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Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A

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ClinicalTrials.gov Identifier: NCT02773446
Recruitment Status : Completed
First Posted : May 16, 2016
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
United States Department of Defense
PATH
Naval Medical Research Center
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Healthy Volunteer
Intervention Biological: ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer
Enrollment 47
Recruitment Details  
Pre-assignment Details Cohort 2 group A consists of 11 subjects from Cohort 1. These subjects were re admitted for a second admission. The total number of subjects enrolled was 47.
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Hide Arm/Group Description

Volunteers will receive 8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Volunteers will receive 9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Volunteers will receive 9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Volunteers will receive 10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint will receive optimal regimen as determined by analysis after Cohort 1.

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Naive subjects who will receive optimal regimen as determined by analysis after Cohort 1

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Period Title: First Admission
Started 7 7 7 7 0 0
Completed 6 7 7 6 0 0
Not Completed 1 0 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             0
Lost to Follow-up             1             0             0             0             0             0
Period Title: Second Admission
Started 0 0 0 0 11 19
Completed 0 0 0 0 11 19
Not Completed 0 0 0 0 0 0
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B Total
Hide Arm/Group Description

8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint - 9 logs of E.coli strain B7A

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Naive subjects - 9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Total of all reporting groups
Overall Number of Baseline Participants 7 7 7 7 11 19 58
Hide Baseline Analysis Population Description
Cohort 2 group A consists of 11 subjects from Cohort 1. These subjects were re admitted for a second admission. The total number of subjects enrolled was 47.
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Cohort 1 Number Analyzed 7 participants 7 participants 7 participants 7 participants 0 participants 0 participants 28 participants
36
(29.5 to 39)
34
(31.5 to 37)
39
(31 to 40.5)
35
(33 to 40.5)
34.5
(32 to 40)
Cohort 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 11 participants 19 participants 30 participants
39
(32 to 41)
35
(30 to 42)
36
(30 to 41.5)
[1]
Measure Analysis Population Description: Cohort 2 group A consists of 11 subjects from Cohort 1. These subjects were re admitted for a second admission. The total number of subjects enrolled was 47. Each cohort was analyzed separately.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Cohort 1 Number Analyzed 7 participants 7 participants 7 participants 7 participants 0 participants 0 participants 28 participants
Female
2
  28.6%
3
  42.9%
2
  28.6%
1
  14.3%
0 0
8
  28.6%
Male
5
  71.4%
4
  57.1%
5
  71.4%
6
  85.7%
0 0
20
  71.4%
Cohort 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 11 participants 19 participants 30 participants
Female 0 0 0 0
3
  27.3%
5
  26.3%
8
  26.7%
Male 0 0 0 0
8
  72.7%
14
  73.7%
22
  73.3%
[1]
Measure Analysis Population Description: Cohort 2 group A consists of 11 subjects from Cohort 1. These subjects were re admitted for a second admission. The total number of subjects enrolled was 47. Each cohort was analyzed separately.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Cohort 1 Number Analyzed 7 participants 7 participants 7 participants 7 participants 0 participants 0 participants 28 participants
Hispanic or Latino
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0 0
1
   3.6%
Not Hispanic or Latino
7
 100.0%
6
  85.7%
7
 100.0%
7
 100.0%
0 0
27
  96.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
0
   0.0%
Cohort 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 11 participants 19 participants 30 participants
Hispanic or Latino 0 0 0 0
0
   0.0%
5
  26.3%
5
  16.7%
Not Hispanic or Latino 0 0 0 0
11
 100.0%
14
  73.7%
25
  83.3%
Unknown or Not Reported 0 0 0 0
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Cohort 2 group A consists of 11 subjects from Cohort 1. These subjects were re admitted for a second admission. The total number of subjects enrolled was 47. Each cohort was analyzed separately.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Cohort 1 Number Analyzed 7 participants 7 participants 7 participants 7 participants 0 participants 0 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
0
   0.0%
Asian
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
0
   0.0%
Black or African American
5
  71.4%
6
  85.7%
7
 100.0%
6
  85.7%
0 0
24
  85.7%
White
1
  14.3%
1
  14.3%
0
   0.0%
1
  14.3%
0 0
3
  10.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
0
   0.0%
Cohort 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 11 participants 19 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.3%
1
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
 100.0%
13
  68.4%
24
  80.0%
White
0
   0.0%
2
  10.5%
2
   6.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
  15.8%
3
  10.0%
[1]
Measure Analysis Population Description: Cohort 2 group A consists of 11 subjects from Cohort 1. These subjects were re admitted for a second admission. The total number of subjects enrolled was 47. Each cohort was analyzed separately.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 7 participants 7 participants 11 participants 19 participants 58 participants
Cohort 1
7
 100.0%
7
 100.0%
7
 100.0%
7
 100.0%
0
   0.0%
0
   0.0%
28
  48.3%
Cohort 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11
 100.0%
19
 100.0%
30
  51.7%
1.Primary Outcome
Title Number of Participants With Safety- Solicited Symptoms Related to Challenge Administration
Hide Description Solicited symptoms (vomiting, abdominal pain, bloating, lightheadedness, anorexia, generalized myalgia, arthralgias, abdominal cramping, constipation, nausea, malaise, headache, flatulence)
Time Frame 6 days post-challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Hide Arm/Group Description:

8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint 9 logs of E.coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Naive subjects - 9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Overall Number of Participants Analyzed 7 7 7 7 11 19
Measure Type: Count of Participants
Unit of Measure: Participants
Vomiting
0
   0.0%
0
   0.0%
3
  42.9%
2
  28.6%
1
   9.1%
3
  15.8%
Abdominal Pain
3
  42.9%
4
  57.1%
5
  71.4%
4
  57.1%
7
  63.6%
12
  63.2%
Bloating
5
  71.4%
6
  85.7%
5
  71.4%
4
  57.1%
5
  45.5%
11
  57.9%
Lightheadedness
1
  14.3%
4
  57.1%
4
  57.1%
1
  14.3%
2
  18.2%
3
  15.8%
Anorexia
4
  57.1%
4
  57.1%
5
  71.4%
4
  57.1%
4
  36.4%
14
  73.7%
Generalized Myalgia
0
   0.0%
1
  14.3%
0
   0.0%
1
  14.3%
2
  18.2%
3
  15.8%
Arthralgias
0
   0.0%
1
  14.3%
0
   0.0%
1
  14.3%
1
   9.1%
3
  15.8%
Abdominal Cramping
5
  71.4%
5
  71.4%
5
  71.4%
3
  42.9%
7
  63.6%
13
  68.4%
Constipation
1
  14.3%
1
  14.3%
2
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea
3
  42.9%
3
  42.9%
4
  57.1%
3
  42.9%
3
  27.3%
8
  42.1%
Malaise
4
  57.1%
4
  57.1%
4
  57.1%
3
  42.9%
4
  36.4%
10
  52.6%
Headache
3
  42.9%
4
  57.1%
4
  57.1%
5
  71.4%
4
  36.4%
10
  52.6%
Flatulence
7
 100.0%
6
  85.7%
6
  85.7%
4
  57.1%
7
  63.6%
10
  52.6%
2.Primary Outcome
Title Moderate-severe Diarrhea
Hide Description

Moderate-severe diarrhea post challenge defined as

  • moderate diarrhea: 4 to 5 loose/liquid stools or 401-800 of loose/liquid stool in any 24-hour period
  • Severe diarrhea greater than or equal to 6 loose/liquid stools or greater than 800 g of loose/liquid stools in any 24-hour period
Time Frame 5 days post challenge (Cohort 1 and Cohort 2 group B) 7 days post challenge (Cohort 2 Group A)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Hide Arm/Group Description:

8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint- 9 logs of E. coli strain B7A after overnight fast

Naive subjects -9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Overall Number of Participants Analyzed 7 7 7 7 11 19
Measure Type: Count of Participants
Unit of Measure: Participants
3
  42.9%
3
  42.9%
5
  71.4%
5
  71.4%
5
  45.5%
11
  57.9%
3.Primary Outcome
Title Moderate-severe Diarrhea in Subjects Receiving Homologous Rechallenge
Hide Description

Moderate-severe diarrhea post-challenge defined as

  • Moderate diarrhea: 4 to 5 loose/liquid stools or 401-800g of loose/liquid stool in any 24- hour period
  • Severe diarrhea: greater than or equal to 6 loose/liquid stools or greater than 800 g of loose/liquid stool in any 24-hour period
Time Frame 7 days post-challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 2 Group A
Hide Arm/Group Description:

subjects from Cohort 1 who met primary endpoint 9 logs of E.coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
5
  45.5%
4.Primary Outcome
Title Number of Participants With Safety -Solicited Symptoms Unrelated to Challenge Administration
Hide Description Safety solicited symptoms unrelated to challenge administration (vomiting, abdominal pain, bloating, lightheadedness, anorexia, generalized myalgia, arthralgias, abdominal cramping, constipation, nausea, malaise, headache, flatulence)
Time Frame 6 days post-challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Hide Arm/Group Description:

8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint 9 logs of E.coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Naive subjects - 9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Overall Number of Participants Analyzed 7 7 7 7 11 19
Measure Type: Count of Participants
Unit of Measure: Participants
Vomiting
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Abdominal pain
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bloating
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lightheadedness
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Anorexia
1
  14.3%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Generalized myalgia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Arthralgias
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
Abdominal Cramping
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Constipation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Malaise
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Headache
1
  14.3%
1
  14.3%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
Flatulence
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Immune Response to Challenge (Serology)
Hide Description [Not Specified]
Time Frame 28 days post challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Hide Arm/Group Description:

