NCT05972733

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: HilleVax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	HIL-214	HIL-214

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-08-14
• Completion: 2023-11-10
• First posted: 2023-08-02
• Last updated: 2025-08-19
• Results posted: 2025-08-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study