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

Completed · Phase 2

Conditions studied: Gastroenteritis

In brief

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.

Key facts

Study ID

NCT05972733

Run by

HilleVax

People needed

80

Starts

2023-08-01

Expected to finish

2023-11-10

Last updated by the study team

2025-08-19

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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