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 range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.