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Trial record 29 of 37 for:    "Shigellosis"

Safety Study of Live Attenuated Oral Shigella (WRSS1) Vaccine in Bangladeshi Adults and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01813071
Recruitment Status : Completed
First Posted : March 18, 2013
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Diarrhea
Intervention Biological: WRSS1
Enrollment 103
Recruitment Details Participants in general good health were recruited, screened and consented at the icddr,b Dhaka in Bangladesh. Final eligibility was determined by fulfillment of all the inclusion and absence of any of the exclusion criteria. Adults were enrolled August 23, 2013 to November 10, 2013 and children were enrolled April 27, 2014 to August 9, 2015.
Pre-assignment Details  
Arm/Group Title Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part A (Adults): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4 Part B (Children): Placebo
Hide Arm/Group Description One oral dose of ~3x10^4 cfu WRSS1 Three oral doses of ~3x10^5 cfu WRSS1 Three oral doses of ~3x10^6 cfu WRSS1 One or Three oral doses of Placebo One oral dose of ~3x10^3 cfu WRSS1 Three oral doses of ~3x10^4 cfu WRSS1 Three oral doses of ~3x10^5 cfu WRSS1 Three oral doses of ~3x10^6 cfu WRSS1 One or three oral doses of Placebo
Period Title: Overall Study
Started 10 10 10 9 12 12 12 12 16
Completed 10 10 10 9 11 5 9 7 13
Not Completed 0 0 0 0 1 7 3 5 3
Reason Not Completed
Protocol Violation             0             0             0             0             1             4             2             4             2
Withdrawal by Subject             0             0             0             0             0             1             0             0             0
Adverse Event             0             0             0             0             0             1             0             0             0
Physician Decision             0             0             0             0             0             0             1             0             0
Met inc/exc criteria             0             0             0             0             0             1             0             1             1
Arm/Group Title Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part A (Adults): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4 Part B (Children): Placebo Total
Hide Arm/Group Description One oral dose of ~3x10^4 cfu WRSS1 Three oral doses of ~3x10^5 cfu WRSS1 Three oral doses of ~3x10^6 cfu WRSS1 One or Three oral doses of Placebo One oral dose of ~3x10^3 cfu WRSS1 Three oral doses of ~3x10^4 cfu WRSS1 Three oral doses of ~3x10^5 cfu WRSS1 Three oral doses of ~3x10^6 cfu WRSS1 One or three oral doses of Placebo Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 9 12 12 12 12 16 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Part A Adults Number Analyzed 10 participants 10 participants 10 participants 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 39 participants
25.7  (5.23) 28.1  (5.51) 27.0  (2.67) 27.4  (5.34) 27.1  (4.71)
Part B Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 12 participants 12 participants 12 participants 12 participants 16 participants 64 participants
6.3  (0.98) 6.6  (1.16) 6.0  (0.85) 6.3  (0.97) 6.6  (1.02) 6.4  (1.00)
[1]
Measure Analysis Population Description: Additional row added to stratify participants by 'adults' and 'children' and give totals for each.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 12 participants 12 participants 12 participants 12 participants 16 participants 103 participants
Female
5
  50.0%
5
  50.0%
7
  70.0%
4
  44.4%
8
  66.7%
8
  66.7%
9
  75.0%
5
  41.7%
12
  75.0%
63
  61.2%
Male
5
  50.0%
5
  50.0%
3
  30.0%
5
  55.6%
4
  33.3%
4
  33.3%
3
  25.0%
7
  58.3%
4
  25.0%
40
  38.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Bangladesh Number Analyzed 10 participants 10 participants 10 participants 9 participants 12 participants 12 participants 12 participants 12 participants 16 participants 103 participants
10 10 10 9 12 12 12 12 16 103
Height (cm)   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Part A Adults Number Analyzed 10 participants 10 participants 10 participants 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 39 participants
160.7  (10.75) 160.1  (9.47) 157.0  (6.36) 159.2  (10.07) 159.3  (9.03)
Part B Children Number Analyzed 0 participants 0 participants 0 participants 0 participants 12 participants 12 participants 12 participants 12 participants 16 participants 64 participants
116.4  (4.66) 116.4  (8.32) 115.0  (4.86) 121.0  (6.74) 119.4  (7.91) 117.8  (6.90)
[1]
Measure Analysis Population Description: Additional row added to stratify participants by 'adults' and 'children' and give totals for each.
