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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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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.
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Age, Continuous
[1] Median (Inter-Quartile Range) Unit of measure: Years |
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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)
|
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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)
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[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.
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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.
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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.
|
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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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%
|
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[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.
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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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%
|
Name/Title: | Kawsar Talaat |
Organization: | Johns Hopkins University |
Phone: | 410-502-9627 |
EMail: | ktalaat@jhu.edu |
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 |