Trial Outcomes & Findings for Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines (NCT NCT05836012)
NCT ID: NCT05836012
Last Updated: 2025-03-12
Results Overview
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis \[FHA\], \[PRN\] and \[PTX\]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
329 participants
Primary outcome timeframe
28 days post-dose 2
Results posted on
2025-03-12
Participant Flow
Participants took part in the trial at 10 investigative sites in Panama and the United States from 10 June 2023 to 08 July 2024.
Participants were enrolled in 1 of 2 treatment arms and received 2 doses of either 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, or placebo.
Participant milestones
| Measure |
Placebo
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
165
|
|
Overall Study
COMPLETED
|
160
|
161
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Placebo
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Reason not included in pre-specified categories
|
2
|
1
|
Baseline Characteristics
Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines
Baseline characteristics by cohort
| Measure |
Placebo
n=164 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214
n=165 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
164 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
125.7 days
STANDARD_DEVIATION 4.35 • n=5 Participants
|
125.6 days
STANDARD_DEVIATION 4.48 • n=7 Participants
|
125.7 days
STANDARD_DEVIATION 4.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
159 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · More than one race
|
151 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Panama
|
150 participants
n=5 Participants
|
152 participants
n=7 Participants
|
302 participants
n=5 Participants
|
|
Prior Vaccinations
Yes
|
163 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Prior Vaccinations
No
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Breastfeeding Status
Breastfeeding
|
143 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Breastfeeding Status
Not breastfeeding
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Weight
|
7.00 kg
STANDARD_DEVIATION 0.892 • n=5 Participants
|
7.01 kg
STANDARD_DEVIATION 0.877 • n=7 Participants
|
7.00 kg
STANDARD_DEVIATION 0.883 • n=5 Participants
|
|
Length
|
61.84 cm
STANDARD_DEVIATION 2.221 • n=5 Participants
|
62.12 cm
STANDARD_DEVIATION 2.219 • n=7 Participants
|
61.98 cm
STANDARD_DEVIATION 2.221 • n=5 Participants
|
|
Head Circumference
|
41.24 cm
STANDARD_DEVIATION 1.217 • n=5 Participants
|
41.33 cm
STANDARD_DEVIATION 1.290 • n=7 Participants
|
41.29 cm
STANDARD_DEVIATION 1.253 • n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post-dose 2Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that received all doses of all study vaccines (routine and trial vaccines) within the required time window.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis \[FHA\], \[PRN\] and \[PTX\]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
Outcome measures
| Measure |
HIL-214 (Panama)
n=139 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
n=9 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
n=9 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=147 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-diphtheria toxoid IgG concentration ≥0.1 IU/mL.
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
99.3 percentage of participants
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-tetanus toxoid IgG concentration ≥0.1 IU/mL
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2
|
100 percentage of participants
|
100 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2
|
99.2 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
99.3 percentage of participants
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-HBsAg IgG concentration ≥10 mIU/mL
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-PRP IgG concentration ≥ 0.15 ug/mL
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: 28 days post-dose 2Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: Geometric mean anti-FHA, anti-PRN, and anti-PTX concentrations
Outcome measures
| Measure |
HIL-214 (Panama)
n=139 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
n=9 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
n=9 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=147 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pertussis FHA concentration
|
78.726 IU/mL
Standard Deviation 1.8566
|
32.515 IU/mL
Standard Deviation 2.9346
|
26.358 IU/mL
Standard Deviation 2.7499
|
83.958 IU/mL
Standard Deviation 1.8338
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pertussis toxin (PTX) concentration
|
48.906 IU/mL
Standard Deviation 2.0150
|
80.713 IU/mL
Standard Deviation 2.2249
|
43.066 IU/mL
Standard Deviation 2.5144
|
48.536 IU/mL
Standard Deviation 1.8552
|
|
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pertactin (PRN) concentration
|
84.617 IU/mL
Standard Deviation 2.2496
|
61.222 IU/mL
Standard Deviation 2.6526
|
43.417 IU/mL
Standard Deviation 2.7743
|
92.605 IU/mL
Standard Deviation 2.1811
|
PRIMARY outcome
Timeframe: 28 days post-dose 2Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window.
The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG \[serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F\]) at 28 days post-dose. Geometric mean concentrations are presented.
Outcome measures
| Measure |
HIL-214 (Panama)
n=143 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=154 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 1
|
5.802 ug/mL
Standard Deviation 2.2008
|
—
|
—
|
5.255 ug/mL
Standard Deviation 1.9827
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 3
|
0.747 ug/mL
Standard Deviation 2.2117
|
—
|
—
|
0.777 ug/mL
Standard Deviation 2.3728
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 4
|
2.773 ug/mL
Standard Deviation 2.0253
|
—
|
—
|
2.958 ug/mL
Standard Deviation 1.8468
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 7F
|
5.063 ug/mL
Standard Deviation 1.7727
|
—
|
—
|
5.091 ug/mL
Standard Deviation 1.6726
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 9V
|
3.568 ug/mL
Standard Deviation 2.1651
|
—
|
—
|
3.881 ug/mL
Standard Deviation 1.9259
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 14
|
12.017 ug/mL
Standard Deviation 2.3278
|
—
|
—
|
11.819 ug/mL
Standard Deviation 2.3158
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 19A
|
3.069 ug/mL
Standard Deviation 1.9742
|
—
|
—
|
3.203 ug/mL
Standard Deviation 2.0635
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 19F
|
5.487 ug/mL
Standard Deviation 2.1713
|
—
|
—
|
5.822 ug/mL
Standard Deviation 2.0030
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 18C
|
3.040 ug/mL
Standard Deviation 1.9344
|
—
|
—
|
2.997 ug/mL
Standard Deviation 1.8435
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 23F
|
2.543 ug/mL
Standard Deviation 2.7745
|
—
|
—
|
2.885 ug/mL
Standard Deviation 2.5878
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 5
|
2.429 ug/mL
Standard Deviation 1.9277
|
—
|
—
|
2.378 ug/mL
Standard Deviation 1.9223
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 6A
|
7.414 ug/mL
Standard Deviation 2.2194
|
—
|
—
|
7.660 ug/mL
Standard Deviation 2.0384
|
|
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Anti-pneumococcal IgG concentration for serotype 6B
|
5.459 ug/mL
Standard Deviation 2.7604
|
—
|
—
|
6.419 ug/mL
Standard Deviation 2.3854
|
PRIMARY outcome
Timeframe: 28 days post-dose 2Population: Immunology Evaluable Analysis Set, all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window
This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported.
