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 Locations

• United States
  • California
    • Rolling Hills Estates, California, United States, 90274
      • Pennisula Research Associates
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta

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	Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.	Day 1 to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Leading to Participant Withdrawal From the Trial	Adverse events leading to trial withdrawal were collected throughout the trial.	Day 1 to Day 85
Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration	Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.	Day 1 to Day 7
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration	Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.	Day 1 to Day 7
Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine	Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.	Day 1 to Day 28

Collaborators and Investigators

• Sponsor: HilleVax

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 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 (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

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