Gastroenteritis
Conditions
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).
Interventions
BIOLOGICALHIL-214
HIL-214
Sponsors
HilleVax
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-arm, Open-label Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the trial at 2 investigative sites in the United States from 01 August 2023 to 10 November 2023.
Pre-assignment details
Healthy volunteers were enrolled in 1 treatment arm and received a single dose of HIL-214, a norovirus vaccine comprising 50 µg GI.1 virus-like particle (VLP) and 150 µg GII.4c VLP, adjuvanted with 500 µg of aluminum hydroxide.
Participants by arm
| Arm | Count |
|---|---|
| HIL-214 One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HIL-214 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age, Continuous | 35.2 years STANDARD_DEVIATION 9.21 |
| Body Mass Index | 30.06 kg/m^2 STANDARD_DEVIATION 8.358 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 170.70 cm STANDARD_DEVIATION 10.822 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 32 Participants |
| Weight | 87.32 kg STANDARD_DEVIATION 24.573 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 52 / 79 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
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
Population: Safety Analysis Set, all participants that received trial vaccine (HIL-214).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIL-214 | Primary Immunogenicity for Panel Formation | Anti-GI.1 HBGA-blocking seroresponse rate | 87.0 Percentage of Participants |
| HIL-214 | Primary Immunogenicity for Panel Formation | Anti-GII.4c HBGA-blocking seroresponse rate | 72.7 Percentage of Participants |
| HIL-214 | Primary Immunogenicity for Panel Formation | Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate | 60.5 Percentage of Participants |
| HIL-214 | Primary Immunogenicity for Panel Formation | Anti-GI.1 pan-Ig seroresponse rate | 98.7 Percentage of Participants |
| HIL-214 | Primary Immunogenicity for Panel Formation | Anti-GII.4c pan-Ig seroresponse rate | 91.0 Percentage of Participants |
| HIL-214 | Primary Immunogenicity for Panel Formation | Anti-GI.1 and GII.4c pan-Ig seroresponse rate | 91.0 Percentage of Participants |
Secondary
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
Population: Safety Analysis Set, all participants that received trial vaccine (HIL-214).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIL-214 | Adverse Events Leading to Participant Withdrawal From the Trial | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIL-214 | Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine | 7 Participants |
Secondary
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
Population: Safety Analysis Set, all participants who received trial vaccine (HIL-214).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIL-214 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration | 48.1 percentage of participants |
Secondary
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
Population: Safety Analysis Set, all participants who received trial vaccine (HIL-214).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIL-214 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration | 55.7 percentage of participants |