Trial Outcomes & Findings for Shigella WRSS1 Vaccine Trial in Bangladesh (NCT NCT02934178)
NCT ID: NCT02934178
Last Updated: 2020-03-31
Results Overview
All toddlers were monitored for evidence of immediate reactions, assessed for systemic reactogenicity (fever, irritability, decreased appetite, and decreased activity) and gastrointestinal (GI) symptoms (abdominal pain, nausea, vomiting, loose stool, diarrhea, dysentery, bloating, excess flatulence, constipation) during the 72 hours following each vaccine dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
72 hours after each vaccination (Day 3, Day 31, Day 59)
Results posted on
2020-03-31
Participant Flow
This was a single-site study conducted in Bangladesh. The study originally planned to enroll up to 64 toddlers to receive three doses of 3x10\^3, 3x10\^4, 3x10\^5 or 3x10\^6 colony-forming units (CFU) live attenuated, oral shigella WRSS1 vaccine or placebo, however enrollment was terminated after the first dose cohort was enrolled.
Participant milestones
| Measure |
Cohort 1: WRSS1 3x10³ CFU
Healthy toddlers received 3 oral doses of 3x10³ colony-forming unit (CFU) Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
Healthy toddlers received 3 oral doses of placebo to WRSS1 approximately 4 weeks apart.
|
|---|---|---|
|
Received Vaccination 1
STARTED
|
12
|
4
|
|
Received Vaccination 1
COMPLETED
|
12
|
4
|
|
Received Vaccination 1
NOT COMPLETED
|
0
|
0
|
|
Received Vaccination 2
STARTED
|
12
|
4
|
|
Received Vaccination 2
COMPLETED
|
12
|
3
|
|
Received Vaccination 2
NOT COMPLETED
|
0
|
1
|
|
Received Vaccination 3
STARTED
|
12
|
3
|
|
Received Vaccination 3
COMPLETED
|
11
|
3
|
|
Received Vaccination 3
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: WRSS1 3x10³ CFU
Healthy toddlers received 3 oral doses of 3x10³ colony-forming unit (CFU) Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
Healthy toddlers received 3 oral doses of placebo to WRSS1 approximately 4 weeks apart.
|
|---|---|---|
|
Received Vaccination 2
Death
|
0
|
1
|
|
Received Vaccination 3
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Shigella WRSS1 Vaccine Trial in Bangladesh
Baseline characteristics by cohort
| Measure |
Cohort 1: WRSS1
n=12 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=4 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.4 months
STANDARD_DEVIATION 3.03 • n=5 Participants
|
16.0 months
STANDARD_DEVIATION 1.41 • n=7 Participants
|
17.1 months
STANDARD_DEVIATION 2.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
76.0 cm
STANDARD_DEVIATION 4.01 • n=5 Participants
|
74.0 cm
STANDARD_DEVIATION 2.16 • n=7 Participants
|
75.5 cm
STANDARD_DEVIATION 3.68 • n=5 Participants
|
|
Weight
|
9.6 kilograms
STANDARD_DEVIATION 0.92 • n=5 Participants
|
9.0 kilograms
STANDARD_DEVIATION 0.34 • n=7 Participants
|
9.4 kilograms
STANDARD_DEVIATION 0.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: 72 hours after each vaccination (Day 3, Day 31, Day 59)All toddlers were monitored for evidence of immediate reactions, assessed for systemic reactogenicity (fever, irritability, decreased appetite, and decreased activity) and gastrointestinal (GI) symptoms (abdominal pain, nausea, vomiting, loose stool, diarrhea, dysentery, bloating, excess flatulence, constipation) during the 72 hours following each vaccine dose.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=12 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=4 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Maximum Severity of Reactogenicity by Vaccination
Fever · Mild
|
1 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Fever · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Fever · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Fever · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Fever · None
|
11 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased appetite · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased appetite · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased appetite · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased appetite · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased appetite · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Irritability · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Irritability · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Irritability · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Irritability · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Irritability · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased activity · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased activity · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased activity · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased activity · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Decreased activity · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Abdominal pain · Mild
|
0 Participants
|
1 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Abdominal pain · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Abdominal pain · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Abdominal pain · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Abdominal pain · None
|
12 Participants
|
3 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Nausea · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Nausea · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Nausea · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Nausea · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Nausea · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Vomiting · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Vomiting · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Vomiting · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Loose stool · Mild
|
5 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Loose stool · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Loose stool · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Loose stool · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Loose stool · None
