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

Gastroenteritis Clinical Trial

Official title:

A Phase 2b, Double-blind, Randomized, Multi-site, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Immunogenicity of Intramuscular HIL-214 Norovirus Vaccine in Healthy Children 5 Months of Age at Initial Vaccination

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05281094
• Other study ID #: NOR-212
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: March 16, 2022
• Est. completion date: December 4, 2024

Study information

• Verified date: March 2024
• Source: HilleVax
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3085
• Est. completion date: December 4, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

Biological:
• HIL-214
2 injections - given on Day 1 and the second given between Day 29 - Day 57
• Placebo
2 injections - given on Day 1 and the second given between Day 29 - Day 57

Locations

Country	Name	City	State
Colombia	Policlinico Social del Norte	Bogotá	Distrito Capital
Colombia	Cntro de Estudios en Infectologia Pediatrica (CEIP)	Cali	Valle Del Cauca
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	Hospital General Regional Marcelino Velez Santana	Santo Domingo
Dominican Republic	Hospital Pediátrico Dr. Hugo Mendoza	Santo Domingo	Distrito Nacional
Honduras	Demedica	San Pedro Sula
Honduras	INVERIME - Inversiones en Investigación Medica	Tegucigalpa
Honduras	Investigación Sin Limite	Tegucigalpa
Panama	CEVAXIN Av. México	Ciudad de Panamá
Panama	CEVAXIN David	David	Chiriqui
Panama	CEVAXIN La Chorrera	La Chorrera
Panama	CEVAXIN 24 Decembre	Panama City
Peru	Instituto de Investigacion Nutricional	Lima
Puerto Rico	Clinical Research Puerto Rico	Guayama
United States	DM Clinical Research	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
HilleVax

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunogenicity Objectives	Titer results for HBGA blocking antibody test	Through 28 days post Dose 2
Other	Immunogenicity Objectives - Secondary	Titer results for Pan-Ig antibody test	Through 28 days post Dose 2
Other	Solicited Local AEs	The number of subjects with solicited local AEs	Up to 7 days after each dose
Other	Solicited Systemic AEs	The number of subjects with solicited systemic AEs	Up to 7 days after each dose
Other	Unsolicited Symptomatic AEs	The number of subjects with unsolicited symptoms AEs	Up to 28 days after each dose
Other	AEs Leading to Withdrawal	The number AEs that lead to vaccine dose withdrawal	Up to 28 days after each dose
Other	Adverse Events and Serious Adverse Events	The number of AEs and SAEs that lead to the subject's withdrawal from the trial	Day 1 through end of trial, up to 2 years
Primary	Primary Objective	The number of subjects with moderate to severe AGE cases associated with GI.1 or GII.4 NoV genotypes.	From 4 weeks after second vaccination through the end of the surveillance period
Secondary	Secondary Objective	The number of subjects with moderate to severe AGE associated only with ANY NoV genotypes	From 4 weeks after second vaccination through the end of the surveillance period