Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults

Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years

The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis
• Intervention / Treatment: Biological: HIL-214

Detailed Description

This single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. Exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Lead; Phone Number: 617-203-7722; Email: clinical.trials@hillevax.com
• Study Contact Backup: Name: Clinical Lead; Phone Number: 6172037722; Email: clinical.trials@hillevax.com

Study Locations

• United States
  • California
    • Rolling Hills Estates, California, United States, 90274
      • Pennisula Research Associates
      • Contact: Dominique Venardi; Phone Number: 310-265-1623
      • Principal Investigator: Lawerence Sher, MD
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
      • Contact: Jennifer LeBrun; Phone Number: 770-507-6867
      • Principal Investigator: Deon Miller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female subjects aged 18 to 49 years, inclusive.
• Individuals 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 individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
• Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria:

• Females who are pregnant or breastfeeding.
• Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).
• Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).
• Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
• Any serious chronic or progressive disease (including hepatitis B or C).
• Previous exposure to an experimental norovirus vaccine.
• Subject or subject's first-degree relatives are involved in the trial conduct.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Arm Study; One dose given to all participants	Biological: HIL-214; HIL-214

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Immunogenicity for Panel Formation	For the 80 subjects enrolled in the trial, the serum samples that will be collected will be used to produce a proficient assay panel based on immunogenicity results of the initial testing. This panel that is formed will be used for further analysis in other clinical trials.	6 months

Collaborators and Investigators

• Sponsor: HilleVax

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: NOR-215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No