GastroenteritisPhase 1NCT06007781
Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants
A Phase 1 study testing HIL-214 in people with Gastroenteritis, run by HilleVax at 4 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- HIL-214
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 4 sitesJapan
- Study dates
- 18 Aug 2023to 27 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Participation in any clinical trial with another investigational product 30 days prior to first trial visit or intention to participate in another clinical trial at any time during the conduct of this trial.
- Seropositive for, or in evaluation for, possible human immunodeficiency virus infection.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Fukui Aiiku Hospital
Fukui-shi, 910-0833
Iizuka Children's Clinic
Iizuka-Shi, 820-0040
Childrens Clinic of Kose
Kofu, 400-0853
Ohigesenseino Kodomo Clinic
Sapporo, 062-0907
About this study
Official title: 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
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.
Read the 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
- Being tested
- Placebo, HIL-214
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
2 injections - given on Day 1 and the second given between Day 29 - Day 57
HIL-214Biological
2 injections - given on Day 1 and the second given between Day 29 - Day 57
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57 Receives: Biological: Placebo |
| Experimental | Experimental | One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57 Receives: Biological: HIL-214 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of HIL-214 Compared to Placebo - AEs Leading to Trial Withdrawal
Percentage of Participants with Adverse Events (AEs) Leading to Trial Withdrawal
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 56 days post-dose 1
Secondary outcomes (1)
Immunogenicity of HIL-214 Compared to Placebo.
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.
Measured: Day 1 to 6 months post-dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start18 Aug 2023
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- HilleVax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007781
- Sponsor's protocol ID
- NOR-109
- Status last verified
- Feb 2025
- First submitted
- 15 Aug 2023
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06007781
- Acronym / sponsor ID
- NOR-109
- Conditions
- Gastroenteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- HilleVaxIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboOne dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57 |
| Experimental | Experimental | Biological: HIL-214One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57 |
Who may qualify
- Ages
- 5 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo2 injections - given on Day 1 and the second given between Day 29 - Day 57 | Biological | Placebo |
| HIL-2142 injections - given on Day 1 and the second given between Day 29 - Day 57 | Biological | Experimental |
Primary outcome
Safety of HIL-214 Compared to Placebo - AEs Leading to Trial Withdrawal
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Immunogenicity of HIL-214 Compared to Placebo.
Time frame: Day 1 to 6 months post-dose 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIL-214 in people with Gastroenteritis, run by HilleVax at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of HIL-214 Compared to Placebo - AEs Leading to Trial Withdrawal (time frame: Day 1 to 6 months post-dose 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.