Weight (kg)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Part A (Adults) Number Analyzed 10 participants 10 participants 10 participants 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 39 participants
67.3  (13.98) 58.1  (11.52) 54.5  (8.43) 56.4  (11.52) 59.2  (12.16)
Part B (Children) Number Analyzed 0 participants 0 participants 0 participants 0 participants 12 participants 12 participants 12 participants 12 participants 16 participants 64 participants
19.7  (1.64) 20.5  (4.09) 21.3  (4.26) 22.9  (4.62) 21.0  (3.81) 21.1  (3.85)
[1]
Measure Analysis Population Description: Additional row added to stratify participants by 'adults' and 'children' and give totals for each
1.Primary Outcome
Title Number and Percentage of Participants With Serious Adverse Events (SAEs)
Hide Description Based on maximum severity per participant over all serious adverse events (SAEs) within 6 months of any vaccination. A Serious Adverse Event, including serious suspected adverse reaction or serious adverse reaction as determined by the Investigator or the sponsor, was any event that results in any of the following outcomes: Inpatient hospitalization or prolongation of existing hospitalization , life-threatening AE that in the opinion of the investigator or sponsor put the participant at immediate risk of death, persistent or significant incapacity or substantial disruption, congenital abnormality or birth defect, a medically important event that may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed or death.
Time Frame Day -1(admission day) through 6 months (Day 224 +/- 14 days) after the third vaccination for Cohorts A2,A3, B2, B3, B4, and after the first vaccination (Day 168 +/- 14 days) for Cohorts A1 and B1.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety.
Arm/Group Title Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part A (Adults): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4 Part B (Children): Placebo
Hide Arm/Group Description:
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or Three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
Overall Number of Participants Analyzed 10 10 10 9 12 12 12 12 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
1
   8.3%
1
   6.3%
2.Primary Outcome
Title Number and Percentage of Participants With Any Non-serious Unsolicited Adverse Events
Hide Description Based on subject count over all non-serious adverse events. An Adverse event was defined as any untoward medical occurrence in humans, whether or not considered drug related, that occurred during the conduct of a clinical trial. Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that was considered clinically significant by the study investigator, was considered an AE. This definition also included an exacerbation or worsening of pre-existing conditions or events, inter-current illnesses, injuries, or vaccine or drug interaction, or worsening of abnormal clinical laboratory values. All AEs were assessed by the clinician using a protocol defined grading system.
Time Frame Day -1(admission day) through 6 months (Day 224 +/- 14 days) after the third vaccination for Cohorts A2,A3, B2, B3, B4, and after the first vaccination (Day 168 +/- 14 days) for Cohorts A1 and B1.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety.
Arm/Group Title Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part A (Adults): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4 Part B (Children): Placebo
Hide Arm/Group Description:
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or Three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
Overall Number of Participants Analyzed 10 10 10 9 12 12 12 12 16
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
7
  70.0%
8
  80.0%
6
  66.7%
10
  83.3%
9
  75.0%
9
  75.0%
12
 100.0%
12
  75.0%
3.Primary Outcome
Title Number and Percentage of Participants With Solicited Systemic and Intestinal Reactions
Hide Description Maximum severity per participant of any systemic or any gastrointestinal reactogenicity recorded within 7 days of any vaccination is reported. Solicited Systemic reactogenicity events assessed included fever, headache, malaise, generalized myalgia, arthralgia, chills, reactive arthritis and decreased appetite. Intestinal solicited reactogenicity events assessed included abdominal cramps, abdominal pain, nausea, vomiting, loose stool, diarrhea, dysentery, bloating, excess flatulence and constipation. Diarrhea and dysentery were assessed both during inpatient (first three day period post-vaccination) and outpatient ( post-vaccination days 4-7) periods post-vaccination 1. Vaccinations 2 and 3 did not have an inpatient admission period for any participants. Diarrhea severity was determined on the basis of stool number, grading and stool weight during the inpatient period and by stool number and grading only during the outpatient period.
