Diarrhea
Conditions
Keywords
ETEC, Escherichia coli, enteric
Brief summary
This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.
Detailed description
This is an open-label clinical trial in which a total of 50 participants will receive three injections of either CssBA alone, dmLT alone or CssBA + dmLT. The vaccine will be administered via IM injection to alternating deltoid regions on days 1, 22, and 43. Each participant will receive the same dose at each vaccination dependent upon group assignment. Group A is considered a pilot group in which all 3 doses will be administered and participants monitored for safety 7 days after the third vaccination, prior to the enrollment of participants in Group B.
Interventions
Sponsors
Naval Medical Research Center
Walter Reed Army Institute of Research (WRAIR)
PATH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment. 2. Completion and review of comprehension test (achieved \> 70% accuracy). 3. Signed informed consent document. 4. Available for the required follow-up period and scheduled clinic visits. 5. Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following last vaccination.
Exclusion criteria
1. Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other condition that might place the subject at increased risk of adverse events) - study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate. 2. Clinically significant abnormalities on physical examination. 3. Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or illness (including immunoglobulin A \[IgA\] deficiency, defined by serum IgA \< 7 mg/dL). 4. Women who are pregnant or planning to become pregnant during the study period plus three (3) months beyond the last received dose and currently nursing women. 5. Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit. 6. Positive blood test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2. 7. Clinically significant abnormalities on basic laboratory screening. 8. Exclusionary skin disease history/findings that would confound assessment or prevent appropriate local monitoring of adverse events (AEs), or possibly increase the risk of a local AE 9. History of chronic skin disease (clinician judgement) 10. Acute skin infection/eruptions on the upper arms including fungal infections, severe acne or active contact dermatitis 11. Allergies that may increase the risk of AEs 12. Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy 13. Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis 14. History of microbiologically confirmed ETEC or cholera infection in the last 3 years 15. Travel to countries where ETEC or V. cholerae or other enteric infections are endemic (most of the developing world) within 3 years prior to dosing (clinician judgement) 16. Symptoms consistent with Travelers' Diarrhea or concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study 17. Vaccination for or ingestion of ETEC, cholera, or E. coli heat labile toxin within 3 years prior to dosing 18. Occupation involving handling of ETEC or V. cholerae currently, or in the past 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Adverse Events | From first vaccination to 28 days after the third vaccination, 71 days. | Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting. Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort Severe (Grade 3): Unable to perform routine activities, significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event |
| Number of Participants With Unsolicited Adverse Events | From first vaccination to 28 days after the third vaccination, 71 days. | Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort Severe (Grade 3): Unable to perform routine activities Significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50 | Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against CS6 at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample. |
| Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50 | Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against labile toxin at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample. |
| Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Days 1, 22, and 43 pre-vaccination, and Day 70 | Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). |
| Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Days 1, 22, and 43 pre-vaccination, and Day 70 | Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). |
| Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Days 1, 22, and 43 pre-vaccination, and Day 70 | Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). |
| Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70 | Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample. |
| Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Days 1, 8, 29 and 50 | Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA. |
| Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Days 1, 8, 29, and 50 | Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA. |
| Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Days 1, 8, 29, and 50 | Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA. |
| Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Days 1, 8, 29, and 50 | Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA. |
| Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Days 1, 22, and 43 pre-vaccination, and Day 70 | Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). |
| Percentage of Participants With a Serum Immunologic Response to Labile Toxin | Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70 | Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample. |
Countries
United States
Participant flow
Recruitment details
Healthy adult men and women, civilian and active-duty military, were recruited from the Baltimore/Washington, DC area through the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) by the use of advertisement in multiple media formats.
Pre-assignment details
Participants were sequentially enrolled to received either recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 vaccine (CssBA) alone, Escherichia coli double mutant heat-labile toxin (dmLT) alone, or CssBA co-administered with dmLT. Participants were to receive 3 vaccinations at the same dose of their assigned treatment. Enrollment of subsequent groups was dependent on safety measured in the first 7 days after the third vaccination of the previous group.
