Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine (NCT NCT04349553)
NCT ID: NCT04349553
Last Updated: 2025-08-17
Results Overview
Number of adverse events as assessed by adverse events, laboratory safety tests (biochemistry, haematology, urinalysis), vital signs and physical examination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
From Day 0 to Day 84
Results posted on
2025-08-17
Participant Flow
Forty-six (46) subjects (45 and 1 replacement) were enrolled into the study and dosed. The study started (first visit) on 16 December 2019 and recruitment was completed by 19 June 2020.
Participant milestones
| Measure |
ZH9PA 1x10^9 CFU
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
12
|
12
|
15
|
|
Overall Study
COMPLETED
|
6
|
12
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
ZH9PA 1x10^9 CFU
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine
Baseline characteristics by cohort
| Measure |
ZH9PA 1x10^9 CFU
n=7 Participants
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo: 150mL vaccine for oral administration
ZH9PA: 150mL vaccine for oral administration
|
ZH9PA 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo: 150mL vaccine for oral administration
ZH9PA: 150mL vaccine for oral administration
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9: 150mL vaccine for oral administration
Placebo: 150mL vaccine for oral administration
|
Placebo
n=15 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9: 150mL vaccine for oral administration
Placebo: 150mL vaccine for oral administration
ZH9PA: 150mL vaccine for oral administration
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 3.69 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 7.87 • n=7 Participants
|
34.4 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 5.52 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 6.12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
28 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
44 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 84Number of adverse events as assessed by adverse events, laboratory safety tests (biochemistry, haematology, urinalysis), vital signs and physical examination.
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
n=7 Participants
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=15 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
4 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 84Tests include blood pressure, heart rate, physical examination, laboratory biochemistry, haematology and urinalysis tests
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
n=7 Participants
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=15 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 85 to Day 224Incidence of Serious adverse events
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
n=7 Participants
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=15 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 85 to Day 224Tests include blood pressure, heart rate, physical examination, laboratory biochemistry, haematology and urinalysis tests if these assessments are undertaken for cause.
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
n=7 Participants
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=15 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 21, Day 42, and Day 84Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen H:a
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
n=6 Participants
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=11 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=15 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:a
Day 21
|
0.984 Fold-Increase
Interval 0.594 to 1.375
|
1.470 Fold-Increase
Interval 1.194 to 1.746
|
1.106 Fold-Increase
Interval 0.817 to 1.394
|
1.055 Fold-Increase
Interval 0.808 to 1.302
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:a
Day 42
|
1.346 Fold-Increase
Interval -1.721 to 4.414
|
4.522 Fold-Increase
Interval 2.353 to 6.691
|
1.349 Fold-Increase
Interval -0.917 to 3.614
|
1.119 Fold-Increase
Interval -0.822 to 3.059
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:a
Day 84
|
1.643 Fold-Increase
Interval -0.812 to 4.098
|
4.968 Fold-Increase
Interval 3.232 to 6.704
|
2.417 Fold-Increase
Interval 0.604 to 4.23
|
1.372 Fold-Increase
Interval -0.181 to 2.925
|
SECONDARY outcome
Timeframe: Day 0, Day 21, Day 42, and Day 84Population: The two groups did not receive the vaccine with antibodies to the antigen H:d (ZH9) so is not measured at Day 21, Day 42 or Day 84
Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen H:d
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=11 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=12 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:d
Day 21
|
—
|
—
|
8.068 Fold-Increase
Interval 6.76 to 9.376
|
0.878 Fold-Increase
Interval -0.374 to 2.13
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:d
Day 42
|
—
|
—
|
6.783 Fold-Increase
Interval 5.731 to 7.836
|
0.838 Fold-Increase
Interval -0.17 to 1.846
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:d
Day 84
|
—
|
—
|
5.819 Fold-Increase
Interval 4.693 to 6.946
|
0.875 Fold-Increase
Interval -0.204 to 1.953
|
SECONDARY outcome
Timeframe: Day 0, Day 21, Day 42, and Day 84Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen LPSO:2
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
n=6 Participants
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
n=12 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=11 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=15 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:2
Day 21
|
2.489 Fold-Increase
Interval -5.27 to 10.248
|
4.466 Fold-Increase
Interval -1.02 to 9.953
|
15.858 Fold-Increase
Interval 10.127 to 21.589
|
0.964 Fold-Increase
Interval -3.943 to 5.872
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:2
Day 42
|
3.061 Fold-Increase
Interval -0.658 to 6.78
|
3.305 Fold-Increase
Interval 0.675 to 5.935
|
8.877 Fold-Increase
Interval 6.13 to 11.624
|
0.939 Fold-Increase
Interval -1.413 to 3.292
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:2
Day 84
|
2.621 Fold-Increase
Interval 1.157 to 4.085
|
2.759 Fold-Increase
Interval 1.723 to 3.794
|
4.386 Fold-Increase
Interval 3.305 to 5.468
|
1.024 Fold-Increase
Interval 0.098 to 1.95
|
SECONDARY outcome
Timeframe: Day 0, Day 21, Day 42, and Day 84Population: The two groups did not receive the vaccine with antibodies to the antigen LPSO:9 (ZH9) so is not measured at Day 21, Day 42 or Day 84.
Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen LPSO:9
Outcome measures
| Measure |
ZH9PA 1x10^9 CFU
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=11 Participants
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
Placebo
n=12 Participants
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo 150mL vaccine for oral administration: Each subject received 3 doses of vaccine on Day 0, Day 21 and Day 42
|
|---|---|---|---|---|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:9
Day 21
|
—
|
—
|
19.292 Fold-Increase
Interval 5.265 to 33.32
|
1.005 Fold-Increase
Interval -12.425 to 14.436
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:9
Day 42
|
—
|
—
|
11.103 Fold-Increase
Interval 4.275 to 17.931
|
0.845 Fold-Increase
Interval -5.692 to 7.383
|
|
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:9
Day 84
|
—
|
—
|
9.686 Fold-Increase
Interval 3.074 to 16.297
|
0.998 Fold-Increase
Interval -5.332 to 7.328
|
Adverse Events
ZH9PA 1x10^9 CFU
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ZH9PA 1x10^10 CFU
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ZH9PA 1x10^9 CFU
n=7 participants at risk
1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo: 150mL vaccine for oral administration
ZH9PA: 150mL vaccine for oral administration
|
ZH9PA 1x10^10 CFU
n=12 participants at risk
1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
Placebo: 150mL vaccine for oral administration
ZH9PA: 150mL vaccine for oral administration
|
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU
n=12 participants at risk
1mL ZH9PA 1x10\^10 CFU suspension in normal saline and 1mL ZH9 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9: 150mL vaccine for oral administration
Placebo: 150mL vaccine for oral administration
|
Placebo
n=15 participants at risk
1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration
ZH9PA and ZH9: 150mL vaccine for oral administration
Placebo: 150mL vaccine for oral administration
ZH9PA: 150mL vaccine for oral administration
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|---|---|---|---|---|
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Nervous system disorders
Headache
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
33.3%
4/12 • Number of events 4 • Up to 12 weeks post-dose (Day 84)
|
25.0%
3/12 • Number of events 7 • Up to 12 weeks post-dose (Day 84)
|
26.7%
4/15 • Number of events 5 • Up to 12 weeks post-dose (Day 84)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
16.7%
2/12 • Number of events 2 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
13.3%
2/15 • Number of events 2 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
16.7%
2/12 • Number of events 2 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
16.7%
2/12 • Number of events 5 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 2 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 3 • Up to 12 weeks post-dose (Day 84)
|
6.7%
1/15 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
6.7%
1/15 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
6.7%
1/15 • Number of events 2 • Up to 12 weeks post-dose (Day 84)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
6.7%
1/15 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
6.7%
1/15 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
8.3%
1/12 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
6.7%
1/15 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
|
Nervous system disorders
Taste disorder
|
14.3%
1/7 • Number of events 1 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/12 • Up to 12 weeks post-dose (Day 84)
|
0.00%
0/15 • Up to 12 weeks post-dose (Day 84)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place