Trial Outcomes & Findings for Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122 (NCT NCT04634513)
NCT ID: NCT04634513
Last Updated: 2026-02-02
Results Overview
Participants experiencing fever, diarrhea, or dysentery; solicited local adverse events; solicited systemic adverse events; and clinical safety laboratory adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
53 participants
Primary outcome timeframe
Solicited AEs: Cohorts 1-3 during 4 days of inpatient and memory aid for another 3 days; Cohort 4 memory aid over 7 days after each dose of study product Clinical Safety Labs: Cohorts 1-3: Day 1 and Day 8; Cohort 4: Days 1 and 29 and Days 8 and 36
Results posted on
2026-02-02
Participant Flow
In Cohorts 1-3, individuals received vaccine or placebo, according to random assignment and double-blinded conditions. In Cohort 4, individuals received either 2 doses of vaccine, 1 dose of vaccine, or only placebo; according to random assignment and double-blinded conditions. The reporting of outcomes discriminates those allocated to vaccine vs. placebo.
Participant milestones
| Measure |
Cohort 1: Shigella Vaccine at 10^8 Cfu
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 1: Placebo
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
5
|
2
|
6
|
2
|
12
|
12
|
6
|
|
Overall Study
COMPLETED
|
6
|
2
|
5
|
2
|
6
|
2
|
12
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122
Baseline characteristics by cohort
| Measure |
Cohort 1: Shigella Vaccine at 10^8 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 1: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
n=5 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
n=6 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
n=13 Participants
|
36.5 years
n=15 Participants
|
31.8 years
n=28 Participants
|
38 years
n=2 Participants
|
29.3 years
n=32 Participants
|
39 years
n=43 Participants
|
32.6 years
n=615 Participants
|
32.7 years
n=10 Participants
|
32.7 years
n=19 Participants
|
32.45 years
n=19 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=43 Participants
|
6 Participants
n=615 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=19 Participants
|
21 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
5 Participants
n=28 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
6 Participants
n=615 Participants
|
8 Participants
n=10 Participants
|
4 Participants
n=19 Participants
|
32 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=28 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=32 Participants
|
1 Participants
n=43 Participants
|
12 Participants
n=615 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=19 Participants
|
50 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
2 Participants
n=615 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
2 Participants
n=615 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=19 Participants
|
13 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
3 Participants
n=28 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=32 Participants
|
2 Participants
n=43 Participants
|
7 Participants
n=615 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=19 Participants
|
34 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=615 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Solicited AEs: Cohorts 1-3 during 4 days of inpatient and memory aid for another 3 days; Cohort 4 memory aid over 7 days after each dose of study product Clinical Safety Labs: Cohorts 1-3: Day 1 and Day 8; Cohort 4: Days 1 and 29 and Days 8 and 36Participants experiencing fever, diarrhea, or dysentery; solicited local adverse events; solicited systemic adverse events; and clinical safety laboratory adverse events
Outcome measures
| Measure |
Cohort 1: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
n=5 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
n=6 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
Cohort 1: Shigella Vaccine at 10^8 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants Experiencing Fever, Diarrhea, or Dysentery; Solicited Local Adverse Events; Solicited Systemic Adverse Events; and Clinical Safety Laboratory Adverse Events
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Only cohorts 1-3 are included in this outcome.
