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

Phase 2

Completed

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 assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Open Arm Study	HIL-214	One dose given to all participants

Primary Outcome Measures

Name	Time	Method
Primary Immunogenicity for Panel Formation	Day 1 to Day 29	Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.

Secondary Outcome Measures

Name	Time	Method
Adverse Events Leading to Participant Withdrawal From the Trial	Day 1 to Day 85	Adverse events leading to trial withdrawal were collected throughout the trial.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration	Day 1 to Day 7	Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration	Day 1 to Day 7	Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine	Day 1 to Day 28	Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.

Locations (2): Pennisula Research Associates
🇺🇸
Rolling Hills Estates, California, United States
Clinical Research Atlanta
🇺🇸
Stockbridge, Georgia, United States
Pennisula Research Associates
🇺🇸Rolling Hills Estates, California, United States