Participants by arm
| Arm | Count |
|---|---|
| Group A1: CssBA 5 µg Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43. | 5 |
| Group A2: DmLT 100 ng Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43. | 5 |
| Group B: CssBA 5 µg + DmLT 100 ng Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43. | 10 |
| Group C: CssBA 5 µg + DmLT 500 ng Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43. | 10 |
| Group D: CssBA 15 µg + DmLT 500 ng Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43. | 10 |
| Group E: CssBA 45 µg + DmLT 500 ng Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43. | 10 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Behavioral Problems | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Inability to Attend Future Visits | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Started a Medication that Precluded Eligibility | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Group A1: CssBA 5 µg | Group A2: DmLT 100 ng | Group B: CssBA 5 µg + DmLT 100 ng | Group C: CssBA 5 µg + DmLT 500 ng | Group D: CssBA 15 µg + DmLT 500 ng | Group E: CssBA 45 µg + DmLT 500 ng | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32 years | 29 years | 29.5 years | 31.5 years | 28 years | 29.5 years | 30 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 9 Participants | 10 Participants | 8 Participants | 9 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 3 Participants | 4 Participants | 23 Participants |
| Race/Ethnicity, Customized Multi-race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 7 Participants | 3 Participants | 7 Participants | 5 Participants | 24 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 5 Participants | 7 Participants | 5 Participants | 7 Participants | 30 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 5 Participants | 3 Participants | 5 Participants | 3 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 5 | 5 / 5 | 10 / 10 | 10 / 10 | 10 / 10 | 10 / 10 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Number of Participants With Solicited Adverse Events
Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting. Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort Severe (Grade 3): Unable to perform routine activities, significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
Time frame: From first vaccination to 28 days after the third vaccination, 71 days.
Population: All participants who received one or more doses of the study drugs
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Number of Participants With Solicited Adverse Events | Mild | 2 Participants |
| Group A1: CssBA 5 µg | Number of Participants With Solicited Adverse Events | Moderate | 0 Participants |
| Group A1: CssBA 5 µg | Number of Participants With Solicited Adverse Events | Severe | 0 Participants |
| Group A1: CssBA 5 µg | Number of Participants With Solicited Adverse Events | Life-threatening | 0 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Solicited Adverse Events | Severe | 0 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Solicited Adverse Events | Moderate | 0 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Solicited Adverse Events | Mild | 5 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Solicited Adverse Events | Life-threatening | 0 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Solicited Adverse Events | Life-threatening | 0 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Solicited Adverse Events | Severe | 0 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Solicited Adverse Events | Moderate | 2 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Solicited Adverse Events | Mild | 9 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Mild | 9 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Life-threatening | 0 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Moderate | 1 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Severe | 0 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Severe | 1 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Life-threatening | 0 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Moderate | 2 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Mild | 10 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Moderate | 2 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Severe | 0 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Life-threatening | 0 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Solicited Adverse Events | Mild | 10 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort Severe (Grade 3): Unable to perform routine activities Significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
Time frame: From first vaccination to 28 days after the third vaccination, 71 days.
Population: All participants who received one or more doses of the study drugs
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Number of Participants With Unsolicited Adverse Events | Mild | 4 Participants |
| Group A1: CssBA 5 µg | Number of Participants With Unsolicited Adverse Events | Moderate | 2 Participants |
| Group A1: CssBA 5 µg | Number of Participants With Unsolicited Adverse Events | Severe | 1 Participants |
| Group A1: CssBA 5 µg | Number of Participants With Unsolicited Adverse Events | Life-threatening | 0 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Severe | 0 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Moderate | 0 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Mild | 3 Participants |
| Group A2: DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Life-threatening | 0 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Life-threatening | 0 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Severe | 1 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Moderate | 2 Participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Number of Participants With Unsolicited Adverse Events | Mild | 5 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Mild | 6 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Life-threatening | 0 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Moderate | 0 Participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Severe | 0 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Severe | 1 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Life-threatening | 0 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Moderate | 1 Participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Mild | 10 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Moderate | 3 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Severe | 2 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Life-threatening | 0 Participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Number of Participants With Unsolicited Adverse Events | Mild | 9 Participants |
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA.
Time frame: Days 1, 8, 29, and 50
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 2.5 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 2.5 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 2.5 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 2.5 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 2.5 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 2.5 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 6.4 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 2.5 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 2.5 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 46.6 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 7.3 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 17.5 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 3.3 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 24.1 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 2.5 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 4.5 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 33.1 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 35.2 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA.
Time frame: Days 1, 8, 29 and 50
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 4.0 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 18.1 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 6.0 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 4.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 4.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 4.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 4.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 4.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 4.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 4.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 5.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 86.7 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 356.9 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 14.9 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 42.9 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 5.7 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 8.5 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 4. titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 29.8 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 238.3 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 142.8 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 4.0 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 7.1 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 47.4 titer |
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA.
