Phase 2
Completed N=80
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
Source: ClinicalTrials.gov NCT05972733 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Primary Immunogenicity for Panel Formation — 87.0; 72.7; 60.5; 98.7 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Immunogenicity for Panel Formation |
87.0; 72.7; 60.5; 98.7; 91.0; 91.0 | — |
| SECONDARY Adverse Events Leading to Participant Withdrawal From the Trial |
— | — |
| SECONDARY Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration |
48.1 | — |
| SECONDARY Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration |
55.7 | — |
| SECONDARY Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine |
7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05972733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.