Trial Outcomes & Findings for Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea (NCT NCT01644565)
NCT ID: NCT01644565
Last Updated: 2021-02-12
Results Overview
Occurrence of related and unrelated to vaccine AE's
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
1 year
Results posted on
2021-02-12
Participant Flow
57 subjects were enrolled. An additional 2 subjects per cohort for Cohorts A-C and 2 subjects per group in Cohort D were included as alternates.
Participant milestones
| Measure |
Group A-1
Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
|
Group A-2
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
|
Group A-3
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-1
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-2
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-1
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-2
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-1
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-2
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
7
|
7
|
10
|
8
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
4
|
4
|
7
|
7
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group A-1
Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
|
Group A-2
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
|
Group A-3
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-1
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-2
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-1
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-2
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-1
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-2
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Undisclosed Medical History
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Family emergency
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Relocation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
Baseline characteristics by cohort
| Measure |
All Study Cohorts
n=57 Participants
Baseline data within Final Clinical Study Report was not broken out by groups or cohorts. No randomization was presented to detail which subject was in which group or cohort. Data is presented as it was detailed in the FCSR.
|
|---|---|
|
Age, Customized
Age 18 - 45 years
|
57 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOccurrence of related and unrelated to vaccine AE's
Outcome measures
| Measure |
Group A-1
n=4 Participants
Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
|
Group A-2
n=5 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
|
Group A-3
n=5 Participants
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-1
n=4 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-2
n=4 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-1
n=7 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-2
n=7 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-1
n=8 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-2
n=7 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
|---|---|---|---|---|---|---|---|---|---|
|
Safety - Occurrence of Adverse Events
Unrelated to Vaccine
|
17 Number of Adverse Events
|
14 Number of Adverse Events
|
16 Number of Adverse Events
|
14 Number of Adverse Events
|
10 Number of Adverse Events
|
20 Number of Adverse Events
|
8 Number of Adverse Events
|
20 Number of Adverse Events
|
26 Number of Adverse Events
|
|
Safety - Occurrence of Adverse Events
Related to Vaccine
|
7 Number of Adverse Events
|
21 Number of Adverse Events
|
19 Number of Adverse Events
|
20 Number of Adverse Events
|
18 Number of Adverse Events
|
23 Number of Adverse Events
|
25 Number of Adverse Events
|
38 Number of Adverse Events
|
25 Number of Adverse Events
|
SECONDARY outcome
Timeframe: baseline and post dosePopulation: A total of 55 subjects across cohorts received the minimum required 2 doses of investigation product(s) and were evaluable for the immunology analysis per protocol.
Number of participants with immune responses to vaccine antigens from baseline. Peripheral blood mononuclear cells (PBMCs) were collected to determine IgA antibody secreting cells (ASC) responses to dscCfaE and LTB. For each antigen, pre-and post-dosing samples were tested for total and vaccine-specific numbers of IgA-ASCs using the ELISPOT assay. A positive IgA-ASC response was defined as a \> 2-fold increase over the baseline value of the ASC per 10\^6 PBMC, when the number of ASC was \>0.5 per 10\^6 in the baseline sample. When the number of baseline ASCs was less than 0.5 per 10 PBMC, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10\^6 PBMC.
Outcome measures
| Measure |
Group A-1
n=5 Participants
Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
|
Group A-2
n=5 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
|
Group A-3
n=5 Participants
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-1
n=5 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-2
n=4 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-1
n=7 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-2
n=7 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-1
n=10 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-2
n=7 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Immune Responses to Vaccine Antigens
Serum IgG (aCfaE) - >4-fold rise in baseline titer
|
0 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants With Immune Responses to Vaccine Antigens
Serum IgG (aLT) - >4-fold rise in baseline titer
|
0 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Immune Responses to Vaccine Antigens
Serum IgA (aCfaE) - >4-fold rise in baseline titer
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Immune Responses to Vaccine Antigens
Serum IgA (aLT) - >4-fold risein baseline titer
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Immune Responses to Vaccine Antigens
IgA ASC (aCfaE) - >2-fold increase over baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Immune Responses to Vaccine Antigens
IgA ASC (aLT) - >2-fold increase over baseline
|
2 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 0, 21,42, 56, 70Population: Only subjects receiving at least 2 vaccine doses were included in this assessment. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation on not presenting standard deviation information is present in the FCSR.
Antigen-Specific IgA Geometric Mean Titers as defined by Fecal IgA. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation as to why standard deviation information is not present in the FCSR.