Time Frame Day 0 through Day 7 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety.
Arm/Group Title Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part A (Adults): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4 Part B (Children): Placebo
Hide Arm/Group Description:
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or Three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
Overall Number of Participants Analyzed 10 10 10 9 12 12 12 12 16
Measure Type: Count of Participants
Unit of Measure: Participants
Any Systemic Reactogenicity
2
  20.0%
1
  10.0%
6
  60.0%
4
  44.4%
0
   0.0%
3
  25.0%
0
   0.0%
4
  33.3%
2
  12.5%
Any Gastrointestinal Reactogenicity
2
  20.0%
4
  40.0%
7
  70.0%
4
  44.4%
2
  16.7%
4
  33.3%
3
  25.0%
6
  50.0%
2
  12.5%
4.Primary Outcome
Title Number and Percentage of Participants With Any Unsolicited AEs and SAEs Judged as Having a Reasonable Possibility That the Study Product Caused the Event
Hide Description Adverse event (AE) was defined as any untoward medical occurrence in humans, whether or not considered drug related, that occurs during the conduct of a clinical trial. A Serious Adverse Event (SAE) , including serious suspected adverse reaction or serious adverse reaction as determined by the Investigator or the sponsor, was any event that results in any of the following outcomes: Inpatient hospitalization or prolongation of existing hospitalization , life-threatening AE that in the opinion of the investigator or sponsor put the participant at immediate risk of death, persistent or significant incapacity or substantial disruption, congenital abnormality or birth defect, a medically important event that may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed or death. Causality of the AE/SAE to the study drug was assessed by the Investigator as reasonable possibility that the study product caused the reported event.
Time Frame SAEs at any time and AEs after any vaccination until Day 168 (Cohort A1, B1) and Day 224 (all other Cohorts).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety. Adult Cohort A1 and Child Cohort B1 only received a single dose of study vaccine.
Arm/Group Title Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part A (Adults): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4 Part B (Children): Placebo
Hide Arm/Group Description:
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or Three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
Overall Number of Participants Analyzed 10 10 10 9 12 12 12 12 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Titers in Lymphocyte Supernatant (ALS)
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific immunoglobulin A (IgA) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and a novel composition comprising invasin proteins and LPS from gram-negative bacteria (Invaplex) using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
3
  30.0%
6
  60.0%
7
  87.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
3
  30.0%
LPS
0
   0.0%
3
  30.0%
7
  70.0%
7
  87.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
3
  30.0%
6.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 5 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
2
  20.0%
4
  50.0%
1
   9.1%
0
   0.0%
1
   9.1%
3
  30.0%
LPS
0
   0.0%
2
  20.0%
4
  50.0%
0
   0.0%
0
   0.0%
1
   9.1%
2
  20.0%
7.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer..
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
1
  10.0%
3
  37.5%
0
   0.0%
0
   0.0%
0
   0.0%
3
  30.0%
LPS
0
   0.0%
1
  10.0%
5
  62.5%
0
   0.0%
0
   0.0%
1
   9.1%
3
  30.0%
8.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame At any time (Day 7 to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
3
  30.0%
7
  70.0%
8
 100.0%
1
   6.7%
0
   0.0%
0
   0.0%
2
  18.2%
4
  40.0%
LPS
0
   0.0%
3
  30.0%
7
  70.0%
8
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  27.3%
4
  40.0%
9.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in Immunoglobulin G (IgG ) IgG Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific immunoglobulin G (IgG ) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
3
  30.0%
3
  30.0%
4
  50.0%
0
   0.0%
1
   8.3%
0
   0.0%
1
   9.1%
1
  10.0%
LPS
0
   0.0%
2
  20.0%
6
  60.0%
7
  87.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
4
  40.0%
10.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 5 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
  20.0%
3
  30.0%
1
  12.5%
1
   9.1%
1
  12.5%
3
  27.3%
2
  20.0%
LPS
0
   0.0%
4
  40.0%
6
  75.0%
0
   0.0%
0
   0.0%
1
   9.1%
2
  20.0%
11.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS: Invaplex
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 7 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
2
  20.0%
2
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  40.0%
12.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS: Lipopolysaccharide (LPS)