8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint 9 logs of E.coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Naive subjects - 9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Overall Number of Participants Analyzed 7 7 7 7 11 19
Measure Type: Count of Participants
Unit of Measure: Participants
IgG C66
1
  14.3%
3
  42.9%
0
   0.0%
0
   0.0%
3
  27.3%
4
  21.1%
IgG LT
2
  28.6%
1
  14.3%
3
  42.9%
4
  57.1%
6
  54.5%
10
  52.6%
IgG LPS
2
  28.6%
2
  28.6%
1
  14.3%
4
  57.1%
4
  36.4%
7
  36.8%
IgA CS6
1
  14.3%
1
  14.3%
2
  28.6%
0
   0.0%
1
   9.1%
2
  10.5%
IgA LT
1
  14.3%
0
   0.0%
2
  28.6%
1
  14.3%
4
  36.4%
3
  15.8%
IgA LPS
5
  71.4%
6
  85.7%
4
  57.1%
7
 100.0%
6
  54.5%
18
  94.7%
6.Secondary Outcome
Title Immune Response to Challenge
Hide Description Antibody in Lymphocyte Supernatant (ALS) Immunoglobin G (IgG) (CS6) coli surface antigen 6 Immunoglobin G (IgG) heat labile Toxin (LT) Immunoglobin G (IgG) (LPS) Lipopolysaccharide Immunoglobin A (IgA) (CS6) coli surface antigen 6 Immunoglobin A (IgA) heat labile Toxin (LT) Immunoglobin A (IgG) (LPS) Lipopolysaccharide
Time Frame 6 days post challenge
Hide Outcome Measure Data
Hide Analysis Population Description
samples for ALS IgG and IgA were unavailable for 1 participant in cohort 2 group A Samples for ALS IgG CS6, LT and IgA CS6 were unavailable for 1 participant in cohort 2 group B
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Hide Arm/Group Description:

8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint 9 logs of E.coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Naive subjects - 9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Overall Number of Participants Analyzed 7 7 7 7 11 19
Measure Type: Number
Unit of Measure: participants
IgG C66 Number Analyzed 7 participants 7 participants 7 participants 7 participants 10 participants 18 participants
2 2 0 1 5 6
IgG LT Number Analyzed 7 participants 7 participants 7 participants 7 participants 10 participants 18 participants
1 2 4 2 8 9
IgG LPS Number Analyzed 7 participants 7 participants 7 participants 7 participants 10 participants 19 participants
3 3 1 5 3 18
IgA CS6 Number Analyzed 7 participants 7 participants 7 participants 7 participants 10 participants 18 participants
3 4 0 2 6 6
IgA LT Number Analyzed 7 participants 7 participants 7 participants 7 participants 10 participants 19 participants
1 0 1 1 4 8
IgA LPS Number Analyzed 7 participants 7 participants 7 participants 7 participants 10 participants 19 participants
5 7 5 6 8 19
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Hide Arm/Group Description

8 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

9 logs of E. coli strain B7A after overnight fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

10 logs of E. coli strain B7A after 90 minute fast

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

subjects from Cohort 1 who met primary endpoint will receive optimal regimen as determined by analysis after Cohort 1.

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

Naive subjects who will receive optimal regimen as determined by analysis after Cohort 1

ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria

All-Cause Mortality
Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/11 (0.00%)      1/19 (5.26%)    
Respiratory, thoracic and mediastinal disorders             
Pulmonary Embolism  1  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  19
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Group A Cohort 1 Group B Cohort 1 Group C Cohort 1 Group D Cohort 2 Group A Cohort 2 Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      3/7 (42.86%)      7/7 (100.00%)      3/7 (42.86%)      4/11 (36.36%)      11/19 (57.89%)    
Cardiac disorders             
Hypertension * 1  1/7 (14.29%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0
Hypotension * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1
Hypovolemia * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0
Tachycardia * 1  1/7 (14.29%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1 0/11 (0.00%)  0 2/19 (10.53%)  19
Gastrointestinal disorders             
Abdominal Distention * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0
High pitched bowel sounds * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0
Hyperactive Bowel Sounds * 1  5/7 (71.43%)  5 2/7 (28.57%)  2 7/7 (100.00%)  7 3/7 (42.86%)  3 3/11 (27.27%)  3 8/19 (42.11%)  8
Rectal Pain * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0
Immune system disorders             
Fever * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 1/11 (9.09%)  1 3/19 (15.79%)  3
Respiratory, thoracic and mediastinal disorders             
Shortness of Breath * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kawsar Talaat
Organization: Johns Hopkins University
Phone: 410-502-9627
EMail: ktalaat@jhu.edu
Publications:
Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02773446    
Other Study ID Numbers: CIR303 B7A
First Submitted: May 10, 2016
First Posted: May 16, 2016
Results First Submitted: November 29, 2017
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018