Outcome measures
| Measure |
Group A-1
n=5 Participants
Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
|
Group A-2
n=5 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
|
Group A-3
n=5 Participants
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-1
n=5 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-2
n=4 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-1
n=7 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-2
n=7 Participants
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-1
n=10 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-2
n=7 Participants
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
|---|---|---|---|---|---|---|---|---|---|
|
Antigen-Specific IgA Geometric Mean Titers
Day 0 - Anti-CfaE
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
9.56 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
43.66 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
11.34 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 21 - Anti-CfaE
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
8.77 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
5.94 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
9.63 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
59.75 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
16.95 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 42 - Anti-CfaE
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
12.06 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
22.99 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
162.67 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 56 - Anti-CfaE
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
44.22 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
4.29 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
52.52 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
23.47 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 70 - Anti-CfaE
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
9.47 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
8.63 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
18.12 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
8.98 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
190.44 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 0 - Anti-LT
|
22.70 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
43.05 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
16.62 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
28.66 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
19.78 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
114.77 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
59.38 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 21 - Anti-LT
|
15.00 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
189.39 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
13.89 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
46.07 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
19.82 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
9.85 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
16.56 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
137.37 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
51.60 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 42 - Anti-LT
|
12.37 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
74.60 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
15.87 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
28.66 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
44.93 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
13.40 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
19.48 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
126.85 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
321.36 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 56 - Anti-LT
|
33.30 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
83.68 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
18.16 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
31.53 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
40.24 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
23.00 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
23.35 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
142.69 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
27.83 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
|
Antigen-Specific IgA Geometric Mean Titers
Day 70 - Anti-LT
|
13.15 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
98.89 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
9.54 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
7.59 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
31.27 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
17.38 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
82.77 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
266.20 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
95.03 Geometric Mean Titers
Standard Deviation NA
The Final Clinical Study Report is the only record of available data, and no standard deviation data were included. Standard deviation data has not been located despite every effort made.
|
Adverse Events
Group A-1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group A-2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group A-3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B-1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B-2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group C-1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group C-2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group D-1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group D-2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A-1
n=5 participants at risk
Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
|
Group A-2
n=5 participants at risk
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
|
Group A-3
n=5 participants at risk
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-1
n=5 participants at risk
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group B-2
n=5 participants at risk
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-1
n=7 participants at risk
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group C-2
n=7 participants at risk
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-1
n=10 participants at risk
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
Group D-2
n=8 participants at risk
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE
Modified E. coli heat labile enterotoxin LTR192G
|
|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
GI symptoms
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
57.1%
4/7 • Number of events 4 • 1 year
|
42.9%
3/7 • Number of events 3 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Investigations
Hemoglobin decrease
|
0.00%
0/5 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
80.0%
4/5 • Number of events 4 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
57.1%
4/7 • Number of events 4 • 1 year
|
42.9%
3/7 • Number of events 3 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
Gastrointestinal disorders
Loose stools
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
Malaise
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
0.00%
0/5 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
Right axillary pain
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Psychiatric disorders
Sleepiness
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Tegaderm reaction
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Vaccine site pain
|
0.00%
0/5 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
57.1%
4/7 • Number of events 4 • 1 year
|
71.4%
5/7 • Number of events 5 • 1 year
|
50.0%
5/10 • Number of events 5 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vaccine site pruritus
|
0.00%
0/5 • 1 year
|
80.0%
4/5 • Number of events 4 • 1 year
|
80.0%
4/5 • Number of events 4 • 1 year
|
80.0%
4/5 • Number of events 4 • 1 year
|
100.0%
5/5 • Number of events 5 • 1 year
|
71.4%
5/7 • Number of events 5 • 1 year
|
85.7%
6/7 • Number of events 6 • 1 year
|
80.0%
8/10 • Number of events 8 • 1 year
|
100.0%
8/8 • Number of events 8 • 1 year
|
|
Injury, poisoning and procedural complications
Vaccine site reaction
|
20.0%
1/5 • Number of events 1 • 1 year
|
100.0%
5/5 • Number of events 5 • 1 year
|
100.0%
5/5 • Number of events 5 • 1 year
|
100.0%
5/5 • Number of events 5 • 1 year
|
100.0%
5/5 • Number of events 5 • 1 year
|
100.0%
7/7 • Number of events 7 • 1 year
|
100.0%
7/7 • Number of events 7 • 1 year
|
100.0%
10/10 • Number of events 10 • 1 year
|
100.0%
8/8 • Number of events 8 • 1 year
|
|
Injury, poisoning and procedural complications
Vaccine site swelling
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vaccine site tenderness
|
20.0%
1/5 • Number of events 1 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
85.7%
6/7 • Number of events 6 • 1 year
|
85.7%
6/7 • Number of events 6 • 1 year
|
80.0%
8/10 • Number of events 8 • 1 year
|
37.5%
3/8 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Vaccine site warmth
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Immune system disorders
Allergic rhinitis
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Investigations
ALT elevation
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle trauma, left
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Investigations
AST elevation
|
40.0%
2/5 • Number of events 2 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Bilateral bicep strain
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Investigations
BP elevation
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
Investigations
Creatinine elevation
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Dorsal foot pain
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Generalized eruption, truncal proximal UE
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Vascular disorders
Hemorrhoids
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
28.6%
2/7 • Number of events 2 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Calf soreness, left
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Facial trauma, left eye
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Left metatarsal stress fracture
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Left upper groin wound
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Menstrual cramps
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
Psychiatric disorders
Mental disorder NOS
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Investigations
Platelet decrease
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ankel sprain, right
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Knee hyperflexion, right
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
RUE Ecchymosis
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Infections and infestations
Scalp folliculitis
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Immune system disorders
Allergies, seasonal
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Sore throat
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Vascular disorders
Subsurface blood clot, left calf
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Immune system disorders
Tegaderm reaction
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
100.0%
8/8 • Number of events 8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
60.0%
3/5 • Number of events 3 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
28.6%
2/7 • Number of events 2 • 1 year
|
0.00%
0/7 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Nervous system disorders
Vasovagal episode
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
|
Infections and infestations
Viral syndrome
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/8 • 1 year
|
Additional Information
Ramiro L. Gutierrez, MD, MPH
Enteric Diseases Department, Naval Medical Research Center
Phone: 301-319-3193
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place