Time frame: Days 1, 8, 29, and 50
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available samples at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.0 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 2.0 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 2.0 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 2.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 9.9 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 13.3 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 2.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 3.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 4.1 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 3.6 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.8 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 24.7 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 28.7 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 11.7 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 12.7 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.0 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 19.3 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 23.6 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 8 (7 days after 1st vaccination) | 9.0 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 2.0 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 50 (7 days after 3rd vaccination) | 18.7 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies | Day 29 (7 days after 2nd vacination) | 60.5 titer |
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA.
Time frame: Days 1, 8, 29, and 50
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 2.5 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 2.5 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 2.5 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 13.4 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 2.5 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 88.1 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 70.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 10.0 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 6.6 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 3.5 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 138.4 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 24.0 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 105.8 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 80.7 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 123.3 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 47.4 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 3.1 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 8 (7 days after 1st vaccination) | 17.6 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 29 (7 days after 2nd vacination) | 253.5 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 50 (7 days after 3rd vaccination) | 187.5 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 2.5 titer |
Secondary
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 294.3 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 269.9 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 339.1 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 260.9 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 213.4 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 218.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 215 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 164.7 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 328.7 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 285.1 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 521.6 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 308.5 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 2483.1 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 1571.0 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 846.9 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 330.0 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 408.0 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 368.2 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 505.2 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 970.3 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 523.5 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 370.8 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 2170.4 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 1188.9 titer |
Secondary
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 39.0 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 40.2 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 57.4 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 81.3 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 46.6 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 34.1 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 29.6 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 29.4 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 695.3 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 108.9 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 28.2 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 39.1 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 36.9 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 4631.2 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 81.2 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 513.5 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 288.2 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 2520.4 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 80.1 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 40.5 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 107.1 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 958.3 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 5167.1 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 51.5 titer |
Secondary
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 25.1 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 25.1 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 25.1 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 25.1 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 46.2 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 30.4 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 25.1 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 66.1 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 51.4 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 48.5 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 55.8 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 28.4 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 25.8 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 202.1 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 258.4 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 317.9 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 75.9 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 68.2 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 77.8 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 28.6 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 22 (pre-vaccination) | 134.6 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 43 (pre-vacination) | 159.6 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 70 (28 days after last vaccination) | 121.1 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies | Day 1 (pre-vaccination) | 25.1 titer |
Secondary
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 46.1 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 48.3 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 46.3 titer |
| Group A1: CssBA 5 µg | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 55.0 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 303.7 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 52.8 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 25.1 titer |
| Group A2: DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 398.1 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 424.1 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 235.6 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 172.9 titer |
| Group B: CssBA 5 µg + DmLT 100 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 84.5 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 88.9 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 3114.1 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 1010.3 titer |
| Group C: CssBA 5 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 2671.0 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 679.2 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 1116.9 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 235.0 titer |
| Group D: CssBA 15 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 75.0 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 22 (pre-vaccination) | 193.2 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 43 (pre-vacination) | 666.8 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 70 (28 days after last vaccination) | 1086.4 titer |
| Group E: CssBA 45 µg + DmLT 500 ng | Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies | Day 1 (pre-vaccination) | 48.8 titer |
Secondary
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against CS6 at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Time frame: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 0.0 percentage of participants |
| Group A1: CssBA 5 µg | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 60.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 0.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 0.0 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 33.3 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 100.0 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 88.9 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 88.9 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 80.0 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 100.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 100.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 80.0 percentage of participants |
Secondary
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against labile toxin at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA. A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Time frame: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgA response | 0.0 percentage of participants |
| Group A1: CssBA 5 µg | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgG response | 0.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgA response | 100.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgA response | 22.2 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgA response | 77.8 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgA response | 90.0 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgA response | 100.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |
Secondary
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Time frame: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 0.0 percentage of participants |
| Group A1: CssBA 5 µg | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 20.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 0.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 0.0 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 0.0 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 77.8 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 44.4 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 100.0 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 30.0 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 100.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgA response | 50.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6) | IgG response | 90.0 percentage of participants |
Secondary
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Time frame: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A1: CssBA 5 µg | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgA response | 0.0 percentage of participants |
| Group A1: CssBA 5 µg | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgG response | 0.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgA response | 50.0 percentage of participants |
| Group A2: DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgA response | 22.2 percentage of participants |
| Group B: CssBA 5 µg + DmLT 100 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgG response | 66.7 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgA response | 77.8 percentage of participants |
| Group C: CssBA 5 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgA response | 50.0 percentage of participants |
| Group D: CssBA 15 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgG response | 90.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgA response | 70.0 percentage of participants |
| Group E: CssBA 45 µg + DmLT 500 ng | Percentage of Participants With a Serum Immunologic Response to Labile Toxin | IgG response | 100.0 percentage of participants |