Trial Outcomes & Findings for Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines (NCT NCT04875676)
NCT ID: NCT04875676
Last Updated: 2024-05-22
Results Overview
Comparison of VPI specific immunoglobin A (IgA) ASC levels between the 3 study cohorts by enzyme-linked immunospot (ELISpot) assay
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Day 1 (Initial Vaccination) through Day 8 post boost (Second Vaccination)
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
Cohort 1 (4-week Boost Vaccination)
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (4-week Boost Vaccination)
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines
Baseline characteristics by cohort
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 9.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Height
|
163.23 centimeter
STANDARD_DEVIATION 7.236 • n=5 Participants
|
175.63 centimeter
STANDARD_DEVIATION 7.850 • n=7 Participants
|
166.22 centimeter
STANDARD_DEVIATION 10.734 • n=5 Participants
|
168.36 centimeter
STANDARD_DEVIATION 10.001 • n=4 Participants
|
|
Weight
|
75.22 kilogram
STANDARD_DEVIATION 9.359 • n=5 Participants
|
86.99 kilogram
STANDARD_DEVIATION 20.457 • n=7 Participants
|
75.54 kilogram
STANDARD_DEVIATION 13.360 • n=5 Participants
|
79.25 kilogram
STANDARD_DEVIATION 15.603 • n=4 Participants
|
|
BMI
|
28.27 kg/m^2
STANDARD_DEVIATION 3.248 • n=5 Participants
|
27.94 kg/m^2
STANDARD_DEVIATION 4.940 • n=7 Participants
|
27.32 kg/m^2
STANDARD_DEVIATION 3.917 • n=5 Participants
|
27.84 kg/m^2
STANDARD_DEVIATION 3.971 • n=4 Participants
|
|
Vaccinated for COVID-19
Yes - Pfizer-BioNTech
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Vaccinated for COVID-19
Yes - Moderna
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Vaccinated for COVID-19
Yes - Johnson & Johnson
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Vaccinated for COVID-19
Yes - Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Vaccinated for COVID-19
No
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Initial Vaccination) through Day 8 post boost (Second Vaccination)Population: 1 subject received 1 dose only (8-week boost cohort)
Comparison of VPI specific immunoglobin A (IgA) ASC levels between the 3 study cohorts by enzyme-linked immunospot (ELISpot) assay
Outcome measures
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay
First Dose
|
1.3 Spot Forming Units per 10^6 PBMC
Interval -0.4 to 3.0
|
0.5 Spot Forming Units per 10^6 PBMC
Interval -0.4 to 1.3
|
0.3 Spot Forming Units per 10^6 PBMC
Interval -0.2 to 0.8
|
|
Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay
7-Days post First Dose
|
127.6 Spot Forming Units per 10^6 PBMC
Interval 23.8 to 231.4
|
214.3 Spot Forming Units per 10^6 PBMC
Interval 15.8 to 412.9
|
327.5 Spot Forming Units per 10^6 PBMC
Interval -106.4 to 761.4
|
|
Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay
Second Dose
|
2 Spot Forming Units per 10^6 PBMC
Interval 0.1 to 4.0
|
2.1 Spot Forming Units per 10^6 PBMC
Interval -1.1 to 5.2
|
2.3 Spot Forming Units per 10^6 PBMC
Interval -0.3 to 4.8
|
|
Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay
7-Days post Second Dose
|
25.5 Spot Forming Units per 10^6 PBMC
Interval -6.2 to 57.2
|
68.8 Spot Forming Units per 10^6 PBMC
Interval -29.4 to 167.0
|
132.1 Spot Forming Units per 10^6 PBMC
Interval -16.1 to 280.4
|
PRIMARY outcome
Timeframe: Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)Population: 1 subject received 1 dose only (8-week boost cohort)
Comparison of subjects with a ≥2-, 3- or 4-fold increase over baseline titer of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts.
