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

NCT ID: NCT05281094

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3084 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2024-09-30

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.

Detailed Description

Noroviruses have emerged as the single most significant cause of gastroenteritis in both middle-high income countries and low resource settings worldwide. Those most at risk of severe illness include the very young, the elderly and immunocompromised individuals. Noroviruses are highly infectious, highly resistant to environmental conditions, and have multiple routes of transmission including person-to-person, food-borne and contaminated surfaces. Noroviruses can cause acute, mild to severe illness characterized by vomiting, diarrhea, fever, dehydration and abdominal pain, representing a significant burden to public health. The clinical presentation in adults and older children is similar. While mortality due to acute gastroenteritis (AGE) caused by norovirus in the pediatric population is rare in industrialized countries, it is more common in developing countries. Although potentially a cause for hospitalization in very young children, there are fewer cases during the first 6 months of life possibly due to the protection offered by maternal antibodies from trans-placental transfer and in breast milk. In addition, norovirus infections have significant socioeconomic impact on hospitals, schools, day care centers and other closed settings. 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 AGE in many countries around the world.

Conditions

Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Experimental

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

Group Type: EXPERIMENTAL

HIL-214

Intervention Type: BIOLOGICAL

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

Interventions

HIL-214

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 5 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HilleVax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DM Clinical Research

Houston, Texas, United States

Policlinico Social del Norte

Bogotá, Bogota D.C., Colombia

Cntro de Estudios en Infectologia Pediatrica (CEIP)

Cali, Valle del Cauca Department, Colombia

Hospital Pediátrico Dr. Hugo Mendoza

Santo Domingo, Nacional, Dominican Republic

Hospital General Regional Marcelino Velez Santana

Santo Domingo, , Dominican Republic

CAIMED - Dominican Center for Clinical Studies

Santo Domingo, , Dominican Republic

Clínica Cruz Jiminian

Santo Domingo, , Dominican Republic

Fundacion Dominicana de Perinatologia Pro Bebe

Santo Domingo, , Dominican Republic

Demedica

San Pedro Sula, , Honduras

INVERIME - Inversiones en Investigación Medica

Tegucigalpa, , Honduras

Investigación Sin Limite

Tegucigalpa, , Honduras

CEVAXIN David

David, Chiriquí Province, Panama

CEVAXIN La Chorrera

La Chorrera, , Panama

CEVAXIN 24 Decembre

Panama City, , Panama

CEVAXIN Av. México

Panama City, , Panama

Instituto de Investigacion Nutricional

Lima, , Peru

Clinical Research Puerto Rico

Guayama, , Puerto Rico

Countries

United States; Colombia; Dominican Republic; Honduras; Panama; Peru; Puerto Rico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NOR-212

Identifier Type: -

Identifier Source: org_study_id