Diarrhea
Conditions
Keywords
shigellosis, Enterobacteriaceae Infections, Gram-Negative Bacterial Infections, Bacterial Infections, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases
Brief summary
This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response. Shigella causes bloody and watery diarrhea, and infants and children living in developing countries experience the greatest consequences of this disease.
Detailed description
The WRSS1 vaccine in will be given to healthy toddlers (12-24 months old). The first vaccination was given to toddlers in the inpatient unit and the second and third doses will be administered on an outpatient basis. A safety evaluation was performed after the first dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose. After the study was initiated, its funder, the Bill and Melinda Gates Foundation (BMGF) made significant changes to the PATH Enteric Vaccine Initiative (EVI) portfolio and decided not to support the three higher-dose cohorts (Cohort 1, 2, and 3) planned as part of this study.
Interventions
BIOLOGICALShigella sonnei Strain WRSS1 Vaccine
Live attenuated, oral Shigella WRSS1 vaccine
BIOLOGICALPlacebo
Sterile saline solution
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
1. Male or female children aged between 12 to 24 month of age at the time of vaccination 2. General good health as determined by the screening evaluation no greater than 30 days before admission 3. Father, mother or other legally acceptable representative (guardian) properly informed about the study, able to understand it and sign the informed consent form 4. Normal bowel habits (\< 3 grade 1 or 2 stools each day; ≥ 1 grade 1 or 2 stools every 2 days) 5. Free of obvious health problems as established by medical history and clinical examination before entering into the study. 6. Parent or guardian available for the entire period of the study and reachable by study staff throughout the entire follow-up period. 7. Signed Informed Consent from the Parent or legal guardian
Exclusion criteria
1. Presence of a significant medical that in the opinion of the Investigator precludes participation in the study 2. Known infection with human immunodeficiency virus (HIV) 3. Presence in the serum of hepatitis A virus (HAV) or hepatitis C virus (HCV) antibody. 4. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder. 5. Participation in research involving another investigational product (defined as receipt of investigational product) 30 days before planned date of first vaccination or concurrently participating in another clinical study, at any time during the study period, in which the child has been or will be exposed to an investigational or a non-investigational product 6. Clinically significant abnormalities on physical examination 7. Clinically significant abnormalities in screening hematology, serum chemistry as determined by the PI or the PI in consultation with the Study Physician 8. History of febrile illness within 48 hours prior to vaccination 9. Known or suspected impairment of immunological function based on medical history and physical examination 10. Prior receipt of any Shigella vaccine 11. Fever at the time of immunization. Fever is defined as a temperature ≥ 37.5C (99.5F) on axillary, oral, or tympanic measurement 12. History of known shigellosis, chronic diarrhea/dysentery in the past 2 months 13. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazol, OTC agents) or immunosuppressive drug 14. Allergy to quinolone, sulfa, and penicillin classes of antibiotics 15. Clinical evidence of active gastrointestinal illness 16. Prior receipt of a blood transfusion or blood products, including immunoglobulins 17. Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol. 18. History of any neurologic disorders or seizures. 19. Acute disease at the time of enrolment 20. Medically significant malnutrition, defined as moderate malnutrition (wt-for-age z-score between -3.0 and -2.0) and severe malnutrition (wt-for-age z-score \<-3.0 or edema) 21. Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives 22. Receipt of antimicrobial drugs for any reason or a fever ≥ 38C within 7 days before vaccination 23. History of diarrhea during the 7 days before vaccination. 24. Has any household member(s) who is immunocompromised or under the age of 1 year old. 25. Culture or polymerase chain reaction (PCR) positive for any Shigella strain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Severity of Reactogenicity by Vaccination | 72 hours after each vaccination (Day 3, Day 31, Day 59) | All toddlers were monitored for evidence of immediate reactions, assessed for systemic reactogenicity (fever, irritability, decreased appetite, and decreased activity) and gastrointestinal (GI) symptoms (abdominal pain, nausea, vomiting, loose stool, diarrhea, dysentery, bloating, excess flatulence, constipation) during the 72 hours following each vaccine dose. |
| Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Up to 28 days after any vaccination (up to Day 84) | All toddlers were monitored for the occurrence of any adverse event (AE) or serious adverse event (SAE). Toddlers visited the clinic for safety assessments approximately one month after each vaccination. Grades are based on maximum severity per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Days 0, 7, 35, and 63 | The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei lipopolysaccharide (LPS) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants from cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgA response from circulating lymphocytes. |
| Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Days 0, 7, 35, and 63 | The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgG response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC. |
| Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Days 0, 7, 35, and 63 | The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgG response from circulating lymphocytes. |
| Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Days 0, 7, 35, and 63 | The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgM response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC. |
| Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Days 0, 7, 35, and 63 | The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgM response from circulating lymphocytes. |
| Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Days 7, 35, and 63 | — |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Days 0, 7, 35, and 63 | The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the enzyme-linked immunosorbent assay (ELISA) plates. |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Days 0, 7, 35, and 63 | The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific lipopolysaccharide (LPS) from the Walter Reed Army Institute was used to coat the ELISA plates. |
| Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Days 0, 7, 35, and 63 | The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. |
| Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Days 0, 7, 35, and 63 | The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. |
| Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Days 0, 7, 35, and 63 | The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. |
| Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Days 0, 7, 35, and 63 | The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates. |
| Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Days 7, 35, and 63 | — |
| Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Days 7, 35, and 63 | — |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Days 0, 7, 28, 35, 56, 63, and 84 | The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei Invaplex in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Days 7, 28, 35, 56, 63, and 84 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84 | — |
| Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84 | — |
| Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Days 7, 28, 35, 56, 63, and 84 | — |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Days 0, 7, 28, 35, 56, 63, and 84 | The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei LPS in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84. |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Days 0, 7, 35, and 63 | The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgA response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC. |
Countries
Bangladesh
Participant flow
Recruitment details
This was a single-site study conducted in Bangladesh. The study originally planned to enroll up to 64 toddlers to receive three doses of 3x10\^3, 3x10\^4, 3x10\^5 or 3x10\^6 colony-forming units (CFU) live attenuated, oral shigella WRSS1 vaccine or placebo, however enrollment was terminated after the first dose cohort was enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: WRSS1 Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart. | 12 |
| Cohort 1: Placebo Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart. | 4 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Received Vaccination 2 | Death | 0 | 1 |
| Received Vaccination 3 | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: WRSS1 | Cohort 1: Placebo | Total |
|---|---|---|---|
| Age, Continuous | 17.4 months STANDARD_DEVIATION 3.03 | 16.0 months STANDARD_DEVIATION 1.41 | 17.1 months STANDARD_DEVIATION 2.74 |
| Height | 76.0 cm STANDARD_DEVIATION 4.01 | 74.0 cm STANDARD_DEVIATION 2.16 | 75.5 cm STANDARD_DEVIATION 3.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
| Weight | 9.6 kilograms STANDARD_DEVIATION 0.92 | 9.0 kilograms STANDARD_DEVIATION 0.34 | 9.4 kilograms STANDARD_DEVIATION 0.85 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 1 / 4 |
| other Total, other adverse events | 11 / 12 | 4 / 4 |
| serious Total, serious adverse events | 0 / 12 | 1 / 4 |
Outcome results
Primary
Maximum Severity of Reactogenicity by Vaccination
All toddlers were monitored for evidence of immediate reactions, assessed for systemic reactogenicity (fever, irritability, decreased appetite, and decreased activity) and gastrointestinal (GI) symptoms (abdominal pain, nausea, vomiting, loose stool, diarrhea, dysentery, bloating, excess flatulence, constipation) during the 72 hours following each vaccine dose.
Time frame: 72 hours after each vaccination (Day 3, Day 31, Day 59)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Vomiting | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Mild | 5 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Fever | None | 11 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Loose stool | None | 7 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Fever | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Mild | 1 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Irritability | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | None | 11 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Irritability | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Fever | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Dysentery | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Irritability | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Bloating | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Bloating | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Nausea | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Bloating | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Bloating | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Nausea | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Bloating | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Irritability | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Nausea | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Fever | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Nausea | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Irritability | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Nausea | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Constipation | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Constipation | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Constipation | Severe | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Mild | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Constipation | Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Moderate | 0 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Constipation | None | 12 Participants |
| Cohort 1: WRSS1 | Maximum Severity of Reactogenicity by Vaccination | Fever | Mild | 1 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Constipation | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Fever | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Fever | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Fever | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Fever | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Fever | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased appetite | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Irritability | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Irritability | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Irritability | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Irritability | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Irritability | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Decreased activity | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Mild | 1 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Abdominal pain | None | 3 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Nausea | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Nausea | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Nausea | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Nausea | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Nausea | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Vomiting | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Vomiting | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Loose stool | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Loose stool | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Mild | 1 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Diarrhea | None | 3 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Dysentery | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Dysentery | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Bloating | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Bloating | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Bloating | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Bloating | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Excess flatulence | None | 4 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Constipation | Mild | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Constipation | Moderate | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Constipation | Severe | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Constipation | Life Threatening | 0 Participants |
| Cohort 1: Placebo | Maximum Severity of Reactogenicity by Vaccination | Bloating | Mild | 0 Participants |
Primary
Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity
All toddlers were monitored for the occurrence of any adverse event (AE) or serious adverse event (SAE). Toddlers visited the clinic for safety assessments approximately one month after each vaccination. Grades are based on maximum severity per participant.