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  20.0%
6
  75.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  30.0%
13.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame At any time (Day 7 to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
  11.1%
3
  30.0%
5
  50.0%
5
  62.5%
1
   6.7%
1
   8.3%
1
  12.5%
3
  27.3%
5
  50.0%
LPS
0
   0.0%
2
  20.0%
7
  70.0%
8
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  18.2%
5
  50.0%
14.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific immunoglobulin M (IgM) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS: Invaplex
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 6 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
   9.1%
0
   0.0%
1
   9.1%
1
  10.0%
16.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS: LPS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
17.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS: Invaplex
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 6 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
18.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS : LPS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 6 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS
Hide Description The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the ‘antibodies in lymphocyte supernatant’ (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame At any time (Day 7 to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
2
  13.3%
0
   0.0%
0
   0.0%
1
   9.1%
2
  20.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
20.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
  11.1%
1
  10.0%
3
  30.0%
2
  25.0%
1
   6.7%
1
   8.3%
0
   0.0%
3
  27.3%
2
  20.0%
LPS
1
  11.1%
1
  10.0%
3
  30.0%
4
  50.0%
1
   6.7%
0
   0.0%
0
   0.0%
2
  18.2%
3
  30.0%
21.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
1
  10.0%
22.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 5 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
2
  20.0%
0
   0.0%
2
  18.2%
1
  12.5%
1
   9.1%
3
  30.0%
LPS
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  18.2%
5
  50.0%
23.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
2
  20.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
1
  16.7%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  18.2%
2
  20.0%
24.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
1
  10.0%
0
   0.0%
1
   9.1%
0
   0.0%
1
   9.1%
4
  40.0%
LPS
0
   0.0%
0
   0.0%
1
  12.5%
2
  18.2%
2
  28.6%
3
  27.3%
3
  30.0%
25.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
3
  30.0%
0
   0.0%
1
   9.1%
0
   0.0%
1
   9.1%
1
  10.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
26.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame At any time (Day 7 to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
  11.1%
1
  10.0%
7
  70.0%
2
  25.0%
3
  20.0%
1
   8.3%
1
  12.5%
4
  36.4%
6
  60.0%
LPS
2
  22.2%
1
  10.0%
5
  50.0%
5
  62.5%
3
  20.0%
0
   0.0%
2
  25.0%
5
  45.5%
7
  70.0%
27.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
0
   0.0%
1
  10.0%
0
   0.0%
2
  25.0%
0
   0.0%
2
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
28.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
2
  16.7%
0
   0.0%
0
   0.0%
2
  20.0%
29.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 5 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
0
   0.0%
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
30.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
1
  10.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
31.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
2
  20.0%
32.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
33.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame At any time (Day 7 to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
1
   6.7%
1
   8.3%
0
   0.0%
0
   0.0%
2
  20.0%
LPS
0
   0.0%
1
  10.0%
0
   0.0%
2
  25.0%
1
   6.7%
2
  16.7%
0
   0.0%
0
   0.0%
2
  20.0%
34.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in (Immunoglobulin M) IgM Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
35.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
36.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
1
   9.1%
0
   0.0%
0
   0.0%
2
  20.0%
37.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
   9.1%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
38.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
2
  18.2%
0
   0.0%
0
   0.0%
0
   0.0%
LPS
1
   9.1%
0
   0.0%
0
   0.0%
1
  10.0%
39.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
2
  18.2%
0
   0.0%
0
   0.0%
1
  10.0%
40.Secondary Outcome
Title Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum
Hide Description The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered significant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.
Time Frame At any time (Day 7 to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.
