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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05281094
Other study ID # NOR-212
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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