Outcome measures
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay
Day of First Dose: GMC (geometric mean concentration)
|
29.9 10^6 AU/mL
Interval 17.0 to 52.6
|
27.9 10^6 AU/mL
Interval 12.8 to 60.9
|
21.1 10^6 AU/mL
Interval 12.0 to 37.1
|
|
Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay
28-Days post First Dose: GMC (geometric mean concentration)
|
52.7 10^6 AU/mL
Interval 28.8 to 96.2
|
69.5 10^6 AU/mL
Interval 23.2 to 208.4
|
54.9 10^6 AU/mL
Interval 18.7 to 161.2
|
|
Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay
28-Days post Second Dose: GMC (geometric mean concentration)
|
74.5 10^6 AU/mL
Interval 36.9 to 150.4
|
54.0 10^6 AU/mL
Interval 19.0 to 153.8
|
64.9 10^6 AU/mL
Interval 24.4 to 172.8
|
PRIMARY outcome
Timeframe: Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)Population: 1 subject received 1 dose only (8-week boost cohort)
Comparison of VPI specific immunoglobin A (IgA) ASC levels by Mesoscale Discovery (MSD) assay between the 3 study cohorts
Outcome measures
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay
First Dose: GMC (geometric mean concentration)
|
0.5 10^6 AU/mL
Interval 0.1 to 2.1
|
0.3 10^6 AU/mL
Interval 0.1 to 1.2
|
0.2 10^6 AU/mL
Interval 0.0 to 1.1
|
|
VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay
28-Days post the First Dose: GMC (geometric mean concentration)
|
2.1 10^6 AU/mL
Interval 0.9 to 4.9
|
2.6 10^6 AU/mL
Interval 0.8 to 8.7
|
2.1 10^6 AU/mL
Interval 0.4 to 11.2
|
|
VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay
28-Days post the Second Dose: GMC (geometric mean concentration)
|
1.5 10^6 AU/mL
Interval 0.6 to 3.9
|
1.2 10^6 AU/mL
Interval 0.4 to 3.6
|
1.7 10^6 AU/mL
Interval 0.5 to 6.1
|
PRIMARY outcome
Timeframe: Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)Population: 1 subject received 1 dose only (8-week boost cohort)
Comparison of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts
Outcome measures
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay
28-Days post First Dose: GMFR (geometric mean fold rise)
|
1.8 Fold Rise
Interval 1.2 to 2.7
|
2.5 Fold Rise
Interval 1.2 to 5.4
|
2.6 Fold Rise
Interval 1.3 to 5.1
|
|
Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay
28-Days post Second Dose: GMFR (geometric mean fold rise)
|
2.5 Fold Rise
Interval 1.5 to 4.1
|
2.4 Fold Rise
Interval 1.3 to 4.3
|
3.1 Fold Rise
Interval 1.8 to 5.1
|
PRIMARY outcome
Timeframe: Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)Population: 1 subject received 1 dose only (8-week boost cohort)
Comparison of VPI specific immunoglobin A (IgA) ASC levels by Mesoscale Discovery (MSD) assay between the 3 study cohorts
Outcome measures
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay
28-Days post the First Dose: GMFR (geometric mean fold rise)
|
4.6 Fold rise
Interval 1.6 to 13.6
|
8.9 Fold rise
Interval 3.9 to 20.5
|
11.3 Fold rise
Interval 3.4 to 37.0
|
|
VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay
28-Days post the Second Dose: GMFR (geometric mean fold rise)
|
3.3 Fold rise
Interval 1.3 to 8.5
|
5.4 Fold rise
Interval 2.5 to 11.7
|
8.9 Fold rise
Interval 2.9 to 26.8
|
SECONDARY outcome
Timeframe: Day 1 (Vaccination) to Day 8 post each vaccinationPopulation: Subjects with Solicited Symptoms
Comparison of frequency, duration, and severity of solicited symptom events in participants
Outcome measures
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Solicited Symptoms of Reactogenicity
Myalgia: Mild
|
2 events
|
0 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Vomiting: Moderate
|
0 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Fever: Total
|
0 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Fever: Mild
|
0 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Fever: Moderate
|
0 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Headache: Total
|
5 events
|
1 events
|
5 events
|
|
Solicited Symptoms of Reactogenicity
Headache: Mild
|
4 events
|
1 events
|
3 events
|
|
Solicited Symptoms of Reactogenicity
Headache: Moderate
|
1 events
|
0 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Myalgia: Total
|
2 events
|
1 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Myalgi: Moderate
|
0 events
|
1 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Abdominal Pain: Total
|
2 events
|
2 events
|
3 events
|
|
Solicited Symptoms of Reactogenicity
Abdominal Pain: Mild
|
2 events
|
1 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Abdominal Pain: Moderate
|
0 events
|
1 events
|
1 events
|
|
Solicited Symptoms of Reactogenicity
Anorexia: Total
|
1 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Anorexia: Mild
