- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05281094
Efficacy and Safety of Two Doses of HIL-214 in Children
March 7, 2024 updated by: HilleVax
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
3085
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Lead
- Phone Number: 617-203-7722
- Email: clinical.trials@hillevax.com
Study Locations
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Distrito Capital
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Bogotá, Distrito Capital, Colombia
- Policlinico Social del Norte
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760042
- Cntro de Estudios en Infectologia Pediatrica (CEIP)
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Santo Domingo, Dominican Republic
- Clínica Cruz Jiminian
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Santo Domingo, Dominican Republic, 11102
- Hospital General Regional Marcelino Velez Santana
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Santo Domingo, Dominican Republic
- CAIMED - Dominican Center for Clinical Studies
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Santo Domingo, Dominican Republic
- Fundacion Dominicana de Perinatologia Pro Bebe
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Distrito Nacional
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Santo Domingo, Distrito Nacional, Dominican Republic
- Hospital Pediátrico Dr. Hugo Mendoza
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San Pedro Sula, Honduras
- Demedica
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Tegucigalpa, Honduras
- INVERIME - Inversiones en Investigación Medica
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Tegucigalpa, Honduras
- Investigación Sin Limite
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Ciudad de Panamá, Panama
- CEVAXIN Av. México
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La Chorrera, Panama
- Cevaxin La Chorrera
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Panama City, Panama, 00831
- CEVAXIN 24 Decembre
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Chiriqui
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David, Chiriqui, Panama, 00507
- CEVAXIN David
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Lima, Peru, 15024
- Instituto de Investigacion Nutricional
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Guayama, Puerto Rico
- Clinical Research Puerto Rico
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Texas
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Houston, Texas, United States, 77065
- DM Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 5 months (Child)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57.
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2 injections - given on Day 1 and the second given between Day 29 - Day 57
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Experimental: Experimental
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57.
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2 injections - given on Day 1 and the second given between Day 29 - Day 57
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Objective
Time Frame: From 4 weeks after second vaccination through the end of the surveillance period
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The number of subjects with moderate to severe AGE cases associated with GI.1 or GII.4 NoV genotypes.
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From 4 weeks after second vaccination through the end of the surveillance period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Objective
Time Frame: From 4 weeks after second vaccination through the end of the surveillance period
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The number of subjects with moderate to severe AGE associated only with ANY NoV genotypes
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From 4 weeks after second vaccination through the end of the surveillance period
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity Objectives
Time Frame: Through 28 days post Dose 2
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Titer results for HBGA blocking antibody test
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Through 28 days post Dose 2
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Immunogenicity Objectives - Secondary
Time Frame: Through 28 days post Dose 2
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Titer results for Pan-Ig antibody test
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Through 28 days post Dose 2
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Solicited Local AEs
Time Frame: Up to 7 days after each dose
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The number of subjects with solicited local AEs
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Up to 7 days after each dose
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Solicited Systemic AEs
Time Frame: Up to 7 days after each dose
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The number of subjects with solicited systemic AEs
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Up to 7 days after each dose
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Unsolicited Symptomatic AEs
Time Frame: Up to 28 days after each dose
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The number of subjects with unsolicited symptoms AEs
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Up to 28 days after each dose
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AEs Leading to Withdrawal
Time Frame: Up to 28 days after each dose
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The number AEs that lead to vaccine dose withdrawal
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Up to 28 days after each dose
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Adverse Events and Serious Adverse Events
Time Frame: Day 1 through end of trial, up to 2 years
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The number of AEs and SAEs that lead to the subject's withdrawal from the trial
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Day 1 through end of trial, up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2022
Primary Completion (Actual)
December 28, 2023
Study Completion (Estimated)
December 4, 2024
Study Registration Dates
First Submitted
February 17, 2022
First Submitted That Met QC Criteria
March 10, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOR-212
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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