A Phase 2/3 interventional study of HIL-214 and Placebo in Gastroenteritis, sponsored by HilleVax. Completed at 12 sites in 3 countries. Open to participants aged 2 Months to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by HilleVax (part of Ligand Pharmaceuticals Incorporated) · Phase 2/3, Interventional, and Prevention
This is a phase 2, multi-country, randomized, double-blind, placebo-controlled trial to evaluate the immune response to routine pediatric vaccinations when co-administered with HIL-214 or placebo in healthy infants. This trial will also evaluate the safety profile of a 2-dose regimen of HIL-214 co-administered with routine pediatric vaccines.
Epidemiologic studies have shown that gastroenteritis in infants is associated with several viruses, including norovirus, sapovirus and rotavirus. These viruses together or individually can be associated with illness ranging from asymptomatic to serious. Asymptomatic infection can create a reservoir, allowing further spread of the virus, whereas serious illness can lead to death, particularly in the very young, very old or immunocompromised. As the burden of rotavirus in children decreases due to successful rotavirus vaccination programs in infants, norovirus infections are increasingly recognized as the primary cause of acute gastroenteritis (AGE) in many countries around the world. Currently, there is no available vaccine to counter the disease burden associated with norovirus. Vaccinating at an early age would reduce the severe illness in young children and also reduce the asymptomatic cases which act as a vehicle for transmission within the population. As infants already receive multiple vaccines during the first months of life, an additional vaccination must fit into the immunization scheme in a convenient way for compliance. It must also have an acceptable safety profile and be immunogenic without interfering with the immune response to routine childhood vaccines.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's enrollment of 329 is above 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:
Any clinically significant active infection (as assessed by the investigator) or temperature
≥38.0°C (>100.4°F), within 3 days of intended trial vaccination.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIL-214 (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.
Biological: HIL-214
Placebo (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.
Biological: Placebo
2 injections - given at 4 months and the second at 6 months of age.
2 injections - given at 4 months and the second at 6 months of age.
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis \[FHA\], \[PRN\] and \[PTX\]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
Time frame: 28 days post-dose 2
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: Geometric mean anti-FHA, anti-PRN, and anti-PTX concentrations
Time frame: 28 days post-dose 2
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG \[serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F\]) at 28 days post-dose. Geometric mean concentrations are presented.
Time frame: 28 days post-dose 2
Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported.
Time frame: 28 days post-dose 2
Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.
Anti-norovirus (GI.1 and GII.4c) HBGA-blocking antibodies were measured at prior to dose 1 (\~4 months of age) and 28 days post-dose 2 (\~6 months of age). Seroresponse was defined as a fold increase from baseline greater than or equal to 4. Seroresponse rates and 95% confidence intervals (CIs) are presented. Data are stratified by country (Panama and USA).
Time frame: Pre-dose 1 and 28 days post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with solicited local (injection site) reactions within 7 days of any vaccine administration. Assessed reactions included pain, redness, induration, and swelling.
Time frame: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with solicited systemic adverse events (AEs) within 7 days of any vaccine administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Time frame: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with adverse events (AEs) leading to vaccine discontinuation or trial withdrawal.
Time frame: Day 1 to 28 days post-dose 1 (vaccine discontinuation); Day 1 to 12 months post-dose 1
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo
Percentage of participants with medically attended adverse events (AEs) at any point during the trial.
Time frame: Day 1 to 12 months post-dose 1
Participants took part in the trial at 10 investigative sites in Panama and the United States from 10 June 2023 to 08 July 2024.