|
1 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Anorexia: Moderate
|
0 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Nausea: Total
|
1 events
|
0 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Nausea: Mild
|
1 events
|
0 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Nausea: Moderate
|
0 events
|
0 events
|
0 events
|
|
Solicited Symptoms of Reactogenicity
Vomiting: Total
|
1 events
|
0 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Vomiting: Mild
|
1 events
|
0 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Diarrhea: Total
|
3 events
|
2 events
|
4 events
|
|
Solicited Symptoms of Reactogenicity
Diarrhea: Mild
|
2 events
|
1 events
|
3 events
|
|
Solicited Symptoms of Reactogenicity
Diarrhea: Moderate
|
1 events
|
1 events
|
1 events
|
|
Solicited Symptoms of Reactogenicity
Malaise/Fatigue: Total
|
3 events
|
1 events
|
3 events
|
|
Solicited Symptoms of Reactogenicity
Malaise/Fatigue: Mild
|
2 events
|
1 events
|
2 events
|
|
Solicited Symptoms of Reactogenicity
Malaise/Fatigue: Moderate
|
1 events
|
0 events
|
1 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Vaccine) through 28 days following boost (Second Vaccination)Population: Subjects with Any Unsolicited AEs
Comparison of the frequency, duration, and severity of unsolicited AEs and serious AEs (SAEs) including AEs of Special Interest (AESIs) and new onsets of chronic illness (NOCIs) in participants
Outcome measures
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 Participants
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 Participants
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 Participants
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Unsolicited Adverse Events (AEs)
Syncope (Mild)
|
1 events
|
0 events
|
1 events
|
|
Unsolicited Adverse Events (AEs)
Toothache (Mild)
|
0 events
|
0 events
|
1 events
|
|
Unsolicited Adverse Events (AEs)
COVID-19 Pneumonia (Severe)
|
0 events
|
1 events
|
0 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Vaccine) through 6 months following boost (Second Vaccination)Frequency, duration, and severity of all SAEs, AESIs and NOCIs through 6 months after last vaccination.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (4-week Boost Vaccination)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 (8-week Boost Vaccination)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 (12-week Boost Vaccination)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 participants at risk
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 participants at risk
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 participants at risk
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
Infections and infestations
COVID-19 Pneumonia
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Investigations
Hospitalization
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
Other adverse events
| Measure |
Cohort 1 (4-week Boost Vaccination)
n=10 participants at risk
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 2 (8-week Boost Vaccination)
n=10 participants at risk
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
Cohort 3 (12-week Boost Vaccination)
n=10 participants at risk
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
VXA-G1.1-NN: Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Number of events 5 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
50.0%
5/10 • Number of events 5 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 2 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
20.0%
2/10 • Number of events 2 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
2/10 • Number of events 2 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
20.0%
2/10 • Number of events 2 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
30.0%
3/10 • Number of events 3 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
20.0%
2/10 • Number of events 2 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
20.0%
2/10 • Number of events 2 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • Number of events 3 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
20.0%
2/10 • Number of events 2 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
40.0%
4/10 • Number of events 4 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 3 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
30.0%
3/10 • Number of events 3 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
0.00%
0/10 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
10.0%
1/10 • Number of events 1 • 6 months following boost dose
AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place