Trial Outcomes & Findings for Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults (NCT NCT01509846)
NCT ID: NCT01509846
Last Updated: 2021-08-11
Results Overview
Local and systemic reactogenicity was assessed post-vaccination using targeted physical examinations, vital signs and clinical laboratory tests, and diary cards (completed following discharge daily through Day 7). Reactogenicity included: nausea, vomiting, fever, abdominal pain, abdominal cramping, bloating, malaise, headache, decreased appetite, generalized myalgias, chills, light-headedness, constipation, excessive flatulence, reactive arthritis, dysentery, loose stool, diarrhea, hypovolemia, joint pain, defecation urgency, and oral temperature.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
7 days after each vaccination (Day 0, Day 35, Day 63)
Results posted on
2021-08-11
Participant Flow
Participant milestones
| Measure |
Cohort 1
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Cohort 2
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Received Vaccination 1
STARTED
|
5
|
20
|
20
|
20
|
17
|
|
Received Vaccination 1
COMPLETED
|
5
|
20
|
20
|
20
|
17
|
|
Received Vaccination 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Received Vaccination 2
STARTED
|
5
|
20
|
20
|
20
|
17
|
|
Received Vaccination 2
COMPLETED
|
0
|
20
|
19
|
20
|
14
|
|
Received Vaccination 2
NOT COMPLETED
|
5
|
0
|
1
|
0
|
3
|
|
Received Vaccination 3
STARTED
|
0
|
20
|
19
|
20
|
14
|
|
Received Vaccination 3
COMPLETED
|
0
|
19
|
18
|
19
|
14
|
|
Received Vaccination 3
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Cohort 2
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Received Vaccination 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Received Vaccination 2
Illness
|
0
|
0
|
0
|
0
|
1
|
|
Received Vaccination 2
Not vaccinated per protocol
|
5
|
0
|
0
|
0
|
2
|
|
Received Vaccination 3
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Received Vaccination 3
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
|
Received Vaccination 3
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
Baseline characteristics by cohort
| Measure |
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
n=21 Participants
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Placebo
n=17 Participants
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
29 years
n=99 Participants
|
31.7 years
n=107 Participants
|
35.6 years
n=206 Participants
|
32.3 years
n=7 Participants
|
31.3 years
n=31 Participants
|
32.6 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
59 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
79 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
73 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 7 days after each vaccination (Day 0, Day 35, Day 63)Population: Number may differ from overall number of participants analyzed if vaccination was not received.
Local and systemic reactogenicity was assessed post-vaccination using targeted physical examinations, vital signs and clinical laboratory tests, and diary cards (completed following discharge daily through Day 7). Reactogenicity included: nausea, vomiting, fever, abdominal pain, abdominal cramping, bloating, malaise, headache, decreased appetite, generalized myalgias, chills, light-headedness, constipation, excessive flatulence, reactive arthritis, dysentery, loose stool, diarrhea, hypovolemia, joint pain, defecation urgency, and oral temperature.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 1 · None
|
12 Participants
|
9 Participants
|
11 Participants
|
5 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 1 · Mild
|
6 Participants
|
10 Participants
|
7 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 1 · Moderate
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 1 · Severe
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 2 · None
|
17 Participants
|
17 Participants
|
11 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 2 · Mild
|
1 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 2 · Moderate
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 2 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 3 · None
|
18 Participants
|
16 Participants
|
15 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 3 · Mild
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 3 · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Maximum Reactogenicity Per Subject and Treatment Group
After vaccination 3 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 months after final vaccination (Day 168 or Day 224)Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
n=17 Participants
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Frequency of Unsolicited Adverse Events With a Reasonable Possibility That the Study Product Caused the Event
Moderate
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
|
Frequency of Unsolicited Adverse Events With a Reasonable Possibility That the Study Product Caused the Event
