immune function.
• Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• Receipt or scheduled receipt of any other approved or authorized vaccines within 14 days (for all non-live vaccines or oral live vaccines) or 28 days (for parenteral live vaccines) before or after trial vaccine administration.

Sponsors & Collaborators

• HilleVax: lead

Study Sites (4)

Fukui Aiiku Hospital

Fukui-shi, 910-0833, Japan

Location

Iizuka Children's Clinic

Iizuka-Shi, 820-0040, Japan

Location

Childrens Clinic of Kose

Kofu, 400-0853, Japan

Location

Ohigesenseino Kodomo Clinic

Sapporo, 062-0907, Japan

Location

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Astrid Borkowski, Chief Medical Officer
• Organization: HilleVax, Inc.

aborkowski@hillevax.com

+1 (617) 213-6562

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be allocated (2 to1) into one of two trial arms, Arm 1 - One dose of HIL-214; Arm 2 - One dose of placebo.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 23, 2023
• Study Start: August 18, 2023
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Locations

JP (4)