Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults (NCT05972733) | Clinical Trial Compass
CompletedPhase 2
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
United States80 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range18 Years ā 49 Years
SexALL
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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.