|
7 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Diarrhea · Mild
|
1 Participants
|
1 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Diarrhea · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Diarrhea · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Diarrhea · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Diarrhea · None
|
11 Participants
|
3 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Dysentery · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Dysentery · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Dysentery · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Dysentery · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Dysentery · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Bloating · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Bloating · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Bloating · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Bloating · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Bloating · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Excess flatulence · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Excess flatulence · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Excess flatulence · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Excess flatulence · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Excess flatulence · None
|
12 Participants
|
4 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Constipation · Mild
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Constipation · Moderate
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Constipation · Severe
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Constipation · Life Threatening
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Reactogenicity by Vaccination
Constipation · None
|
12 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after any vaccination (up to Day 84)Population: Safety population
All toddlers were monitored for the occurrence of any adverse event (AE) or serious adverse event (SAE). Toddlers visited the clinic for safety assessments approximately one month after each vaccination. Grades are based on maximum severity per participant.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=12 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=4 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
Any adverse events: Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
Any adverse events: Moderate
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
Any adverse events: Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
Any adverse events: Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
Any adverse events: Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
Any adverse events: Total
|
11 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
AEs related to study vaccine: Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
AEs related to study vaccine: Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
AEs related to study vaccine: Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
AEs related to study vaccine: Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
AEs related to study vaccine: Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
AEs related to study vaccine: Total
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgA response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Day 0
|
0.09 titer
Interval 0.05 to 0.15
|
0.07 titer
Interval 0.04 to 0.12
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Day 7
|
0.07 titer
Interval 0.07 to 0.08
|
0.06 titer
Interval 0.06 to 0.06
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Day 35
|
0.07 titer
Interval 0.07 to 0.07
|
0.07 titer
Interval 0.05 to 0.09
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Day 63
|
0.07 titer
Interval 0.07 to 0.08
|
0.07 titer
Interval 0.05 to 0.09
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei lipopolysaccharide (LPS) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants from cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgA response from circulating lymphocytes.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 0
|
0.07 titer
Interval 0.07 to 0.07
|
0.06 titer
Interval 0.05 to 0.08
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7
|
0.07 titer
Interval 0.06 to 0.08
|
0.07 titer
Interval 0.06 to 0.07
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35
|
0.07 titer
Interval 0.06 to 0.08
|
0.07 titer
Interval 0.06 to 0.07
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63
|
0.09 titer
Interval 0.05 to 0.19
|
0.06 titer
Interval 0.06 to 0.07
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgG response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 0
|
0.10 titer
Interval 0.06 to 0.18
|
0.15 titer
Interval 0.01 to 1.94
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7
|
0.15 titer
Interval 0.06 to 0.34
|
0.19 titer
Interval 0.01 to 2.8
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35
|
0.09 titer
Interval 0.07 to 0.13
|
0.11 titer
Interval 0.04 to 0.27
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63
|
0.14 titer
Interval 0.06 to 0.3
|
0.12 titer
Interval 0.05 to 0.29
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgG response from circulating lymphocytes.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Day 0
|
0.07 titer
Interval 0.06 to 0.07
|
0.08 titer
Interval 0.04 to 0.15
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Day 7
|
0.10 titer
Interval 0.04 to 0.23
|
0.08 titer
Interval 0.06 to 0.1
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Day 35
|
0.07 titer
Interval 0.07 to 0.08
|
0.08 titer
Interval 0.04 to 0.17
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Day 63
|
0.11 titer
Interval 0.05 to 0.24
|
0.08 titer
Interval 0.04 to 0.16