Outcome measures
| Measure |
HIL-214 (Panama)
n=147 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=155 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
|
87.694 U/mL
Standard Deviation 4.2618
|
—
|
—
|
67.772 U/mL
Standard Deviation 4.0633
|
SECONDARY outcome
Timeframe: Pre-dose 1 and 28 days post-dose 2Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window.
Anti-norovirus (GI.1 and GII.4c) HBGA-blocking antibodies were measured at prior to dose 1 (\~4 months of age) and 28 days post-dose 2 (\~6 months of age). Seroresponse was defined as a fold increase from baseline greater than or equal to 4. Seroresponse rates and 95% confidence intervals (CIs) are presented. Data are stratified by country (Panama and USA).
Outcome measures
| Measure |
HIL-214 (Panama)
n=119 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
n=6 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
n=7 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=123 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.
Anti-GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2
|
51.3 percentage of participants
Interval 41.9 to 60.5
|
0 percentage of participants
Interval 0.0 to 52.5
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
1.6 percentage of participants
Interval 0.2 to 5.8
|
|
Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.
Anti-GI.1 seroresponse by HBGA-blocking assay at 28 days post-dose 2
|
97.5 percentage of participants
Interval 92.7 to 99.5
|
0 percentage of participants
Interval 0.0 to 45.9
|
100 percentage of participants
Interval 59.0 to 100.0
|
4.1 percentage of participants
Interval 1.3 to 9.2
|
|
Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.
Anti-GI.1 and GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2
|
53.0 percentage of participants
Interval 43.5 to 62.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0.8 percentage of participants
Interval 0.0 to 4.5
|
SECONDARY outcome
Timeframe: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2Population: Safety Analysis Set, all participants that received trial vaccine (HIL-214 or placebo)
Percentage of participants with solicited local (injection site) reactions within 7 days of any vaccine administration. Assessed reactions included pain, redness, induration, and swelling.
Outcome measures
| Measure |
HIL-214 (Panama)
n=165 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=164 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
|
41.2 percentage of participants
|
—
|
—
|
38.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2Population: Safety Analysis Set; all participants that received trial vaccine (HIL 214 or placebo).
Percentage of participants with solicited systemic adverse events (AEs) within 7 days of any vaccine administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Outcome measures
| Measure |
HIL-214 (Panama)
n=165 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=164 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
|
46.1 percentage of participants
|
—
|
—
|
54.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to 28 days post-dose 1 (vaccine discontinuation); Day 1 to 12 months post-dose 1Population: Safety Analysis Set; all participants that received trial vaccine (HIL-214 or placebo).
Percentage of participants with adverse events (AEs) leading to vaccine discontinuation or trial withdrawal.
Outcome measures
| Measure |
HIL-214 (Panama)
n=165 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=164 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
AE leading to vaccine discontinuation
|
0 percentage of participants
|
—
|
—
|
0 percentage of participants
|
|
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
AE leading to trial withdrawal
|
0 percentage of participants
|
—
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to 12 months post-dose 1Population: Safety Analysis Set; all participants that received trial vaccine (HIL-214 or placebo)
Percentage of participants with medically attended adverse events (AEs) at any point during the trial.
Outcome measures
| Measure |
HIL-214 (Panama)
n=165 Participants
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo (USA)
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
HIL-214 (USA)
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule.
|
Placebo
n=164 Participants
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule.
|
|---|---|---|---|---|
|
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo
|
65.5 percentage of participants
|
—
|
—
|
63.4 percentage of participants
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 81 other events
Deaths: 0 deaths
HIL-214
Serious events: 3 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=164 participants at risk
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age), and routine childhood vaccines according to schedule.
|
HIL-214
n=165 participants at risk
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age), and routine childhood vaccines according to schedule.
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
1.8%
3/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
0.61%
1/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
|
Infections and infestations
Pneumonia
|
0.61%
1/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
0.61%
1/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
|
Infections and infestations
Pneumonia respiratory syncytial virus
|
1.2%
2/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
0.00%
0/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
0.00%
0/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
0.61%
1/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
Other adverse events
| Measure |
Placebo
n=164 participants at risk
1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age), and routine childhood vaccines according to schedule.
|
HIL-214
n=165 participants at risk
1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age), and routine childhood vaccines according to schedule.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
39.0%
64/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
33.3%
55/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
|
Infections and infestations
Gastroenteritis
|
3.0%
5/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
6.1%
10/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
|
Infections and infestations
Bronchiolitis
|
2.4%
4/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
4.8%
8/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
|
General disorders
Pyrexia
|
4.9%
8/164 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
2.4%
4/165 • Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.
|
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