Mild
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
|
Frequency of Unsolicited Adverse Events With a Reasonable Possibility That the Study Product Caused the Event
Severe
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Frequency of Unsolicited Adverse Events With a Reasonable Possibility That the Study Product Caused the Event
Total
|
0 adverse events
|
1 adverse events
|
2 adverse events
|
1 adverse events
|
3 adverse events
|
SECONDARY outcome
Timeframe: 35 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
3 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
17 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
17 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
17 Participants
|
—
|
—
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
13 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
7 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
3 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
17 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
9 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
11 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · Yes
|
4 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · No
|
16 Participants
|
—
|
—
|
4 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
10 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
10 Participants
|
—
|
—
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 35 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 3
Baseline
|
23 titer
Interval 16.0 to 35.0
|
—
|
—
|
27 titer
Interval 20.0 to 36.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 3
Day 7
|
34 titer
Interval 22.0 to 55.0
|
—
|
—
|
31 titer
Interval 21.0 to 45.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 3
Pre-vaccination 2 (Day 28)
|
28 titer
Interval 18.0 to 43.0
|
—
|
—
|
27 titer
Interval 18.0 to 41.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 3
Day 35
|
29 titer
Interval 19.0 to 47.0
|
—
|
—
|
26 titer
Interval 14.0 to 46.0
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4
Baseline
|
240 titer
Interval 89.0 to 647.0
|
—
|
—
|
240 titer
Interval 89.0 to 647.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4
Day 7
|
757 titer
Interval 519.0 to 1105.0
|
—
|
—
|
221 titer
Interval 62.0 to 784.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4
Pre-vaccination 2 (Day 28)
|
345 titer
Interval 215.0 to 553.0
|
—
|
—
|
213 titer
Interval 79.0 to 576.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4
Day 35
|
560 titer
Interval 368.0 to 851.0
|
—
|
—
|
281 titer
Interval 76.0 to 1038.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4
Pre-vaccination 3 (Day 56)
|
376 titer
Interval 230.0 to 613.0
|
—
|
—
|
278 titer
Interval 72.0 to 1065.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4
Day 63
|
479 titer
Interval 315.0 to 727.0
|
—
|
—
|
252 titer
Interval 68.0 to 932.0
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 7 · Yes
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 7 · No
|
20 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
3 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
16 Participants
|
—
|
—
|
4 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 35 · Yes
|
2 Participants
|
—
|
—
|
3 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 35 · No
|
17 Participants
|
—
|
—
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 7 · Yes
|
7 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 7 · No
|
13 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
7 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
13 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 35 · Yes
|
9 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 35 · No
|
11 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 3 (Day 56) · Yes
|
7 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 3 (Day 56) · No
|
12 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 63 · Yes
|
9 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 63 · No
|
11 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Week 16 · Yes
|
11 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Week 16 · No
|
9 Participants
|
—
|
—
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 35 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 3
Baseline
|
1388 titer
Interval 777.0 to 2482.0
|
—
|
—
|
1156 titer
Interval 255.0 to 5246.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 3
Day 7
|
1646 titer
Interval 955.0 to 2837.0
|
—
|
—
|
1388 titer
Interval 299.0 to 6450.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 3
Pre-vaccination 2 (Day 28)
|
1464 titer
Interval 870.0 to 2464.0
|
—
|
—
|
1593 titer
Interval 365.0 to 6958.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 3
Day 35
|
1790 titer
Interval 1056.0 to 3033.0
|
—
|
—
|
1994 titer
Interval 391.0 to 10155.0
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Results were included for subjects that received each vaccination and with usable samples.