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgM response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 0
|
0.08 titer
Interval 0.07 to 0.1
|
0.10 titer
Interval 0.03 to 0.3
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7
|
0.14 titer
Interval 0.05 to 0.41
|
0.09 titer
Interval 0.08 to 0.11
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35
|
0.08 titer
Interval 0.07 to 0.09
|
0.08 titer
Interval 0.06 to 0.12
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63
|
0.12 titer
Interval 0.07 to 0.2
|
0.09 titer
Interval 0.05 to 0.15
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgM response from circulating lymphocytes.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 0
|
0.07 titer
Interval 0.06 to 0.08
|
0.09 titer
Interval 0.06 to 0.14
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7
|
0.13 titer
Interval 0.04 to 0.47
|
0.08 titer
Interval 0.08 to 0.09
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35
|
0.08 titer
Interval 0.07 to 0.1
|
0.09 titer
Interval 0.07 to 0.1
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63
|
0.11 titer
Interval 0.06 to 0.23
|
0.11 titer
Interval 0.04 to 0.31
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Day 7
|
1.01 fold change
Interval 0.98 to 1.04
|
0.98 fold change
Interval 0.98 to 0.98
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Day 35
|
0.77 fold change
Interval 0.43 to 1.38
|
1.00 fold change
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Day 63
|
0.79 fold change
Interval 0.43 to 1.48
|
0.96 fold change
Interval 0.6 to 1.55
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7
|
1.00 fold change
Interval 0.95 to 1.04
|
1.10 fold change
Interval 1.1 to 1.1
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35
|
1.03 fold change
Interval 0.93 to 1.14
|
1.07 fold change
Interval 0.58 to 1.95
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63
|
1.39 fold change
Interval 0.68 to 2.8
|
1.04 fold change
Interval 0.51 to 2.11
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7
|
1.45 fold change
Interval 0.65 to 3.24
|
1.32 fold change
Interval 1.12 to 1.55
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35
|
0.93 fold change
Interval 0.72 to 1.2
|
0.73 fold change
Interval 0.14 to 3.83
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63
|
1.38 fold change
Interval 0.48 to 3.97
|
0.82 fold change
Interval 0.06 to 11.01
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Day 7
|
1.48 fold change
Interval 0.63 to 3.44
|
1.00 fold change
Interval 0.42 to 2.37
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Day 35
|
1.04 fold change
Interval 0.99 to 1.11
|
1.07 fold change
Interval 0.99 to 1.15
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Day 63
|
1.58 fold change
Interval 0.7 to 3.57
|
1.04 fold change
Interval 1.02 to 1.06
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7
|
1.64 fold change
Interval 0.53 to 5.11
|
0.90 fold change
Interval 0.32 to 2.51
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35
|
0.98 fold change
Interval 0.83 to 1.15
|
0.78 fold change
Interval 0.24 to 2.56
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63
|
1.39 fold change
Interval 0.77 to 2.49
|
0.87 fold change
Interval 0.21 to 3.66
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7
|
1.83 fold change
Interval 0.5 to 6.7
|
0.91 fold change
Interval 0.61 to 1.36
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35
|
1.12 fold change
Interval 0.93 to 1.36
|
0.93 fold change
Interval 0.63 to 1.37
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63
|
1.58 fold change
Interval 0.75 to 3.31
|
1.18 fold change
Interval 0.51 to 2.71
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7 · Less than 4-fold rise
|
5 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35 · Less than 4-fold rise
|
8 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63 · Less than 4-fold rise
|
7 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
At any time · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
At any time · Less than 4-fold rise
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
At any time · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
At any time · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 7 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 35 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Day 63 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
At any time · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
At any time · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7 · Less than 4-fold rise
|
8 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35 · Less than 4-fold rise
|
11 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63 · Less than 4-fold rise
|
10 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
At any time · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
At any time · Less than 4-fold rise
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
At any time · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
At any time · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 7 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Day 63 · Less than 4-fold rise
|
8 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
At any time · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
At any time · Less than 4-fold rise
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the enzyme-linked immunosorbent assay (ELISA) plates.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Day 0
|
0.17 titer
Interval 0.05 to 0.62
|
0.12 titer
Interval 0.05 to 0.28
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Day 7
|
0.17 titer
Interval 0.05 to 0.58
|
0.10 titer
Interval 0.08 to 0.12
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Day 35
|
0.16 titer
Interval 0.05 to 0.49
|
0.12 titer
Interval 0.04 to 0.34
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Day 63
|
0.36 titer
Interval 0.05 to 2.54
|
0.13 titer
Interval 0.06 to 0.25