Arm/Group Title Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
2
  13.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
LPS
4
  26.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
41.Secondary Outcome
Title Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC
Hide Description Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
IgA- Invaplex
2
  22.2%
3
  30.0%
6
  60.0%
3
  37.5%
IgA- LPS
4
  44.4%
6
  60.0%
7
  70.0%
6
  75.0%
IgG- Invaplex
3
  33.3%
4
  40.0%
7
  70.0%
6
  75.0%
IgG- LPS
4
  44.4%
2
  20.0%
5
  50.0%
4
  50.0%
42.Secondary Outcome
Title Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC
Hide Description Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 5 0 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
IgA- Invaplex
3
  60.0%
3
  30.0%
4
  50.0%
IgA- LPS
1
  20.0%
4
  40.0%
3
  37.5%
IgG- Invaplex
2
  40.0%
3
  30.0%
5
  62.5%
IgG- LPS
2
  40.0%
1
  10.0%
4
  50.0%
43.Secondary Outcome
Title Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC
Hide Description Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
IgA- Invaplex
2
  33.3%
3
  30.0%
4
  50.0%
IgA- LPS
3
  50.0%
5
  50.0%
3
  37.5%
IgG- Invaplex
1
  16.7%
3
  30.0%
5
  62.5%
IgG- LPS
2
  33.3%
3
  30.0%
4
  50.0%
44.Secondary Outcome
Title Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC
Hide Description Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.
Time Frame At any time (Day 7 to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
IgA- Invaplex
5
  55.6%
3
  30.0%
6
  60.0%
6
  75.0%
IgA- LPS
5
  55.6%
6
  60.0%
9
  90.0%
6
  75.0%
IgG- Invaplex
4
  44.4%
4
  40.0%
7
  70.0%
7
  87.5%
IgG- LPS
4
  44.4%
2
  20.0%
7
  70.0%
5
  62.5%
45.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool
Hide Description The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in enzyme-linked immunosorbent assay (ELISA) assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (Interleukin 1 beta (IL-1β), Interleukin 8 (IL-8), tumor necrosis factor alpha (TNF-α) and Interferon gamma (IFN-γ)) were measured in stool extracts using commercially available ELISA kits.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
  11.1%
3
  30.0%
3
  30.0%
1
  12.5%
2
  13.3%
4
  33.3%
2
  25.0%
4
  36.4%
2
  20.0%
LPS
1
  11.1%
3
  30.0%
1
  10.0%
2
  25.0%
2
  13.3%
3
  25.0%
2
  25.0%
4
  36.4%
3
  30.0%
46.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool
Hide Description The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 9 10 10 8 15 12 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
2
  22.2%
3
  30.0%
2
  20.0%
2
  25.0%
2
  13.3%
3
  25.0%
2
  28.6%
3
  27.3%
3
  30.0%
LPS
2
  22.2%
4
  40.0%
3
  30.0%
2
  25.0%
2
  13.3%
4
  33.3%
2
  28.6%
2
  18.2%
3
  30.0%
47.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool
Hide Description The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 5 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
2
  40.0%
1
  10.0%
2
  25.0%
3
  27.3%
1
  12.5%
2
  18.2%
4
  40.0%
LPS
2
  40.0%
1
  10.0%
2
  25.0%
3
  27.3%
2
  25.0%
3
  27.3%
4
  40.0%
48.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool
Hide Description The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 6 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
1
  16.7%
3
  30.0%
1
  12.5%
1
   9.1%
0
   0.0%
3
  27.3%
3
  30.0%
LPS
1
  16.7%
2
  20.0%
0
   0.0%
2
  18.2%
1
  12.5%
3
  27.3%
4
  40.0%
49.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool
Hide Description The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4
Hide Arm/Group Description:
One or Three oral doses of Placebo
One oral dose of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
One or three oral doses of Placebo
One oral dose of ~3x10^3 cfu WRSS1
Three oral doses of ~3x10^4 cfu WRSS1
Three oral doses of ~3x10^5 cfu WRSS1
Three oral doses of ~3x10^6 cfu WRSS1
Overall Number of Participants Analyzed 5 0 10 8 11 0 8 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Invaplex
3
  60.0%
3
  30.0%
2
  25.0%
2
  18.2%
3
  37.5%
4
  36.4%
3
  30.0%
LPS
1
  20.0%
2
  20.0%
0
   0.0%
3
  27.3%
3
  37.5%
5
  45.5%
3
  30.0%
50.Secondary Outcome
Title Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool
Hide Description The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.
Arm/Group Title Part A (Adults): Placebo Part A (Adults): Cohort A1 Part A (Adults): Cohort A2 Part A (Adults): Cohort A3 Part B (Children): Placebo Part B (Children): Cohort B1 Part B (Children): Cohort B2 Part B (Children): Cohort B3 Part B (Children): Cohort B4