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This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC). Sf2aWC is a killed vaccine that is being made to prevent disease from Shigella., which causes bloody, watery diarrhea. Infants and children living in developing countries experience the greatest consequences of this disease. The purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops an immune response. About 82 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights for the first dose. Participants in Cohorts 2, 3, and 4 will not be required to stay overnight for the second and third doses. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples and documenting side effects. Participants will be involved in study related procedures for about 8 months.
Despite the public health burden of Shigella spp. on travelers, deployed soldiers and, most significantly, young children in the developing world, there is no licensed vaccine against Shigella. The rationale for using Shigella flexneri 2a whole cell killed vaccine (Sf2aWC), is that it is expected to be especially well tolerated by subjects. If Sf2aWC is safe and immunogenic, it may be combined with S. sonnei and S. flexneri 3a as the basis of a multivalent vaccine, because these three components should cover up to 80% of shigella infections in developing countries and over 90% in developed countries. This is a single site, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study in healthy adult subjects. Approximately 82 subjects will be enrolled into four separate cohorts and will be randomized to receive Sf2aWC or placebo. The placebo preparation will be bicarbonate buffer. Cohort 1 subjects will receive a single oral dose of Sf2aWC (2.6±0.8 x 10^8 vp/mL) or placebo. Dosing and 72 hours of supervised post-vaccination safety follow-up will be conducted in the Center for Immunization Research, Johns Hopkins School of Public Health (CIR) Inpatient Unit. Before enrolling subjects in subsequent cohorts, safety data from the previous Cohort(s) through Study Day 7 will be evaluated and reviewed by the Safety Review Committee (SRC). Cohorts 2, 3, and 4 participants will receive three doses of Sf2aWC vaccine or placebo at 0, 1 and 2 months. The first immunization will be administered in the CIR inpatient unit, followed by 72 hours of direct post-immunization observation. If after review by the SRC the first dose appears safe and well tolerated, subsequent doses will be administered on an outpatient basis. Safety will be assessed by solicited symptoms/subject memory aid and laboratory evaluations. Adverse events (AE)s will be graded according to standardized criteria. The immunogenicity outcome measures of interest include serum immunoglobulin G (IgG) and immunoglobulin A (IgA) antibodies by ELISA against S. flexneri 2a Lipopolysaccharide (LPS) and S. flexneri 2a invasive protein antigens (Ipa), cytokine assays, B and T cell memory responses, and vaccine-specific IgA responses. The proposed sample size of twenty per group in Cohorts 2, 3, and 4 would be sufficient to select the appropriate dose to move into the next study phase, providing that a difference in the immunogenicity between the two arms is 20% or greater. Participants will include 82 healthy adult male and female subjects, ages 18 to 45 inclusive. The primary objective of this study is to assess the safety and tolerability of Sf2aWC vaccine when administered in three oral doses over a range of dose levels in healthy adult subjects. The secondary objective is to assess the immunogenicity of the Sf2aWC vaccine over a range of doses in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) |
|
| Cohort 2 | Experimental | Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) |
|
| Cohort 3 | Experimental | Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) |
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| Cohort 4 | Experimental | Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) |
|
| Placebo | Placebo Comparator | Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose | Biological | Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Reactogenicity Per Subject and Treatment Group | Local and systemic reactogenicity was assessed post-vaccination using targeted physical examinations, vital signs and clinical laboratory tests, and diary cards (completed following discharge daily through Day 7). Reactogenicity included: nausea, vomiting, fever, abdominal pain, abdominal cramping, bloating, malaise, headache, decreased appetite, generalized myalgias, chills, light-headedness, constipation, excessive flatulence, reactive arthritis, dysentery, loose stool, diarrhea, hypovolemia, joint pain, defecation urgency, and oral temperature. | 7 days after each vaccination (Day 0, Day 35, Day 63) |
| Frequency of Unsolicited Adverse Events With a Reasonable Possibility That the Study Product Caused the Event | 6 months after final vaccination (Day 168 or Day 224) |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton D Harro, MD, ScM | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Immunization Research (CIR) at Johns Hopkins School of Public Health (JHSPH) | Baltimore | Maryland | 21224 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26865592 | Result | Chakraborty S, Harro C, DeNearing B, Bream J, Bauers N, Dally L, Flores J, Van de Verg L, Sack DA, Walker R. Evaluation of the Safety, Tolerability, and Immunogenicity of an Oral, Inactivated Whole-Cell Shigella flexneri 2a Vaccine in Healthy Adult Subjects. Clin Vaccine Immunol. 2016 Apr 4;23(4):315-25. doi: 10.1128/CVI.00608-15. Print 2016 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0 |
| FG001 | Cohort 2 | Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56 |
| FG002 | Cohort 3 | Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56 |
| FG003 | Cohort 4 | Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56 |
| FG004 | Placebo | Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses). Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Received Vaccination 1 |
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| Received Vaccination 2 |
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| Received Vaccination 3 |
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One subject in Cohort 3 was randomized in error and did not receive the study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0 |
| BG001 | Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Reactogenicity Per Subject and Treatment Group | Local and systemic reactogenicity was assessed post-vaccination using targeted physical examinations, vital signs and clinical laboratory tests, and diary cards (completed following discharge daily through Day 7). Reactogenicity included: nausea, vomiting, fever, abdominal pain, abdominal cramping, bloating, malaise, headache, decreased appetite, generalized myalgias, chills, light-headedness, constipation, excessive flatulence, reactive arthritis, dysentery, loose stool, diarrhea, hypovolemia, joint pain, defecation urgency, and oral temperature. | Number may differ from overall number of participants analyzed if vaccination was not received. | Posted | Count of Participants | Participants | 7 days after each vaccination (Day 0, Day 35, Day 63) |
|
6 months after final vaccination (Day 168 for Cohort 1, or Day 224 for Cohort 2, 3, and 4)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Received one oral dose of 2.6±0.8 x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores | PATH | (202) 822-0033 | jeflores@path.org |
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| ID | Term |
|---|---|
| D004405 | Dysentery, Bacillary |
| D004403 | Dysentery |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses | Biological | Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56 |