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific lipopolysaccharide (LPS) from the Walter Reed Army Institute was used to coat the ELISA plates.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 0
|
0.10 titer
Interval 0.08 to 0.12
|
0.10 titer
Interval 0.05 to 0.21
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 7
|
0.11 titer
Interval 0.09 to 0.12
|
0.09 titer
Interval 0.07 to 0.12
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 35
|
0.09 titer
Interval 0.08 to 0.11
|
0.57 titer
Interval 0.0 to 1380.56
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 63
|
0.32 titer
Interval 0.05 to 2.01
|
0.54 titer
Interval 0.0 to 1483.02
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Day 0
|
66.79 titer
Interval 16.02 to 278.37
|
95.23 titer
Interval 3.46 to 2620.02
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Day 7
|
3.76 titer
Interval 0.28 to 49.97
|
82.78 titer
Interval 15.7 to 436.37
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Day 35
|
146.08 titer
Interval 81.56 to 261.61
|
119.79 titer
Interval 6.35 to 2260.2
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Day 63
|
29.44 titer
Interval 4.61 to 188.01
|
147.73 titer
Interval 10.62 to 2054.85
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Day 0
|
5.02 titer
Interval 0.79 to 32.02
|
1.00 titer
Interval 0.0 to 2664.32
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Day 7
|
0.68 titer
Interval 0.12 to 3.88
|
0.16 titer
Interval 0.11 to 0.25
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Day 35
|
14.97 titer
Interval 3.18 to 70.47
|
1.03 titer
Interval 0.0 to 2926.12
|
|
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Day 63
|
4.63 titer
Interval 0.69 to 30.93
|
1.06 titer
Interval 0.0 to 2740.34
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen
Day 0
|
119.55 titer
Interval 74.94 to 190.7
|
107.03 titer
Interval 5.1 to 2247.74
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen
Day 7
|
177.34 titer
Interval 109.85 to 286.29
|
116.79 titer
Interval 12.32 to 1107.43
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen
Day 35
|
188.41 titer
Interval 95.77 to 370.66
|
180.28 titer
Interval 7.23 to 4492.8
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen
Day 63
|
208.53 titer
Interval 121.7 to 357.3
|
198.66 titer
Interval 12.57 to 3140.08
|
SECONDARY outcome
Timeframe: Days 0, 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 0
|
102.80 titer
Interval 74.11 to 142.58
|
108.10 titer
Interval 5.27 to 2217.26
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 7
|
146.48 titer
Interval 100.59 to 213.31
|
117.38 titer
Interval 12.07 to 1141.64
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 35
|
117.25 titer
Interval 86.44 to 159.03
|
174.98 titer
Interval 7.28 to 4206.87
|
|
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 63
|
179.07 titer
Interval 93.31 to 343.68
|
148.62 titer
Interval 16.32 to 1353.41
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Day 7
|
0.97 fold change
Interval 0.82 to 1.15
|
0.84 fold change
Interval 0.4 to 1.76
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Day 35
|
0.95 fold change
Interval 0.74 to 1.2
|
0.98 fold change
Interval 0.77 to 1.23
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Day 63
|
2.18 fold change
Interval 0.2 to 24.36
|
1.08 fold change
Interval 0.89 to 1.3
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 7
|
1.05 fold change
Interval 0.83 to 1.33
|
0.90 fold change
Interval 0.5 to 1.6
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 35
|
0.94 fold change
Interval 0.78 to 1.14
|
5.47 fold change
Interval 0.0 to 6647.02
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 63
|
3.18 fold change
Interval 0.52 to 19.56
|
5.19 fold change
Interval 0.0 to 7147.44
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Day 7
|
0.06 fold change
Interval 0.01 to 0.67
|
0.87 fold change
Interval 0.12 to 6.14
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Day 35
|
2.19 fold change
Interval 0.7 to 6.88
|
1.26 fold change
Interval 0.59 to 2.67
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Day 63
|
0.45 fold change
Interval 0.04 to 4.63
|
1.55 fold change
Interval 0.21 to 11.37
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Day 7
|
0.13 fold change
Interval 0.01 to 2.68
|
0.16 fold change
Interval 0.0 to 428.26
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Day 35
|
2.98 fold change
Interval 0.78 to 11.46
|
1.03 fold change
Interval 0.76 to 1.38
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Day 63
|
0.93 fold change
Interval 0.06 to 14.47
|
1.06 fold change
Interval 0.75 to 1.51
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen
Day 7
|
1.48 fold change
Interval 1.0 to 2.2
|
1.09 fold change
Interval 0.47 to 2.51
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen
Day 35
|
1.58 fold change
Interval 0.9 to 2.77
|
1.68 fold change
Interval 1.31 to 2.17
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen
Day 63
|
1.74 fold change
Interval 1.32 to 2.3
|
1.86 fold change
Interval 1.28 to 2.7
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 7
|
1.43 fold change
Interval 1.07 to 1.89
|
1.09 fold change
Interval 0.51 to 2.29
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 35
|
1.14 fold change
Interval 0.78 to 1.67
|
1.62 fold change
Interval 0.98 to 2.67
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Day 63
|
1.74 fold change
Interval 1.09 to 2.78
|
1.37 fold change
Interval 0.55 to 3.46
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
Day 7 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
Day 7 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
Day 35 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
Day 63 · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
Day 63 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
At any time · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
At any time · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
