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

NCT05972733 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NOR-215
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adverse Events Leading to Participant Withdrawal From the Trial

  Day 1 to Day 85

• Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration

  Day 1 to Day 7

• Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration

  Day 1 to Day 7

• Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine

  Day 1 to Day 28

Study Arms (1)

Open Arm Study

EXPERIMENTAL

One dose given to all participants

Biological: HIL-214

Interventions

HIL-214 BIOLOGICAL

HIL-214

Open Arm Study

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HilleVax: lead

Study Sites (2)

Pennisula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Astrid Borkowski, Chief Medical Officer
• Organization: HilleVax, Inc.

aborkowski@hillevax.com

+1 (617) 213-6562

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, Open-label Trial

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: August 14, 2023
• Study Completion: November 10, 2023
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-07

Locations

US (2)