Trial Outcomes & Findings for Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge (NCT NCT03040687)
NCT ID: NCT03040687
Last Updated: 2019-06-14
Results Overview
Number of Participants with adverse events in groups receiving B7A- and CS6- hyperimmune (BSIgG) compared with the group receiving the nonhyperimmune product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
28 days
Results posted on
2019-06-14
Participant Flow
Sixty healthy adult naive subjects enrolled and received one of the three BSIgG products. Fifty-nine of those subjects were challenged with ETEC strain B7A.
Study specific screening occurred prior to enrollment. Eighty-two subjects signed study specific consent forms. Nineteen subjects screened failed. Three subjects were randomized but did not receive BSIgG.
Participant milestones
| Measure |
Anti-CS6 Group
Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti CS6 BSIgG product (Lot PD1601105CS)
B7A- CS6-expressing ETEC challenge strain
|
Anti-whole Cell B7A
Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti B7A BSIgG product (Lot PD1601132ET)
B7A- CS6-expressing ETEC challenge strain
|
Control Immunoglobulin Group
Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)
Bovine Immunoglobin Negative Control (Lot PD161071NC)
B7A- CS6-expressing ETEC challenge strain
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Anti-CS6 Group
Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti CS6 BSIgG product (Lot PD1601105CS)
B7A- CS6-expressing ETEC challenge strain
|
Anti-whole Cell B7A
Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti B7A BSIgG product (Lot PD1601132ET)
B7A- CS6-expressing ETEC challenge strain
|
Control Immunoglobulin Group
Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)
Bovine Immunoglobin Negative Control (Lot PD161071NC)
B7A- CS6-expressing ETEC challenge strain
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Baseline characteristics by cohort
| Measure |
Anti-CS6 Group
n=20 Participants
Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti CS6 BSIgG product (Lot PD1601105CS)
B7A- CS6-expressing ETEC challenge strain
|
Anti-whole Cell B7A
n=20 Participants
Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti B7A BSIgG product (Lot PD1601132ET)
B7A- CS6-expressing ETEC challenge strain
|
Control Immunoglobulin Group
n=20 Participants
Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)
Bovine Immunoglobin Negative Control (Lot PD161071NC)
B7A- CS6-expressing ETEC challenge strain
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
n=5 Participants
|
35.0 years
n=7 Participants
|
35.5 years
n=5 Participants
|
34 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysNumber of Participants with adverse events in groups receiving B7A- and CS6- hyperimmune (BSIgG) compared with the group receiving the nonhyperimmune product.
Outcome measures
| Measure |
Anti-CS6 Group
n=20 Participants
Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti CS6 BSIgG product (Lot PD1601105CS)
B7A- CS6-expressing ETEC challenge strain
|
Anti-whole Cell B7A
n=20 Participants
Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti B7A BSIgG product (Lot PD1601132ET)
B7A- CS6-expressing ETEC challenge strain
|
Control Immunoglobulin Group
n=20 Participants
Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)
Bovine Immunoglobin Negative Control (Lot PD161071NC)
B7A- CS6-expressing ETEC challenge strain
|
|---|---|---|---|
|
Safety of Serum Derived Bovine Immunoglobulins (BSIgG)
Abdominal Distension
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety of Serum Derived Bovine Immunoglobulins (BSIgG)
Abdominal Pain
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Safety of Serum Derived Bovine Immunoglobulins (BSIgG)
Defecation Urgency
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety of Serum Derived Bovine Immunoglobulins (BSIgG)
Flatulence
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Safety of Serum Derived Bovine Immunoglobulins (BSIgG)
Headache
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety of Serum Derived Bovine Immunoglobulins (BSIgG)
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety of Serum Derived Bovine Immunoglobulins (BSIgG)
None
|
14 Participants
|
11 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 28 daysComparison of the number and percentage of volunteers in the arms receiving the B7A- and CS6 BSIgG vs the arm receiving the nonhyperimmune BSIgG who develop moderate to severe diarrhea.
Outcome measures
| Measure |
Anti-CS6 Group
n=19 Participants
Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti CS6 BSIgG product (Lot PD1601105CS)
B7A- CS6-expressing ETEC challenge strain
|
Anti-whole Cell B7A
n=20 Participants
Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti B7A BSIgG product (Lot PD1601132ET)
B7A- CS6-expressing ETEC challenge strain
|
Control Immunoglobulin Group
n=20 Participants
Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)
Bovine Immunoglobin Negative Control (Lot PD161071NC)
B7A- CS6-expressing ETEC challenge strain
|
|---|---|---|---|
|
Efficacy of B7A and CS6- Hyperimmune Bovine Serum Immunoglobin to Protect Against Moderate to Severe Diarrhea After Challenge With the CS6 Expressing ETEC Strain B7A
|
12 Participants
|
7 Participants
|
14 Participants
|
Adverse Events
Anti-CS6 Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Anti-whole Cell B7A
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Control Immunoglobulin Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anti-CS6 Group
n=20 participants at risk
Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti CS6 BSIgG product (Lot PD1601105CS)
B7A- CS6-expressing ETEC challenge strain
|
Anti-whole Cell B7A
n=20 participants at risk
Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)
Anti B7A BSIgG product (Lot PD1601132ET)
B7A- CS6-expressing ETEC challenge strain
|
Control Immunoglobulin Group
n=20 participants at risk
Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)
Bovine Immunoglobin Negative Control (Lot PD161071NC)
B7A- CS6-expressing ETEC challenge strain
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distention
|
10.0%
2/20 • Number of events 2 • 6 months
|
10.0%
2/20 • Number of events 2 • 6 months
|
45.0%
9/20 • Number of events 9 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
60.0%
12/20 • Number of events 12 • 6 months
|
35.0%
7/20 • Number of events 7 • 6 months
|
60.0%
12/20 • Number of events 12 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain lower
|
0.00%
0/20 • 6 months
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal tenderness
|
25.0%
5/20 • Number of events 5 • 6 months
|
0.00%
0/20 • 6 months
|
35.0%
7/20 • Number of events 7 • 6 months
|
|
Immune system disorders
Apthous ulcer
|
0.00%
0/20 • 6 months
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthraligia
|
10.0%
2/20 • Number of events 2 • 6 months
|
0.00%
0/20 • 6 months
|
25.0%
5/20 • Number of events 5 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • 6 months
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
0.00%
0/20 • 6 months
|
|
Immune system disorders
Chills
|
35.0%
7/20 • Number of events 7 • 6 months
|
0.00%
0/20 • 6 months
|
25.0%
5/20 • Number of events 10 • 6 months
|
|
Gastrointestinal disorders
Decreased appetite
|
50.0%
10/20 • Number of events 10 • 6 months
|
20.0%
4/20 • Number of events 4 • 6 months
|
50.0%
10/20 • Number of events 10 • 6 months
|
|
Gastrointestinal disorders
Defecation Urgency
|
45.0%
9/20 • Number of events 9 • 6 months
|
20.0%
4/20 • Number of events 4 • 6 months
|
45.0%
9/20 • Number of events 9 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place