S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Day 35
|
2997 titer
Interval 2099.0 to 4278.0
|
—
|
—
|
2498 titer
Interval 847.0 to 7368.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Pre-vaccination 3 (Day 56)
|
2884 titer
Interval 1971.0 to 4218.0
|
—
|
—
|
2635 titer
Interval 781.0 to 8894.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Week 16
|
2722 titer
Interval 1771.0 to 4183.0
|
—
|
—
|
2903 titer
Interval 814.0 to 10353.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Baseline
|
1530 titer
Interval 1013.0 to 2310.0
|
—
|
—
|
2616 titer
Interval 763.0 to 8966.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Day 7
|
2571 titer
Interval 1777.0 to 3720.0
|
—
|
—
|
2541 titer
Interval 757.0 to 8525.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Pre-vaccination 2 (Day 28)
|
2514 titer
Interval 1770.0 to 3569.0
|
—
|
—
|
2473 titer
Interval 848.0 to 7210.0
|
—
|
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Day 63
|
2969 titer
Interval 2070.0 to 4260.0
|
—
|
—
|
2642 titer
Interval 801.0 to 8720.0
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=5 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · Yes
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · No
|
5 Participants
|
17 Participants
|
17 Participants
|
4 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
0 Participants
|
6 Participants
|
16 Participants
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
5 Participants
|
14 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
5 Participants
|
19 Participants
|
18 Participants
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
0 Participants
|
7 Participants
|
13 Participants
|
1 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
5 Participants
|
12 Participants
|
7 Participants
|
4 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
0 Participants
|
6 Participants
|
8 Participants
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
5 Participants
|
12 Participants
|
12 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=5 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 63
|
0.14 titer
Interval 0.13 to 0.15
|
0.42 titer
Interval 0.21 to 0.82
|
0.64 titer
Interval 0.35 to 1.17
|
0.31 titer
Interval 0.07 to 1.31
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Baseline
|
0.21 titer
Interval 0.07 to 0.68
|
0.19 titer
Interval 0.15 to 0.24
|
0.22 titer
Interval 0.17 to 0.29
|
0.21 titer
Interval 0.14 to 0.32
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 7
|
0.19 titer
Interval 0.11 to 0.32
|
0.47 titer
Interval 0.26 to 0.86
|
5.3 titer
Interval 2.58 to 11.0
|
0.18 titer
Interval 0.13 to 0.26
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28)
|
0.16 titer
Interval 0.13 to 0.21
|
0.17 titer
Interval 0.14 to 0.19
|
0.27 titer
Interval 0.17 to 0.44
|
0.19 titer
Interval 0.1 to 0.34
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Day 35
|
0.14 titer
Interval 0.14 to 0.14
|
0.58 titer
Interval 0.3 to 1.13
|
1.34 titer
Interval 0.73 to 2.47
|
0.22 titer
Interval 0.06 to 0.74
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56)
|
0.14 titer
Interval 0.14 to 0.14
|
0.19 titer
Interval 0.13 to 0.28
|
0.25 titer
Interval 0.16 to 0.38
|
0.38 titer
Interval 0.06 to 2.29
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 63 · No
|
18 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 7 · Yes
|
13 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 7 · No
|
7 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
20 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 35 · Yes
|
7 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 35 · No
|
13 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 3 (Day 56) · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Pre-vaccination 3 (Day 56) · No
|
18 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Day 63 · Yes
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response
Baseline
|
0.63 titer
Interval 0.41 to 0.96
|
—
|
—
|
0.65 titer
Interval 0.43 to 0.98
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response
Day 7
|
4.93 titer
Interval 2.68 to 9.06
|
—
|
—
|
0.51 titer
Interval 0.24 to 1.09
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response
Pre-vaccination 2 (Day 28)
|
0.55 titer
Interval 0.37 to 0.81
|
—
|
—
|
0.42 titer
Interval 0.27 to 0.66
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response
Day 35
|
1.32 titer
Interval 0.77 to 2.24
|
—
|
—
|
0.38 titer
Interval 0.12 to 1.16
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response
Pre-vaccination 3 (Day 56)
|
0.60 titer
Interval 0.37 to 0.98
|
—
|
—
|
0.36 titer
Interval 0.17 to 0.75
|
—
|