Day 7 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
Day 7 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
Day 35 · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
Day 35 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
Day 63 · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
Day 63 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
At any time · 4-fold rise or higher
|
3 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
At any time · Less than 4-fold rise
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
Day 7 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
Day 7 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
Day 35 · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
Day 35 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
Day 63 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
At any time · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
At any time · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 7 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 7 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 35 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 63 · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 63 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
At any time · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
At any time · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 7 · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 7 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 35 · 4-fold rise or higher
|
2 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 35 · Less than 4-fold rise
|
9 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 63 · 4-fold rise or higher
|
4 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 63 · Less than 4-fold rise
|
7 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
At any time · 4-fold rise or higher
|
4 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
At any time · Less than 4-fold rise
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 7, 35, and 63Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 7 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 7 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 35 · 4-fold rise or higher
|
0 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 35 · Less than 4-fold rise
|
11 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 63 · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Day 63 · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
At any time · 4-fold rise or higher
|
1 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
At any time · Less than 4-fold rise
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 28, 35, 56, 63, and 84Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei Invaplex in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 0
|
0.78 titer
Interval 0.3 to 2.04
|
0.48 titer
Interval 0.0 to 179.8
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 7
|
1.74 titer
Interval 0.82 to 3.7
|
0.65 titer
Interval 0.01 to 30.02
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 28
|
1.61 titer
Interval 0.73 to 3.54
|
1.23 titer
Interval 0.02 to 89.76
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 35
|
1.59 titer
Interval 0.68 to 3.68
|
0.61 titer
Interval 0.02 to 16.33
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 56
|
1.12 titer
Interval 0.34 to 3.63
|
1.77 titer
Interval 0.01 to 478.8
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 63
|
1.44 titer
Interval 0.5 to 4.15
|
1.48 titer
Interval 0.28 to 7.73
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 84
|
0.95 titer
Interval 0.33 to 2.69
|
0.52 titer
Interval 0.04 to 6.39
|
SECONDARY outcome
Timeframe: Days 0, 7, 28, 35, 56, 63, and 84Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei LPS in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 0
|
1.85 titer
Interval 0.59 to 5.8
|
0.80 titer
Interval 0.02 to 41.16
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 7
|
3.43 titer
Interval 1.31 to 9.04
|
0.58 titer
Interval 0.02 to 21.65
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 28
|
2.99 titer
Interval 1.33 to 6.72
|
1.53 titer
Interval 0.22 to 10.5
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 35
|
3.00 titer
Interval 1.14 to 7.88
|
0.29 titer
Interval 0.01 to 6.35
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 56
|
2.08 titer
Interval 0.62 to 6.96
|
3.51 titer
Interval 0.06 to 211.2
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 63
|
2.05 titer
Interval 0.52 to 8.04
|
1.82 titer
Interval 0.32 to 10.5
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 84
|
1.89 titer
Interval 0.52 to 6.83
|
0.43 titer
Interval 0.01 to 18.2
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens
Day 7
|
1.88 fold change
Interval 0.55 to 6.48
|
1.37 fold change
Interval 0.02 to 111.27
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens
Day 28
|
2.27 fold change
Interval 0.48 to 10.76
|
2.58 fold change
Interval 0.01 to 1074.7
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens
Day 35
|
1.74 fold change
Interval 0.56 to 5.37
|
1.28 fold change
Interval 0.01 to 194.78
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens
Day 56
|
1.44 fold change
Interval 0.26 to 7.99
|
14.69 fold change
Interval 0.24 to 909.75
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens
Day 63
|
1.85 fold change
Interval 0.37 to 9.34
|
3.12 fold change
Interval 0.0 to 2395.67
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens
Day 84
|
1.25 fold change
Interval 0.26 to 5.95
|
1.10 fold change
Interval 0.0 to 5008.88
|
SECONDARY outcome
Timeframe: Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 7
|
1.84 fold change
Interval 0.45 to 7.59
|
0.72 fold change
Interval 0.0 to 108.85
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 28
|
1.64 fold change
Interval 0.38 to 7.0
|
1.90 fold change
Interval 0.01 to 639.87
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 35
|