| Milestone | Placebo | HIL-214 |
|---|---|---|
| Started | 164 | 165 |
| Completed | 160 | 161 |
| Not completed | 4 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Reason not included in pre-specified categories | 2 | 1 |
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis \[FHA\], \[PRN\] and \[PTX\]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
| percentage of participants | Placebo (Panama) | HIL-214 (Panama) | Placebo (USA) | HIL-214 (USA) |
|---|---|---|---|---|
| Anti-diphtheria toxoid IgG concentration ≥0.1 IU/mL. | 99.3 | 100 | 100 | 100 |
| Anti-tetanus toxoid IgG concentration ≥0.1 IU/mL | 100 | 100 | 100 | 100 |
| Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2 | 100 | 100 | 100 | 83.3 |
| Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2 | 100 | 100 | 100 | 100 |
| Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2 | 99.3 | 99.2 | 100 | 100 |
| Anti-PRP IgG concentration ≥ 0.15 ug/mL | 100 | 100 | 100 | 100 |
| Anti-HBsAg IgG concentration ≥10 mIU/mL | 100 | 100 | 100 | 100 |
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: Geometric mean anti-FHA, anti-PRN, and anti-PTX concentrations
| IU/mL | Placebo (Panama) | HIL-214 (Panama) | Placebo (USA) | HIL-214 (USA) |
|---|---|---|---|---|
| Anti-pertussis FHA concentration | 83.958 ± 1.8338 | 78.726 ± 1.8566 | 32.515 ± 2.9346 | 26.358 ± 2.7499 |
| Anti-pertactin (PRN) concentration | 92.605 ± 2.1811 | 84.617 ± 2.2496 | 61.222 ± 2.6526 | 43.417 ± 2.7743 |
| Anti-pertussis toxin (PTX) concentration | 48.536 ± 1.8552 | 48.906 ± 2.0150 | 80.713 ± 2.2249 | 43.066 ± 2.5144 |
The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG \[serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F\]) at 28 days post-dose. Geometric mean concentrations are presented.
| ug/mL | Placebo | HIL-214 |
|---|---|---|
| Anti-pneumococcal IgG concentration for serotype 1 | 5.255 ± 1.9827 | 5.802 ± 2.2008 |
| Anti-pneumococcal IgG concentration for serotype 3 | 0.777 ± 2.3728 | 0.747 ± 2.2117 |
| Anti-pneumococcal IgG concentration for serotype 4 | 2.958 ± 1.8468 | 2.773 ± 2.0253 |
| Anti-pneumococcal IgG concentration for serotype 5 | 2.378 ± 1.9223 | 2.429 ± 1.9277 |
| Anti-pneumococcal IgG concentration for serotype 6A | 7.660 ± 2.0384 | 7.414 ± 2.2194 |
| Anti-pneumococcal IgG concentration for serotype 6B | 6.419 ± 2.3854 | 5.459 ± 2.7604 |
| Anti-pneumococcal IgG concentration for serotype 7F | 5.091 ± 1.6726 | 5.063 ± 1.7727 |
| Anti-pneumococcal IgG concentration for serotype 9V | 3.881 ± 1.9259 | 3.568 ± 2.1651 |
| Anti-pneumococcal IgG concentration for serotype 14 | 11.819 ± 2.3158 | 12.017 ± 2.3278 |
| Anti-pneumococcal IgG concentration for serotype 19A | 3.203 ± 2.0635 | 3.069 ± 1.9742 |
| Anti-pneumococcal IgG concentration for serotype 19F | 5.822 ± 2.0030 | 5.487 ± 2.1713 |
| Anti-pneumococcal IgG concentration for serotype 18C | 2.997 ± 1.8435 | 3.040 ± 1.9344 |
| Anti-pneumococcal IgG concentration for serotype 23F | 2.885 ± 2.5878 | 2.543 ± 2.7745 |
This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported.
| U/mL | Placebo | HIL-214 |
|---|---|---|
| Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 67.772 ± 4.0633 | 87.694 ± 4.2618 |
Anti-norovirus (GI.1 and GII.4c) HBGA-blocking antibodies were measured at prior to dose 1 (\~4 months of age) and 28 days post-dose 2 (\~6 months of age). Seroresponse was defined as a fold increase from baseline greater than or equal to 4. Seroresponse rates and 95% confidence intervals (CIs) are presented. Data are stratified by country (Panama and USA).
