Trial Outcomes & Findings for Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults (NCT NCT05972733)
NCT ID: NCT05972733
Last Updated: 2025-08-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Day 1 to Day 29
Results posted on
2025-08-19
Participant Flow
Participants took part in the trial at 2 investigative sites in the United States from 01 August 2023 to 10 November 2023.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
77
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
Baseline characteristics by cohort
| Measure |
HIL-214
n=80 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 9.21 • n=99 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=99 Participants
|
|
Weight
|
87.32 kg
STANDARD_DEVIATION 24.573 • n=99 Participants
|
|
Height
|
170.70 cm
STANDARD_DEVIATION 10.822 • n=99 Participants
|
|
Body Mass Index
|
30.06 kg/m^2
STANDARD_DEVIATION 8.358 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: Safety Analysis Set, all participants that received trial vaccine (HIL-214).
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.
Outcome measures
| Measure |
HIL-214
n=78 Participants
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.
|
|---|---|
|
Primary Immunogenicity for Panel Formation
Anti-GI.1 HBGA-blocking seroresponse rate
|
87.0 Percentage of Participants
Interval 77.4 to 93.6
|
|
Primary Immunogenicity for Panel Formation
Anti-GII.4c HBGA-blocking seroresponse rate
|
72.7 Percentage of Participants
Interval 61.4 to 82.3
|
|
Primary Immunogenicity for Panel Formation
Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate
|
60.5 Percentage of Participants
Interval 48.6 to 71.6
|
|
Primary Immunogenicity for Panel Formation
Anti-GI.1 pan-Ig seroresponse rate
|
98.7 Percentage of Participants
Interval 93.1 to 100.0
|
|
Primary Immunogenicity for Panel Formation
Anti-GII.4c pan-Ig seroresponse rate
|
91.0 Percentage of Participants
Interval 82.4 to 96.3
|
|
Primary Immunogenicity for Panel Formation
Anti-GI.1 and GII.4c pan-Ig seroresponse rate
|
91.0 Percentage of Participants
Interval 82.4 to 96.3
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: Safety Analysis Set, all participants that received trial vaccine (HIL-214).
Adverse events leading to trial withdrawal were collected throughout the trial.
Outcome measures
| Measure |
HIL-214
n=80 Participants
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.
|
|---|---|
|
Adverse Events Leading to Participant Withdrawal From the Trial
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Safety Analysis Set, all participants who received trial vaccine (HIL-214).
Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.
Outcome measures
| Measure |
HIL-214
n=79 Participants
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.
|
|---|---|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration
|
48.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Safety Analysis Set, all participants who received trial vaccine (HIL-214).
Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Outcome measures
| Measure |
HIL-214
n=79 Participants
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.
|
|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration
|
55.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.
Outcome measures
| Measure |
HIL-214
n=80 Participants
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.
|
|---|---|
|
Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine
|
7 Participants
|
Adverse Events
HIL-214
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIL-214
n=79 participants at risk；n=80 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Injection site pain
|
44.3%
35/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
Injury, poisoning and procedural complications
Redness
|
7.6%
6/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
Injury, poisoning and procedural complications
Swelling
|
5.1%
4/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
Injury, poisoning and procedural complications
Induration
|
8.9%
7/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
General disorders
Headache
|
30.4%
24/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
General disorders
Fatigue
|
34.2%
27/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
General disorders
Myalgia
|
39.2%
31/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
General disorders
Arthralgia
|
13.9%
11/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
General disorders
Vomiting
|
5.1%
4/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
|
General disorders
Diarrhea
|
8.9%
7/79 • Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85
Solicited AE (local and systemic) data was collected for 79 participants.
|
Additional Information
Astrid Borkowski, Chief Medical Officer
HilleVax, Inc.
Phone: +1 (617) 213-6562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place