GastroenteritisPhase 2NCT05972733

Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults

A Phase 2 study testing HIL-214 in people with Gastroenteritis, run by HilleVax at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Gastroenteritis
What is being tested?: HIL-214
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 2 sitesUnited States
Study dates: 1 Aug 2023to 10 Nov 2023
Phase: Phase 2
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 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects aged 18 to 49 years, inclusive.
Individuals 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 individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.

Who cannot join

Females who are pregnant or breastfeeding.
Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).
Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).
Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
Any serious chronic or progressive disease (including hepatitis B or C).
Previous exposure to an experimental norovirus vaccine.
Subject or subject's first-degree relatives are involved in the trial conduct.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Pennisula Research Associates
Rolling Hills Estates, California, 90274
Clinical Research Atlanta
Stockbridge, Georgia, 30281

Other trials in United States

About this study

Official title: Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years

The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.

Read the detailed description

This single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. Exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).

Conditions: Gastroenteritis
Being tested: 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.

HIL-214Biological
HIL-214

Study groups in NCT05972733
Study group	Role	What they receive
Open Arm Study	Experimental	One dose given to all participants Receives: Biological: HIL-214

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Immunogenicity for Panel Formation
Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.
Measured: Day 1 to Day 29

Secondary outcomes (4)

Adverse Events Leading to Participant Withdrawal From the Trial
Adverse events leading to trial withdrawal were collected throughout the trial.
Measured: Day 1 to Day 85
Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration
Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.
Measured: Day 1 to Day 7
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration
Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Measured: Day 1 to Day 7
Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine
Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.
Measured: Day 1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202310 Nov 2023

First posted2 Aug 2023
Study start1 Aug 2023
Primary completion14 Aug 2023
Study completion10 Nov 2023

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 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Single-arm, Open-label Trial
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05972733
Sponsor's protocol ID: NOR-215
Status last verified: Jul 2025
First submitted: 11 Jul 2023
Last updated: 19 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years
ClinicalTrials.gov ID: NCT05972733
Acronym / sponsor ID: NOR-215
Conditions: Gastroenteritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: HilleVaxIndustry (pharma, biotech, devices)
Study start: 1 Aug 2023 (actual)
Primary completion: 14 Aug 2023 (actual)
Study completion: 10 Nov 2023 (actual)
First posted: 2 Aug 2023 (actual)
Results: Posted 19 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-arm, Open-label Trial

Arm	Type	Receives
Open Arm Study	Experimental	Biological: HIL-214One dose given to all participants

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male or female subjects aged 18 to 49 years, inclusive.
Individuals 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 individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.

Key exclusion criteria (7 listed)

Females who are pregnant or breastfeeding.
Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).
Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).
Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
Any serious chronic or progressive disease (including hepatitis B or C).

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
HIL-214HIL-214	Biological	Open Arm Study

Primary outcome

Primary Immunogenicity for Panel Formation
Time frame: Day 1 to Day 29
Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.

4 secondary outcomes

Adverse Events Leading to Participant Withdrawal From the Trial
Time frame: Day 1 to Day 85
Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration
Time frame: Day 1 to Day 7
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration
Time frame: Day 1 to Day 7
Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine
Time frame: Day 1 to Day 28

Results and safety

Results posted to the registry on 19 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIL-214	80	77

Primary outcome: Primary Immunogenicity for Panel Formation

Time frame: Day 1 to Day 29. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	HIL-214 n = 78
Anti-GI.1 HBGA-blocking seroresponse rate	87.0 (77.4 to 93.6)
Anti-GII.4c HBGA-blocking seroresponse rate	72.7 (61.4 to 82.3)
Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate	60.5 (48.6 to 71.6)
Anti-GI.1 pan-Ig seroresponse rate	98.7 (93.1 to 100)
Anti-GII.4c pan-Ig seroresponse rate	91.0 (82.4 to 96.3)
Anti-GI.1 and GII.4c pan-Ig seroresponse rate	91.0 (82.4 to 96.3)

Population analysed: Safety Analysis Set, all participants that received trial vaccine (HIL-214).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIL-214	0 of 80 (0%)	52 of 79 (65.8%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HIL-214 in people with Gastroenteritis, run by HilleVax at 2 sites in United States.

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 7 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 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Aug 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?

Primary Immunogenicity for Panel Formation (time frame: Day 1 to Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05972733.

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 19 Aug 2025.