|
| Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses | Biological | Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56 |
|
| Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses | Biological | Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56 |
|
| Placebo: 1-3 doses | Biological | Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses) |
|
| 35 days |
| Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 63 days |
| Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 3 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 35 days |
| Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 63 days |
| Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 16 weeks |
| Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 16 weeks |
| Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 3 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 35 days |
| Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 16 weeks |
| Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 63 days |
| Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 63 days |
| Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 63 days |
| Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 63 days |
| Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 63 days |
| Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 63 days |
| Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 63 days |
| Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 63 days |
| Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 16 weeks |
| Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3 | Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 16 weeks |
| Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 16 weeks |
| Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3 | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 16 weeks |
| Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 63 days |
| Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 4 | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 63 days |
| Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | 63 days |
| Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 4 | Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | 63 days |
| Johns Hopkins University CIR Isolation Unit |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56 |
| BG002 | Cohort 3 | Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56 |
| BG003 | Cohort 4 | Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56 |
| BG004 | Placebo | Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses). Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses) |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cohort 2 | Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56 |
| OG002 | Cohort 3 | Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56 |
| OG003 | Cohort 4 | Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56 |
|
|
| Primary | Frequency of Unsolicited Adverse Events With a Reasonable Possibility That the Study Product Caused the Event | Posted | Number | adverse events | 6 months after final vaccination (Day 168 or Day 224) |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 35 days |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 3 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 35 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 63 days |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 3 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 35 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4 | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 16 weeks |
|
|
|
| Secondary | Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 63 days |
|
|
|
| Secondary | Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response | S. flexneri 2a LPS were used as the ELISA antigens. Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 63 days |
|
|
|
| Secondary | Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 63 days |
|
|
|
| Secondary | Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 63 days |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3 | Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 16 weeks |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3 | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 16 weeks |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 4 | Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant). Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Geometric Mean | 95% Confidence Interval | titer | 63 days |
|
|
|
| Secondary | Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline | A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place). For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14). Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 4 | Immunogenicity responses are presented for Cohorts 3 and 4 only. Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected. For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14. | Results were included for subjects that received each vaccination and with usable samples. | Posted | Mean | 95% Confidence Interval | titer | 63 days |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Cohort 2 | Received three oral doses of 2.6±0.8 x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56 | 0 | 20 | 0 | 20 | 8 | 20 |
| EG002 | Cohort 3 | Received three oral doses of 2.6±0.8 x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56 | 0 | 20 | 0 | 20 | 15 | 20 |
| EG003 | Cohort 4 | Received three oral doses of 2.6±0.8 x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC) Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses: Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56 | 0 | 20 | 0 | 20 | 13 | 20 |
| EG004 | Placebo | Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses). Placebo: 1-3 doses: Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses) | 0 | 17 | 0 | 17 | 11 | 17 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle strain | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Eosinophil count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vaginal infection | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| Mild |
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Total |
|
| No |
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 2 (Day 28) |
|
| Day 35 |
|
| Pre-vaccination 3 (Day 56) |
|
| Day 63 |
|
| Day 7 |
|
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 2 (Day 28) |
|
| Day 35 |
|
| Pre-vaccination 3 (Day 56) |
|
| Day 63 |
|
| No |
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| No |
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
| Week 16 |
|
|
| Day 7 |
|
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 2 (Day 28) |
|
| Day 35 |
|
| Pre-vaccination 3 (Day 56) |
|
| Day 63 |
|
| Week 16 |
|
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
|
| Day 7 |
|
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
| No |
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
| Day 7 |
|
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
| No |
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
| Day 7 |
|
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
| Pre-vaccination 2 (Day 28) |
|
| Day 35 |
|
| Pre-vaccination 3 (Day 56) |
|
| Day 63 |
|
| Day 7 |
|
|
| Pre-vaccination 2 (Day 28) |
|
|
| Day 35 |
|
|
| Pre-vaccination 3 (Day 56) |
|
|
| Day 63 |
|
|
| No |
|
| Day 35 |
|
|
| Day 63 |
|
|
| Week 16 |
|
|
| Day 7 |
|
|
| Day 35 |
|
|
| Day 63 |
|
|
| Week 16 |
|
|
| No |
|
| Day 35 |
|
|
| Day 63 |
|
|
| Week 16 |
|
|
| Day 7 |
|
|
| Day 35 |
|
|
| Day 63 |
|
|
| Week 16 |
|
|
| No |
|
| Day 35 |
|
|
| Day 63 |
|
|
| Day 7 |
|
|
| Day 35 |
|
|
| Day 63 |
|
|
| No |
|
| Day 35 |
|
|
| Day 63 |
|
|
| Day 7 |
|
|
| Day 35 |
|
|
| Day 63 |
|
|
| No |
|
| No |
|
| No |
|
| No |
|