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

• ClinicalTrials.gov Identifier: NCT05281094
• Recruitment Status: Active, not recruiting
• First Posted: March 16, 2022
• Last Update Posted: March 8, 2024
• Sponsor: HilleVax
• Information provided by (Responsible Party): HilleVax

Tracking Information

• First Submitted Date: February 17, 2022
• First Posted Date: March 16, 2022
• Last Update Posted Date: March 8, 2024
• Actual Study Start Date: March 16, 2022
• Actual Primary Completion Date: December 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2022)

Primary Objective [ Time Frame: From 4 weeks after second vaccination through the end of the surveillance period ]

The number of subjects with moderate to severe AGE cases associated with GI.1 or GII.4 NoV genotypes.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 23, 2023)

Secondary Objective [ Time Frame: From 4 weeks after second vaccination through the end of the surveillance period ]

The number of subjects with moderate to severe AGE associated only with ANY NoV genotypes

Original Secondary Outcome Measures (submitted: March 10, 2022)

Key Secondary Objective [ Time Frame: From 4 weeks after second vaccination through the end of the surveillance period ]

The number of subjects with moderate to severe AGE cases associated with GI.1 or GII.4 NoV genotypes.

Current Other Pre-specified Outcome Measures (submitted: March 10, 2022)

• Immunogenicity Objectives [ Time Frame: Through 28 days post Dose 2 ]
  Titer results for HBGA blocking antibody test
• Immunogenicity Objectives - Secondary [ Time Frame: Through 28 days post Dose 2 ]
  Titer results for Pan-Ig antibody test
• Solicited Local AEs [ Time Frame: Up to 7 days after each dose ]
  The number of subjects with solicited local AEs
• Solicited Systemic AEs [ Time Frame: Up to 7 days after each dose ]
  The number of subjects with solicited systemic AEs
• Unsolicited Symptomatic AEs [ Time Frame: Up to 28 days after each dose ]
  The number of subjects with unsolicited symptoms AEs
• AEs Leading to Withdrawal [ Time Frame: Up to 28 days after each dose ]
  The number AEs that lead to vaccine dose withdrawal
• Adverse Events and Serious Adverse Events [ Time Frame: Day 1 through end of trial, up to 2 years ]
  The number of AEs and SAEs that lead to the subject's withdrawal from the trial

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Efficacy and Safety of Two Doses of HIL-214 in Children
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Gastroenteritis

Intervention

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

Study Arms

• Placebo Comparator: Placebo
  One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57.
  Intervention: Biological: Placebo
• Experimental: Experimental
  One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57.
  Intervention: Biological: HIL-214

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 2, 2023): 3085
• Original Estimated Enrollment (submitted: March 10, 2022): 3000
• Estimated Study Completion Date: December 4, 2024
• Actual Primary Completion Date: December 28, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Months to 5 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Colombia, Dominican Republic, Honduras, Panama, Peru, Puerto Rico, United States
• Removed Location Countries: Mexico

Administrative Information

• NCT Number: NCT05281094
• Other Study ID Numbers: NOR-212
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: HilleVax
• Original Responsible Party: Same as current
• Current Study Sponsor: HilleVax
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: HilleVax
• Verification Date: March 2024