Efficacy and Safety of Two Doses of HIL-214 in Children

NCT05281094 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: NOR-212
• Study Type: interventional
• Target: 3,084
• Locations: 7 countries
• Sites: 17

Brief Summary

This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes.

  Time to first occurrence during the primary observation period, of moderate/severe AGE case associated only with GI.1 or GII.4 norovirus genotypes. Vaccine efficacy (VE) is defined as 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. Samples that were positive for GI.1 or GII.4 genotypes were further analyzed for the presence of co-pathogens. VE estimates and 95% confidence intervals (CIs) are also reported.

  The duration of the primary observation period was 6 months starting at 28 days post dose 2.

Secondary Outcomes (8)

• To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup.

  The duration of the primary observation period was 6 months starting at 28 days post dose 2.

• To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens.

  The duration of the primary observation period was 6 months starting at 28 days post dose 2.

• To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens

  The duration of the primary observation period was 6 months starting at 28 days post dose 2.

• Immunogenicity of HIL-214 Compared to Placebo

  Participant reaches 1 year of age

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

  Up to 7 days after each dose of HIL-214 or placebo.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.

Biological: Placebo

Experimental

EXPERIMENTAL

One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.

Biological: HIL-214

Interventions

HIL-214 BIOLOGICAL

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

Experimental

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

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

You may qualify if:

• The subject should be 5 months of age (within plus or minus 14 days) male or female
• Children 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 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
• Children whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up

You may not qualify if:

• Clinically significant abnormality in growth by height, weight, or head circumference (according to local 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
• Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients)
• 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
• Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease)
• Individuals with 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 in the trial
• Known or suspected impairment/alteration of immune function
• Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
• Subjects who received or are scheduled to receive any other vaccines within 14 days (for inactivated vaccines and oral polio vaccine) or 28 days (for other live vaccines) before or after any dose of trial vaccine
• Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intend to participate in another clinical trial at any time during the conduct of this trial
• Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection
• Subject's LAR or subject's first-degree relatives involved in the trial conduct

Sponsors & Collaborators

• HilleVax: lead

Study Sites (17)

DM Clinical Research

Houston, Texas, 77065, United States

Location

Policlinico Social del Norte

Bogotá, Bogota D.C., Colombia

Location

Cntro de Estudios en Infectologia Pediatrica (CEIP)

Cali, Valle del Cauca Department, 760042, Colombia

Location

Hospital Pediátrico Dr. Hugo Mendoza

Santo Domingo, Nacional, Dominican Republic

Location

Hospital General Regional Marcelino Velez Santana

Santo Domingo, 11102, Dominican Republic

Location

CAIMED - Dominican Center for Clinical Studies

Santo Domingo, Dominican Republic

Location

Clínica Cruz Jiminian

Santo Domingo, Dominican Republic

Location

Fundacion Dominicana de Perinatologia Pro Bebe

Santo Domingo, Dominican Republic

Location

Demedica

San Pedro Sula, Honduras

Location

INVERIME - Inversiones en Investigación Medica

Tegucigalpa, Honduras

Location

Investigación Sin Limite

Tegucigalpa, Honduras

Location

CEVAXIN David

David, Chiriquí Province, 00507, Panama

Location

CEVAXIN La Chorrera

La Chorrera, Panama

Location

CEVAXIN 24 Decembre

Panama City, 00831, Panama

Location

CEVAXIN Av. México

Panama City, Panama

Location

Instituto de Investigacion Nutricional

Lima, 15024, Peru

Location

Clinical Research Puerto Rico

Guayama, Puerto Rico

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
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 16, 2022
• Study Start: April 28, 2022
• Primary Completion: December 28, 2023
• Study Completion: September 30, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-07

Locations

US (1); PR (1); CO (2); HO (3); DO (5); PA (4); PE (1)