1.24 fold change
Interval 0.3 to 5.09
|
0.36 fold change
Interval 0.0 to 334.23
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 56
|
1.14 fold change
Interval 0.19 to 6.72
|
9.19 fold change
Interval 0.0 to 20438.76
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 63
|
1.11 fold change
Interval 0.22 to 5.62
|
2.27 fold change
Interval 0.01 to 420.54
|
|
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 84
|
0.95 fold change
Interval 0.16 to 5.69
|
0.53 fold change
Interval 0.0 to 97.74
|
SECONDARY outcome
Timeframe: Days 7, 28, 35, 56, 63, and 84Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 7 · 4-fold rise or higher
|
3 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 7 · Less than 4-fold rise
|
7 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 28 · 4-fold rise or higher
|
4 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 28 · Less than 4-fold rise
|
6 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 35 · 4-fold rise or higher
|
3 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 35 · Less than 4-fold rise
|
7 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 56 · 4-fold rise or higher
|
4 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 56 · Less than 4-fold rise
|
7 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 63 · 4-fold rise or higher
|
4 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 63 · Less than 4-fold rise
|
7 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 84 · 4-fold rise or higher
|
3 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Day 84 · Less than 4-fold rise
|
7 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
At any time · 4-fold rise or higher
|
6 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
At any time · Less than 4-fold rise
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 7, 28, 35, 56, 63, and 84Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
Outcome measures
| Measure |
Cohort 1: WRSS1
n=11 Participants
Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=3 Participants
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 7 · 4-fold rise or higher
|
4 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 7 · Less than 4-fold rise
|
6 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 28 · 4-fold rise or higher
|
5 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 28 · Less than 4-fold rise
|
5 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 35 · 4-fold rise or higher
|
2 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 35 · Less than 4-fold rise
|
8 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 56 · 4-fold rise or higher
|
3 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 56 · Less than 4-fold rise
|
8 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 63 · 4-fold rise or higher
|
3 Participants
|
1 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 63 · Less than 4-fold rise
|
8 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 84 · 4-fold rise or higher
|
4 Participants
|
0 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Day 84 · Less than 4-fold rise
|
6 Participants
|
3 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
At any time · 4-fold rise or higher
|
6 Participants
|
2 Participants
|
|
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
At any time · Less than 4-fold rise
|
5 Participants
|
1 Participants
|
Adverse Events
Cohort 1: WRSS1
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1: WRSS1
n=12 participants at risk
Healthy toddlers received 3 oral doses of 3x10³ colony-forming unit (CFU) Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=4 participants at risk
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
General disorders
Sudden death
|
0.00%
0/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
25.0%
1/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
Other adverse events
| Measure |
Cohort 1: WRSS1
n=12 participants at risk
Healthy toddlers received 3 oral doses of 3x10³ colony-forming unit (CFU) Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
|
Cohort 1: Placebo
n=4 participants at risk
Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
5/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
50.0%
2/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Gastrointestinal disorders
Mucous stools
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
General disorders
Pyrexia
|
16.7%
2/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
25.0%
1/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Furuncle
|
16.7%
2/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
25.0%
1/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Measles
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Nasopharyngitis
|
41.7%
5/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
25.0%
1/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Otitis externa
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Otitis media
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Otitis media acute
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Respiratory tract infection
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
25.0%
1/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
25.0%
1/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Upper respiratory tract infection
|
58.3%
7/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Infections and infestations
Varicella
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Nervous system disorders
Febrile convulsion
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.3%
1/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
0.00%
0/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
5/12 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
25.0%
1/4 • Serious adverse events were collected through Day 224. Non-serious adverse events are reported through 28 days after any vaccination (up to Day 84).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place