Status:
COMPLETED
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
Lead Sponsor:
HilleVax
Conditions:
Gastroenteritis
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
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.
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 assess...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05972733
Start Date
August 1 2023
End Date
November 10 2023
Last Update
August 19 2025
Active Locations (2)
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1
Pennisula Research Associates
Rolling Hills Estates, California, United States, 90274
2
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281