Time frame: Up to 28 days after any vaccination (up to Day 84)
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Mild | 5 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Moderate | 6 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Severe | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Death | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Total | 11 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Mild | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Moderate | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Severe | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Life Threatening | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Death | 0 Participants |
| Cohort 1: WRSS1 | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Total | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Death | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Mild | 3 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Mild | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Moderate | 1 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Life Threatening | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Severe | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Moderate | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Life Threatening | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Total | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Death | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | AEs related to study vaccine: Severe | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity | Any adverse events: Total | 4 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | Less than 4-fold rise | 5 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | Less than 4-fold rise | 8 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | Less than 4-fold rise | 7 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | Less than 4-fold rise | 9 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | Less than 4-fold rise | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | Less than 4-fold rise | 2 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 8 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 10 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 2 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
Time frame: Days 7, 28, 35, 56, 63, and 84
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 4-fold rise or higher | 3 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | Less than 4-fold rise | 7 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 28 | 4-fold rise or higher | 4 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 28 | Less than 4-fold rise | 6 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 35 | 4-fold rise or higher | 3 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 35 | Less than 4-fold rise | 7 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 56 | 4-fold rise or higher | 4 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 56 | Less than 4-fold rise | 7 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 63 | 4-fold rise or higher | 4 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 63 | Less than 4-fold rise | 7 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 84 | 4-fold rise or higher | 3 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 84 | Less than 4-fold rise | 7 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | At any time | 4-fold rise or higher | 6 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | At any time | Less than 4-fold rise | 5 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 84 | 4-fold rise or higher | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 56 | Less than 4-fold rise | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 28 | 4-fold rise or higher | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 63 | 4-fold rise or higher | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 28 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 84 | Less than 4-fold rise | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 35 | 4-fold rise or higher | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 63 | Less than 4-fold rise | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 35 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | At any time | Less than 4-fold rise | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 56 | 4-fold rise or higher | 2 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Time frame: Days 7, 28, 35, 56, 63, and 84
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 4 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 6 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | 4-fold rise or higher | 5 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | Less than 4-fold rise | 5 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 8 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | 4-fold rise or higher | 3 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | Less than 4-fold rise | 8 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 3 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 8 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | 4-fold rise or higher | 4 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | Less than 4-fold rise | 6 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 6 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 5 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | Less than 4-fold rise | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | 4-fold rise or higher | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 1 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | 4-fold rise or higher | 1 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | Less than 4-fold rise | 9 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 9 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | Less than 4-fold rise | 9 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 8 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 8 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | Less than 4-fold rise | 9 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 9 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | 4-fold rise or higher | 3 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | Less than 4-fold rise | 8 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 4 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 7 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 4 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 7 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | 4-fold rise or higher | 2 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | Less than 4-fold rise | 9 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | 4-fold rise or higher | 2 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
Secondary
Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen
Time frame: Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 11 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 10 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 1 Participants |
| Cohort 1: WRSS1 | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 10 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 7 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | At any time | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | 4-fold rise or higher | 0 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 63 | Less than 4-fold rise | 3 Participants |
| Cohort 1: Placebo | Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen | Day 35 | Less than 4-fold rise | 3 Participants |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 7 | 1.01 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 35 | 0.77 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 63 | 0.79 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 7 | 0.98 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 35 | 1.00 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 63 | 0.96 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 1.00 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 1.03 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 1.39 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 1.10 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 1.07 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 1.04 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 7 | 0.97 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 35 | 0.95 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 63 | 2.18 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 7 | 0.84 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 35 | 0.98 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 63 | 1.08 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 1.05 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 0.94 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 3.18 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 0.90 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 5.47 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 5.19 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 7 | 1.88 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 28 | 2.27 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 35 | 1.74 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 56 | 1.44 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 63 | 1.85 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 84 | 1.25 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 63 | 3.12 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 7 | 1.37 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 56 | 14.69 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 28 | 2.58 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 84 | 1.10 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens | Day 35 | 1.28 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 1.84 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | 1.64 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | 1.24 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | 1.14 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | 1.11 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | 0.95 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | 2.27 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 0.72 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | 9.19 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | 1.90 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | 0.53 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | 0.36 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 1.45 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.93 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 1.38 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 1.32 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.73 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 0.82 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 7 | 1.48 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 35 | 1.04 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 63 | 1.58 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 63 | 1.04 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 7 | 1.00 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 35 | 1.07 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 0.06 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 35 | 2.19 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 63 | 0.45 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 0.87 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 35 | 1.26 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 63 | 1.55 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 7 | 0.13 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 35 | 2.98 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 63 | 0.93 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 7 | 0.16 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 35 | 1.03 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 63 | 1.06 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 1.64 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.98 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 1.39 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 0.90 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.78 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 0.87 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 1.83 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 1.12 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 1.58 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 0.91 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 0.93 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 1.18 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen | Day 7 | 1.48 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen | Day 35 | 1.58 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen | Day 63 | 1.74 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen | Day 7 | 1.09 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen | Day 35 | 1.68 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen | Day 63 | 1.86 fold change |
