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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
80
HIL-214
Pennisula Research Associates
Rolling Hills Estates, California, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Primary Immunogenicity for Panel Formation
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.
Time frame: Day 1 to Day 29
Adverse Events Leading to Participant Withdrawal From the Trial
Adverse events leading to trial withdrawal were collected throughout the trial.
Time frame: Day 1 to Day 85
Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration
Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.
Time frame: Day 1 to Day 7
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration
Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Time frame: Day 1 to Day 7
Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine
Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.
Time frame: Day 1 to Day 28
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