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response
Day 63
|
0.94 titer
Interval 0.57 to 1.54
|
—
|
—
|
0.51 titer
Interval 0.18 to 1.44
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
19 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
19 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
18 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · No
|
18 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
19 Participants
|
—
|
—
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Day 35
|
0.28 titer
Interval 0.16 to 0.48
|
—
|
—
|
0.14 titer
Interval 0.14 to 0.14
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Baseline
|
0.20 titer
Interval 0.14 to 0.27
|
—
|
—
|
0.15 titer
Interval 0.13 to 0.17
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Day 7
|
0.23 titer
Interval 0.17 to 0.32
|
—
|
—
|
0.15 titer
Interval 0.12 to 0.18
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Pre-vaccination 2 (Day 28)
|
0.20 titer
Interval 0.14 to 0.28
|
—
|
—
|
0.17 titer
Interval 0.12 to 0.24
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Pre-vaccination 3 (Day 56)
|
0.19 titer
Interval 0.14 to 0.27
|
—
|
—
|
0.14 titer
Interval 0.14 to 0.14
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Day 63
|
0.25 titer
Interval 0.15 to 0.42
|
—
|
—
|
0.14 titer
Interval 0.14 to 0.14
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
19 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · Yes
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 2 (Day 28) · No
|
20 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
18 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Pre-vaccination 3 (Day 56) · No
|
19 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
20 Participants
|
—
|
—
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Pre-vaccination 3 (Day 56)
|
.19 titer
Interval 0.14 to 0.27
|
—
|
—
|
.14 titer
Interval 0.14 to 0.14
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Day 63
|
.17 titer
Interval 0.13 to 0.21
|
—
|
—
|
.15 titer
Interval 0.12 to 0.18
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Baseline
|
.17 titer
Interval 0.14 to 0.21
|
—
|
—
|
.14 titer
Interval 0.14 to 0.14
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Day 7
|
.21 titer
Interval 0.15 to 0.29
|
—
|
—
|
.14 titer
Interval 0.14 to 0.14
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Pre-vaccination 2 (Day 28)
|
.18 titer
Interval 0.14 to 0.23
|
—
|
—
|
.15 titer
Interval 0.13 to 0.17
|
—
|
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Day 35
|
.22 titer
Interval 0.14 to 0.36
|
—
|
—
|
.15 titer
Interval 0.13 to 0.17
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
3 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
17 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
3 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
16 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
4 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
14 Participants
|
—
|
—
|
3 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Week 16 · Yes
|
4 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Week 16 · No
|
13 Participants
|
—
|
—
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Results were included for subjects that received each vaccination and with usable samples.
Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3
Baseline
|
0.88 titer
Interval 0.39 to 1.94
|
—
|
—
|
21 titer
Interval 1.63 to 258.0
|
—
|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3
Day 7
|
1.02 titer
Interval 0.53 to 2.0
|
—
|
—
|
3.17 titer
Interval 0.22 to 45.0
|
—
|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3
Day 35
|
0.68 titer
Interval 0.32 to 1.45
|
—
|
—
|
3.66 titer
Interval 0.3 to 45.0
|
—
|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3
Day 63
|
0.94 titer
Interval 0.32 to 2.71
|
—
|
—
|
5.64 titer
Interval 0.35 to 90.0
|
—
|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3
Week 16
|
1.74 titer
Interval 0.59 to 5.11
|
—
|
—
|
6.75 titer
Interval 0.48 to 94.0
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
18 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
5 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
13 Participants
|
—
|
—
|
3 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Week 16 · Yes
|
5 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Week 16 · No
|
12 Participants
|
—
|
—
|
4 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
4 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
16 Participants
|
—
|
—
|
4 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Results were included for subjects that received each vaccination and with usable samples.