Secondary
Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Time frame: Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 1.43 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 1.14 fold change |
| Cohort 1: WRSS1 | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 1.74 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 1.09 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 1.62 fold change |
| Cohort 1: Placebo | Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 1.37 fold change |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens
The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgA response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 0 | 0.09 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 7 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 35 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 63 | 0.07 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 63 | 0.07 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 0 | 0.07 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 35 | 0.07 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens | Day 7 | 0.06 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei lipopolysaccharide (LPS) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants from cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgA response from circulating lymphocytes.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 0 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 0.09 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 0.06 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 0 | 0.06 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 0.07 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 0.07 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens
The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the enzyme-linked immunosorbent assay (ELISA) plates.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 0 | 0.17 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 7 | 0.17 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 35 | 0.16 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 63 | 0.36 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 63 | 0.13 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 0 | 0.12 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 35 | 0.12 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens | Day 7 | 0.10 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific lipopolysaccharide (LPS) from the Walter Reed Army Institute was used to coat the ELISA plates.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 0 | 0.10 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 0.11 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 0.09 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 0.32 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 0.54 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 0 | 0.10 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 0.57 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 0.09 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei Invaplex in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC.
Time frame: Days 0, 7, 28, 35, 56, 63, and 84
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 28 | 1.61 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 56 | 1.12 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 1.74 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 63 | 1.44 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 35 | 1.59 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 84 | 0.95 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 0 | 0.78 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 84 | 0.52 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 0 | 0.48 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 0.65 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 28 | 1.23 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 35 | 0.61 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 56 | 1.77 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 63 | 1.48 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei LPS in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84.
Time frame: Days 0, 7, 28, 35, 56, 63, and 84
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | 2.99 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | 2.08 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 3.43 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | 2.05 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | 3.00 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | 1.89 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 0 | 1.85 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 84 | 0.43 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 0 | 0.80 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 0.58 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 28 | 1.53 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 35 | 0.29 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 56 | 3.51 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 63 | 1.82 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgG response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 0 | 0.10 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 0.15 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.09 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 0.14 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 0.12 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 0 | 0.15 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.11 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 0.19 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)
The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgG response from circulating lymphocytes.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 0 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 7 | 0.10 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 35 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 63 | 0.11 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 63 | 0.08 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 0 | 0.08 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 35 | 0.08 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) | Day 7 | 0.08 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 0 | 66.79 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 3.76 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 35 | 146.08 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 63 | 29.44 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 63 | 147.73 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 0 | 95.23 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 35 | 119.79 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 82.78 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)
The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 7 | 0.68 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 0 | 5.02 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 35 | 14.97 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 63 | 4.63 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 63 | 1.06 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 35 | 1.03 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 0 | 1.00 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) | Day 7 | 0.16 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen
The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgM response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 0 | 0.08 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 0.14 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.08 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 0.12 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 63 | 0.09 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 0 | 0.10 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 35 | 0.08 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen | Day 7 | 0.09 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen
The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgM response from circulating lymphocytes.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 0 | 0.07 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 0.13 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 0.08 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 0.11 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 63 | 0.11 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 0 | 0.09 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 35 | 0.09 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen | Day 7 | 0.08 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen
The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 0 | 119.55 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 7 | 177.34 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 35 | 188.41 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 63 | 208.53 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 63 | 198.66 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 0 | 107.03 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 35 | 180.28 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen | Day 7 | 116.79 titer |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.
Time frame: Days 0, 7, 35, and 63
Population: Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 0 | 102.80 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 146.48 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 117.25 titer |
| Cohort 1: WRSS1 | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 179.07 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 63 | 148.62 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 0 | 108.10 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 35 | 174.98 titer |
| Cohort 1: Placebo | Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 117.38 titer |