| percentage of participants | Placebo (Panama) | HIL-214 (Panama) | Placebo (USA) | HIL-214 (USA) |
|---|---|---|---|---|
| Anti-GI.1 seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 4.1 (1.3 to 9.2) | 97.5 (92.7 to 99.5) | 0 (0.0 to 45.9) | 100 (59.0 to 100) |
| Anti-GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 1.6 (0.2 to 5.8) | 51.3 (41.9 to 60.5) | 0 (0.0 to 52.5) | 16.7 (0.4 to 64.1) |
| Anti-GI.1 and GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 0.8 (0.0 to 4.5) | 53.0 (43.5 to 62.4) | 0 (0.0 to 52.2) | 16.7 (0.4 to 64.1) |
Percentage of participants with solicited local (injection site) reactions within 7 days of any vaccine administration. Assessed reactions included pain, redness, induration, and swelling.
| percentage of participants | Placebo | HIL-214 |
|---|---|---|
| Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 38.4 | 41.2 |
Percentage of participants with solicited systemic adverse events (AEs) within 7 days of any vaccine administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
| percentage of participants | Placebo | HIL-214 |
|---|---|---|
| Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 54.9 | 46.1 |
Percentage of participants with adverse events (AEs) leading to vaccine discontinuation or trial withdrawal.
| percentage of participants | Placebo | HIL-214 |
|---|---|---|
| AE leading to vaccine discontinuation | 0 | 0 |
| AE leading to trial withdrawal | 0 | 0 |
Percentage of participants with medically attended adverse events (AEs) at any point during the trial.
| percentage of participants | Placebo | HIL-214 |
|---|---|---|
| Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo | 63.4 | 65.5 |
Collected over Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/164 (0%) | 7/164 (4.3%) | 81/164 (49.4%) |
| HIL-214 | 0/165 (0%) | 3/165 (1.8%) | 77/165 (46.7%) |
| Event | Placebo | HIL-214 |
|---|---|---|
| BronchiolitisInfections and infestations | 3/164 | 1/165 |
| Pneumonia respiratory syncytial virusInfections and infestations | 2/164 | 0/165 |
| PneumoniaInfections and infestations | 1/164 | 1/165 |
| Urinary tract infectionInfections and infestations | 1/164 | 0/165 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/164 | 1/165 |
| Event | Placebo | HIL-214 |
|---|---|---|
| NasopharyngitisInfections and infestations | 64/164 | 55/165 |
| GastroenteritisInfections and infestations | 5/164 | 10/165 |
| PyrexiaGeneral disorders | 8/164 | 4/165 |
| BronchiolitisInfections and infestations | 4/164 | 8/165 |
Randomized Analysis Set; All participants that were randomized.
| Age, Categorical(Participants) | Placebo | HIL-214 | Total |
|---|---|---|---|
| <=18 years | 164 | 165 | 329 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(days) | Placebo | HIL-214 | Total |
|---|---|---|---|
| Mean | 125.7 ± 4.35 | 125.6 ± 4.48 | 125.7 ± 4.41 |
| Sex: Female, Male(Participants) | Placebo | HIL-214 | Total |
|---|---|---|---|
| Female | 82 | 82 | 164 |
| Male | 82 | 83 | 165 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | HIL-214 | Total |
|---|---|---|---|
| Hispanic or Latino | 159 | 160 | 319 |
| Not Hispanic or Latino | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | HIL-214 | Total |
|---|---|---|---|
| Race/Ethnicity — American Indian or Alaskan Native | 1 | 0 | 1 |
| Race/Ethnicity — Black or African American | 2 | 1 | 3 |
| Race/Ethnicity — White | 9 | 9 | 18 |
| Race/Ethnicity — More than one race | 151 | 154 | 305 |
| Race/Ethnicity — Other | 1 | 1 | 2 |
| Region of Enrollment(participants) | Placebo | HIL-214 | Total |
|---|---|---|---|
| United States | 14 | 13 | 27 |
| Panama | 150 | 152 | 302 |
| Prior Vaccinations(Participants) | Placebo | HIL-214 | Total |
|---|---|---|---|
| Yes | 163 | 161 | 324 |
| No | 1 | 4 | 5 |
| Breastfeeding Status(Participants) | Placebo | HIL-214 | Total |
|---|---|---|---|
| Breastfeeding | 143 | 146 | 289 |
| Not breastfeeding | 21 | 19 | 40 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: HIL-214