A Phase 2 interventional study of HIL-214 in Gastroenteritis, sponsored by HilleVax. Completed at 2 sites in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by HilleVax (part of Ligand Pharmaceuticals Incorporated) · Phase 2, Interventional, and Prevention
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.
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).
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's enrollment of 80 is below the median of 136 across 164 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →HilleVax is the lead sponsor of 4 studies on the registry; none are open to participants now.
First submitted before HilleVax became part of Ligand Pharmaceuticals Incorporated.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One dose given to all participants
Biological: HIL-214
HIL-214
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.
Time frame: Day 1 to Day 29
Adverse Events Leading to Participant Withdrawal From the Trial
Adverse events leading to trial withdrawal were collected throughout 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
Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 28
Participants took part in the trial at 2 investigative sites in the United States from 01 August 2023 to 10 November 2023.
| Milestone | HIL-214 |
|---|---|
| Started | 80 |
| Completed | 77 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Percentage of Participants | HIL-214 |
|---|---|
| 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) |
Adverse events leading to trial withdrawal were collected throughout the trial.
| Participants | HIL-214 |
|---|---|
| Adverse Events Leading to Participant Withdrawal From the Trial | 0 |
Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.
| percentage of participants | HIL-214 |
|---|---|
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration | 48.1 |
Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
| percentage of participants | HIL-214 |
|---|---|
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration | 55.7 |
Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.
| Participants | HIL-214 |
|---|---|
| Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine | 7 |
Collected over Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIL-214 | 0/80 (0%) | 0/80 (0%) | 52/79 (65.8%) |
| Event | HIL-214 |
|---|---|
| Injection site painInjury, poisoning and procedural complications | 35/79 |
| MyalgiaGeneral disorders | 31/79 |
| FatigueGeneral disorders | 27/79 |
| HeadacheGeneral disorders | 24/79 |
| ArthralgiaGeneral disorders | 11/79 |
| IndurationInjury, poisoning and procedural complications | 7/79 |
| DiarrheaGeneral disorders | 7/79 |
| RednessInjury, poisoning and procedural complications | 6/79 |
| SwellingInjury, poisoning and procedural complications | 4/79 |
| VomitingGeneral disorders | 4/79 |
Safety Analysis Set, all participants that received trial vaccine (HIL-214).
| Age, Categorical(Participants) | HIL-214 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 80 |
| >=65 years | 0 |
| Age, Continuous(years) | HIL-214 |
|---|---|
| Mean | 35.2 ± 9.21 |
| Sex: Female, Male(Participants) | HIL-214 |
|---|---|
| Female | 48 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | HIL-214 |
|---|---|
| Hispanic or Latino | 17 |
| Not Hispanic or Latino | 63 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | HIL-214 |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 40 |
| White | 31 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | HIL-214 |
|---|---|
| United States | 80 |
| Weight(kg) | HIL-214 |
|---|---|
| Mean | 87.32 ± 24.573 |
| Height(cm) | HIL-214 |
|---|---|
| Mean | 170.70 ± 10.822 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2023 to primary completion in Aug 2023, 0 months.
Results were first posted in Aug 2025, 2 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: HIL-214