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3
Baseline
|
0.17 titer
Interval 0.02 to 0.57
|
—
|
—
|
0.23 titer
Interval 0.05 to 1.03
|
—
|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3
Day 7
|
0.14 titer
Interval 0.07 to 0.3
|
—
|
—
|
0.11 titer
Interval 0.02 to 0.57
|
—
|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3
Day 35
|
0.08 titer
Interval 0.04 to 0.15
|
—
|
—
|
0.08 titer
Interval 0.01 to 0.45
|
—
|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3
Day 63
|
0.12 titer
Interval 0.05 to 0.33
|
—
|
—
|
0.09 titer
Interval 0.01 to 0.69
|
—
|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3
Week 16
|
0.29 titer
Interval 0.13 to 0.67
|
—
|
—
|
0.16 titer
Interval 0.04 to 0.62
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
6 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
14 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
5 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
14 Participants
|
—
|
—
|
5 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
5 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
13 Participants
|
—
|
—
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 4
Baseline
|
0.52 titer
Interval 0.32 to 0.85
|
—
|
—
|
0.63 titer
Interval 0.14 to 2.73
|
—
|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 4
Day 7
|
1.31 titer
Interval 0.67 to 2.56
|
—
|
—
|
0.81 titer
Interval 0.17 to 3.74
|
—
|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 4
Day 35
|
0.87 titer
Interval 0.52 to 1.47
|
—
|
—
|
0.98 titer
Interval 0.14 to 6.69
|
—
|
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 4
Day 63
|
1.27 titer
Interval 0.59 to 2.7
|
—
|
—
|
0.66 titer
Interval 0.21 to 2.07
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 7 · Yes
|
7 Participants
|
—
|
—
|
2 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 7 · No
|
13 Participants
|
—
|
—
|
3 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 35 · Yes
|
7 Participants
|
—
|
—
|
3 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 35 · No
|
12 Participants
|
—
|
—
|
2 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 63 · Yes
|
8 Participants
|
—
|
—
|
2 Participants
|
—
|
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Day 63 · No
|
10 Participants
|
—
|
—
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 63 daysPopulation: Results were included for subjects that received each vaccination and with usable samples.
Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values \<0.15 were changed to 0.14.
Outcome measures
| Measure |
Cohort 2
n=20 Participants
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Cohort 1
n=5 Participants
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 4
Day 63
|
3.88 titer
Interval 0.97 to 15.0
|
—
|
—
|
3.98 titer
Interval 0.68 to 23.0
|
—
|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 4
Baseline
|
2.11 titer
Interval 0.81 to 5.5
|
—
|
—
|
1.35 titer
Interval 0.25 to 7.39
|
—
|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 4
Day 7
|
4.34 titer
Interval 1.18 to 16.0
|
—
|
—
|
2.06 titer
Interval 0.21 to 20.0
|
—
|
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 4
Day 35
|
4.01 titer
Interval 1.49 to 11.0
|
—
|
—
|
5.39 titer
Interval 0.47 to 61.0
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=5 participants at risk
Received one oral dose of 2.6±0.8 x 10\^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0
|
Cohort 2
n=20 participants at risk
Received three oral doses of 2.6±0.8 x 10\^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56
|
Cohort 3
n=20 participants at risk
Received three oral doses of 2.6±0.8 x 10\^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56
|
Cohort 4
n=20 participants at risk
Received three oral doses of 2.6±0.8 x 10\^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
Vaccine: 2.6±0.8 x 10\^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56
|
Placebo
n=17 participants at risk
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Eye disorders
Eye discharge
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
20.0%
4/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
15.0%
3/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
11.8%
2/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
20.0%
4/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
11.8%
2/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Infections and infestations
Muscle strain
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
15.0%
3/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
17.6%
3/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Blood urine present
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Eosinophil count decreased
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
15.0%
3/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
11.8%
2/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
11.8%
2/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Occult blood positive
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
Protein urine present
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Investigations
White blood cell count increased
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
15.0%
3/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
10.0%
2/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
15.0%
3/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
11.8%
2/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Reproductive system and breast disorders
Vaginal infection
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
10.0%
2/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.9%
1/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
10.0%
2/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
5.0%
1/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/20 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
0.00%
0/17 • 6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place