Trial Outcomes & Findings for Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC) (NCT NCT03404674)
NCT ID: NCT03404674
Last Updated: 2021-01-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
From first vaccination to 28 days after the third vaccination, 71 days.
Results posted on
2021-01-06
Participant Flow
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.
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.
Participant milestones
| Measure |
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
10
|
10
|
10
|
10
|
|
Overall Study
Received Dose 2
|
5
|
4
|
10
|
9
|
10
|
10
|
|
Overall Study
Received Dose 3
|
5
|
4
|
9
|
9
|
10
|
9
|
|
Overall Study
COMPLETED
|
5
|
4
|
8
|
9
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Inability to Attend Future Visits
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Behavioral Problems
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Started a Medication that Precluded Eligibility
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
Baseline characteristics by cohort
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=5 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=10 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
29 years
n=7 Participants
|
29.5 years
n=5 Participants
|
31.5 years
n=4 Participants
|
28 years
n=21 Participants
|
29.5 years
n=10 Participants
|
30 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Multi-race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
10 participants
n=10 Participants
|
10 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=5 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=10 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events
Mild
|
2 Participants
|
5 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events
Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events
Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=5 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=10 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
Mild
|
4 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Moderate
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
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.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
IgA response
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
44.4 percentage of participants
|
30.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
IgG response
|
20.0 percentage of participants
|
0.0 percentage of participants
|
77.8 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
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.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
IgA response
|
0.0 percentage of participants
|
50.0 percentage of participants
|
22.2 percentage of participants
|
77.8 percentage of participants
|
50.0 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
IgG response
|
0.0 percentage of participants
|
100.0 percentage of participants
|
66.7 percentage of participants
|
100.0 percentage of participants
|
90.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
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.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
IgA response
|
0.0 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
88.9 percentage of participants
|
80.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
IgG response
|
60.0 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
88.9 percentage of participants
|
100.0 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50Population: Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
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.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
IgA response
|
0.0 percentage of participants
|
100.0 percentage of participants
|
22.2 percentage of participants
|
77.8 percentage of participants
|
90.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
IgG response
|
0.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1, 22, and 43 pre-vaccination, and Day 70Population: 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.
Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Day 1 (pre-vaccination)
|
39.0 titer
Interval 18.2 to 83.6
|
29.6 titer
Interval 17.5 to 50.1
|
39.1 titer
Interval 22.2 to 69.1
|
36.9 titer
Interval 20.5 to 66.6
|
40.5 titer
Interval 24.6 to 66.7
|
51.5 titer
Interval 26.1 to 101.4
|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Day 22 (pre-vaccination)
|
40.2 titer
Interval 17.8 to 90.8
|
34.1 titer
Interval 12.9 to 90.7
|
28.2 titer
Interval 21.6 to 36.8
|
81.2 titer
Interval 16.6 to 396.6
|
80.1 titer
Interval 39.4 to 162.9
|
107.1 titer
Interval 28.3 to 405.7
|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Day 43 (pre-vacination)
|
57.4 titer
Interval 16.9 to 195.0
|
46.6 titer
Interval 14.5 to 149.8
|
108.9 titer
Interval 54.3 to 218.4
|
513.5 titer
Interval 77.2 to 3415.4
|
288.2 titer
Interval 100.2 to 829.2
|
958.3 titer
Interval 235.9 to 3893.4
|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Day 70 (28 days after last vaccination)
|
81.3 titer
Interval 19.0 to 346.7
|
29.4 titer
Interval 17.8 to 48.5
|
695.3 titer
Interval 182.1 to 2655.3
|
4631.2 titer
Interval 1462.3 to 14667.6
|
2520.4 titer
Interval 1199.2 to 5297.2
|
5167.1 titer
Interval 1298.8 to 20556.8
|
SECONDARY outcome
Timeframe: Days 1, 22, and 43 pre-vaccination, and Day 70Population: 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.
Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Day 70 (28 days after last vaccination)
|
339.1 titer
Interval 143.6 to 800.6
|
218.0 titer
Interval 48.4 to 982.4
|
521.6 titer
Interval 236.5 to 1150.3
|
2483.1 titer
Interval 595.3 to 10357.2
|
970.3 titer
Interval 553.4 to 1701.4
|
2170.4 titer
Interval 1053.0 to 4473.7
|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Day 1 (pre-vaccination)
|
269.9 titer
Interval 133.6 to 545.1
|
213.4 titer
Interval 73.0 to 623.6
|
308.5 titer
Interval 181.4 to 524.4
|
330.0 titer
Interval 176.1 to 618.6
|
368.2 titer
Interval 192.3 to 705.0
|
370.8 titer
Interval 180.9 to 760.0
|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Day 22 (pre-vaccination)
|
294.3 titer
Interval 128.7 to 672.9
|
215 titer
Interval 64.9 to 712.4
|
285.1 titer
Interval 172.9 to 469.9
|
846.9 titer
Interval 189.1 to 3792.6
|
408.0 titer
Interval 223.1 to 746.1
|
523.5 titer
Interval 262.0 to 1045.9
|
|
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Day 43 (pre-vacination)
|
260.9 titer
Interval 122.0 to 557.8
|
164.7 titer
Interval 47.5 to 571.3
|
328.7 titer
Interval 200.5 to 538.8
|
1571.0 titer
Interval 341.7 to 7222.1
|
505.2 titer
Interval 275.8 to 925.4
|
1188.9 titer
Interval 515.4 to 2742.6
|
SECONDARY outcome
Timeframe: Days 1, 22, and 43 pre-vaccination, and Day 70Population: 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.
Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Day 1 (pre-vaccination)
|
46.1 titer
Interval 16.4 to 129.7
|
25.1 titer
Confidence interval could not be calculated as the variance was zero
|
84.5 titer
Interval 31.8 to 224.0
|
88.9 titer
Interval 54.0 to 146.5
|
75.0 titer
Interval 37.4 to 150.4
|
48.8 titer
Interval 25.0 to 95.2
|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Day 22 (pre-vaccination)
|
48.3 titer
Interval 15.3 to 152.1
|
52.8 titer
Interval 11.4 to 243.9
|
172.9 titer
Interval 42.4 to 705.5
|
1010.3 titer
Interval 182.9 to 5579.8
|
235.0 titer
Interval 64.1 to 860.7
|
193.2 titer
Interval 80.0 to 466.6
|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Day 43 (pre-vacination)
|
46.3 titer
Interval 15.8 to 136.0
|
303.7 titer
Interval 39.8 to 2316.2
|
235.6 titer
Interval 67.5 to 822.0
|
2671.0 titer
Interval 754.2 to 9459.1
|
679.2 titer
Interval 256.7 to 1797.0
|
666.8 titer
Interval 339.7 to 1308.9
|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Day 70 (28 days after last vaccination)
|
55.0 titer
Interval 17.8 to 170.1
|
398.1 titer
Interval 91.9 to 1724.3
|
424.1 titer
Interval 159.7 to 1126.6
|
3114.1 titer
Interval 965.3 to 10046.6
|
1116.9 titer
Interval 467.8 to 2666.7
|
1086.4 titer
Interval 473.8 to 2491.2
|
SECONDARY outcome
Timeframe: Days 1, 22, and 43 pre-vaccination, and Day 70Population: 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.
Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Day 1 (pre-vaccination)
|
25.1 titer
Confidence interval could not be calculated as the variance was zero
|
25.1 titer
Confidence interval could not be calculated as the variance was zero
|
28.4 titer
Interval 21.4 to 37.7
|
25.8 titer
Interval 24.2 to 27.6
|
28.6 titer
Interval 21.3 to 38.5
|
25.1 titer
Confidence interval could not be calculated as the variance was zero
|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Day 22 (pre-vaccination)
|
25.1 titer
Confidence interval could not be calculated as the variance was zero
|
30.4 titer
Interval 16.6 to 55.6
|
55.8 titer
Interval 24.6 to 126.5
|
258.4 titer
Interval 49.3 to 1352.9
|
77.8 titer
Interval 35.3 to 171.3
|
134.6 titer
Interval 57.0 to 317.6
|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Day 43 (pre-vacination)
|
25.1 titer
Confidence interval could not be calculated as the variance was zero
|
46.2 titer
Interval 9.0 to 238.3
|
48.5 titer
Interval 22.0 to 107.0
|
317.9 titer
Interval 72.8 to 1388.5
|
75.9 titer
Interval 33.6 to 171.4
|
159.6 titer
Interval 62.8 to 405.3
|
|
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Day 70 (28 days after last vaccination)
|
25.1 titer
Confidence interval could not be calculated as the variance was zero
|
66.1 titer
Interval 10.6 to 410.1
|
51.4 titer
Interval 20.9 to 126.4
|
202.1 titer
Interval 43.8 to 932.2
|
68.2 titer
Interval 29.9 to 155.6
|
121.1 titer
Interval 57.2 to 256.1
|
SECONDARY outcome
Timeframe: Days 1, 8, 29 and 50Population: 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.
Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=8 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Day 1 (pre-vaccination)
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
5.7 titer
Interval 2.5 to 12.8
|
4. titer
Confidence interval could not be calculated as the variance was zero
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Day 8 (7 days after 1st vaccination)
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
5.0 titer
Interval 2.9 to 8.6
|
14.9 titer
Interval 3.2 to 70.3
|
8.5 titer
Interval 2.7 to 26.6
|
7.1 titer
Interval 3.0 to 17.0
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Day 29 (7 days after 2nd vacination)
|
6.0 titer
Interval 2.0 to 18.4
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
42.9 titer
Interval 10.7 to 172.0
|
29.8 titer
Interval 8.2 to 108.6
|
47.4 titer
Interval 12.7 to 176.5
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Day 50 (7 days after 3rd vaccination)
|
18.1 titer
Interval 3.1 to 106.4
|
4.0 titer
Confidence interval could not be calculated as the variance was zero
|
86.7 titer
Interval 43.1 to 174.4
|
356.9 titer
Interval 208.5 to 610.7
|
238.3 titer
Interval 115.3 to 492.3
|
142.8 titer
Interval 32.2 to 633.2
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 50Population: 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.
Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Day 1 (pre-vaccination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Interval 2.5 to 2.5
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Day 8 (7 days after 1st vaccination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
7.3 titer
Interval 1.3 to 42.2
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
4.5 titer
Interval 1.9 to 10.8
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Day 29 (7 days after 2nd vacination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
17.5 titer
Interval 4.0 to 76.0
|
3.3 titer
Interval 1.8 to 6.0
|
33.1 titer
Interval 14.7 to 74.3
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Day 50 (7 days after 3rd vaccination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
6.4 titer
Interval 2.1 to 19.6
|
46.6 titer
Interval 13.8 to 157.2
|
24.1 titer
Interval 8.5 to 68.7
|
35.2 titer
Interval 17.4 to 71.0
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 50Population: 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.
Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=8 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Day 1 (pre-vaccination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
3.5 titer
Interval 1.6 to 7.8
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
3.1 titer
Interval 2.0 to 4.8
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Day 8 (7 days after 1st vaccination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
6.6 titer
Interval 1.5 to 29.2
|
24.0 titer
Interval 6.0 to 97.0
|
47.4 titer
Interval 8.7 to 258.8
|
17.6 titer
Interval 5.0 to 61.4
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Day 29 (7 days after 2nd vacination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
13.4 titer
Interval 0.6 to 305.9
|
10.0 titer
Interval 2.0 to 49.9
|
105.8 titer
Interval 60.7 to 184.3
|
80.7 titer
Interval 50.2 to 129.9
|
253.5 titer
Interval 116.5 to 551.8
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Day 50 (7 days after 3rd vaccination)
|
2.5 titer
Confidence interval could not be calculated as the variance was zero
|
88.1 titer
Interval 48.2 to 161.0
|
70.0 titer
Interval 41.5 to 117.9
|
138.4 titer
Interval 102.0 to 187.7
|
123.3 titer
Interval 100.0 to 152.0
|
187.5 titer
Interval 101.9 to 345.0
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 50Population: 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.
Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA.
Outcome measures
| Measure |
Group A1: CssBA 5 µg
n=5 Participants
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=4 Participants
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=9 Participants
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 Participants
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Day 1 (pre-vaccination)
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
2.8 titer
Interval 1.3 to 5.9
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Day 8 (7 days after 1st vaccination)
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
3.0 titer
Interval 1.1 to 8.1
|
11.7 titer
Interval 2.9 to 46.9
|
12.7 titer
Interval 3.8 to 42.8
|
9.0 titer
Interval 2.8 to 28.2
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Day 29 (7 days after 2nd vacination)
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
9.9 titer
Interval 0.5 to 198.1
|
4.1 titer
Interval 1.4 to 12.4
|
28.7 titer
Interval 8.8 to 93.9
|
19.3 titer
Interval 7.9 to 47.3
|
60.5 titer
Interval 44.9 to 81.6
|
|
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Day 50 (7 days after 3rd vaccination)
|
2.0 titer
Confidence interval could not be calculated as the variance was zero
|
13.3 titer
Interval 1.6 to 107.6
|
3.6 titer
Interval 1.4 to 9.5
|
24.7 titer
Interval 7.6 to 80.0
|
23.6 titer
Interval 8.5 to 65.4
|
18.7 titer
Interval 5.8 to 60.5
|
Adverse Events
Group A1: CssBA 5 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group A2: DmLT 100 ng
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B: CssBA 5 µg + DmLT 100 ng
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group C: CssBA 5 µg + DmLT 500 ng
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group D: CssBA 15 µg + DmLT 500 ng
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group E: CssBA 45 µg + DmLT 500 ng
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A1: CssBA 5 µg
n=5 participants at risk
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
|
Group A2: DmLT 100 ng
n=5 participants at risk
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
|
Group B: CssBA 5 µg + DmLT 100 ng
n=10 participants at risk
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
|
Group C: CssBA 5 µg + DmLT 500 ng
n=10 participants at risk
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group D: CssBA 15 µg + DmLT 500 ng
n=10 participants at risk
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
Group E: CssBA 45 µg + DmLT 500 ng
n=10 participants at risk
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
3/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Eye disorders
Conjunctivital hemorrhage
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Gastrointestinal disorders
Hemorroidal hemorrhage
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Axillary Pain
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Chills
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Fatigue
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Hangover
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Injection Site Pain
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Bruising
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vessel Puncture Site Hematoma
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
40.0%
2/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
60.0%
6/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Investigations
Neutrophil Count Decreased
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
40.0%
4/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Vascular disorders
Diastolic Hypertension
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Vascular disorders
Systolic Hypertension
|
40.0%
2/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Malaise
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Gastrointestinal disorders
Pyrexia
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Pain
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
50.0%
5/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
90.0%
9/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
90.0%
9/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Pruritus
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
70.0%
7/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Discoloration
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Erythema
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
80.0%
4/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
70.0%
7/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
70.0%
7/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
80.0%
8/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
80.0%
8/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Induration
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
60.0%
6/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
50.0%
5/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
60.0%
6/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Papule
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
General disorders
Vaccination Site Swelling
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
10.0%
1/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
40.0%
4/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
0.00%
0/5 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
60.0%
6/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
30.0%
3/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
20.0%
2/10 • From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place