Vaccine organisms shed in stools in Cohorts 1-3
Outcome measures
| Measure |
Cohort 1: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
n=5 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
Cohort 1: Shigella Vaccine at 10^8 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
|---|---|---|---|---|---|---|---|---|---|
|
Vaccine Organisms Shed in Stools in Cohorts 1-3 - Cohorts 1-3
|
0 CFU/mL
Interval 0.0 to 0.0
|
1,130,000 CFU/mL
Interval 99000.0 to
|
0 CFU/mL
Interval 0.0 to 0.0
|
15,760,000 CFU/mL
|
0 CFU/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
694500 CFU/mL
Interval 239500.0 to 1500000.0
|
PRIMARY outcome
Timeframe: 2 daysPopulation: Only cohort 4 was analyzed in this outcome
Vaccine organisms shed in stools in Cohort 4
Outcome measures
| Measure |
Cohort 1: Placebo
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
n=6 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
Cohort 1: Shigella Vaccine at 10^8 Cfu
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
|---|---|---|---|---|---|---|---|---|---|
|
Vaccine Organisms Shed in Stools in Cohort 4
|
—
|
—
|
—
|
—
|
—
|
11805 CFU/mL
Interval 1733.0 to 313750.0
|
1510 CFU/mL
Interval 47.75 to 42050.0
|
0 CFU/mL
Interval 0.0 to 0.0
|
—
|
PRIMARY outcome
Timeframe: 7 daysFecal shed organisms found to be genetically stable, as defined as being PCR positive for Shigella (ipaH or virG), CFA/I (cfaB), and LTB (eltB)
Outcome measures
| Measure |
Cohort 1: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
n=5 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
n=6 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
Cohort 1: Shigella Vaccine at 10^8 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Genetically Stable Fecal Shed Organisms
|
0 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
10 Participants
|
9 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 28 daysSeroconversions (defined as 4-fold or higher compared to baseline) in antigen-specific ELISA antibody responses
Outcome measures
| Measure |
Cohort 1: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
n=5 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
n=12 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
n=6 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
Cohort 1: Shigella Vaccine at 10^8 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With ELISA Antibody Responses
LPS IgG
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Participants With ELISA Antibody Responses
IpaB IgG
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Participants With ELISA Antibody Responses
CFA/I IgG
|
0 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
8 Participants
|
7 Participants
|
0 Participants
|
6 Participants
|
|
Participants With ELISA Antibody Responses
LT IgG
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With ELISA Antibody Responses
LPS IgA
|
0 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Participants With ELISA Antibody Responses
IpaB IgA
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Participants With ELISA Antibody Responses
CFA/I IgA
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
|
Participants With ELISA Antibody Responses
LT IgA
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 daysResponses (defined as ≥8 spot forming cells/10\^6 PBMC) in antigen-specific ASC responses post-vaccination
Outcome measures
| Measure |
Cohort 1: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
n=5 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
n=2 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
n=11 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
n=11 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
n=6 Participants
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
Cohort 1: Shigella Vaccine at 10^8 Cfu
n=6 Participants
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With ASC Responses
IpaB IgA
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Participants With ASC Responses
LT IgA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With ASC Responses
CFA/I IgA
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Participants With ASC Responses
LT IgG
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With ASC Responses
LPS IgA
|
0 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
9 Participants
|
7 Participants
|
0 Participants
|
6 Participants
|
|
Participants With ASC Responses
LPS IgG
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Participants With ASC Responses
IpaB IgG
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Cohort 1: Shigella Vaccine at 10^8 Cfu
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Shigella Vaccine at 10^9 Cfu
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: Shigella Vaccine at 10^10 Cfu
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: Shigella 2-Dose Vaccine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: Shigella 1-Dose Vaccine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Shigella Vaccine at 10^8 Cfu
n=6 participants at risk
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 1: Placebo
n=2 participants at risk
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 2: Shigella Vaccine at 10^9 Cfu
n=5 participants at risk
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 2: Placebo
n=2 participants at risk
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 3: Shigella Vaccine at 10^10 Cfu
n=6 participants at risk
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 3: Placebo
n=2 participants at risk
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Placebo: Sodium bicarbonate buffer
|
Cohort 4: Shigella 2-Dose Vaccine
n=12 participants at risk
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Shigella 1-Dose Vaccine
n=12 participants at risk
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
strain CVD 1208S-122: Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
|
Cohort 4: Placebo
n=6 participants at risk
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Placebo: Sodium bicarbonate buffer
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Platelet Count Increased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
50.0%
1/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
20.0%
1/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
20.0%
1/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Nervous system disorders
Narcolepsy
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
8.3%
1/12 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
50.0%
1/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
40.0%
2/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Tooth Pain
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
General disorders
Malaise
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Infections and infestations
Streptococcal Sore Throat
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Infections and infestations
Viral Syndrome
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Injury, poisoning and procedural complications
Dog Bite
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Injury, poisoning and procedural complications
Wrist Pain
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Absolute Neutrophil Count Decreased
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
50.0%
1/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
16.7%
1/6 • 6 months
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
40.0%
2/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
16.7%
1/6 • 6 months
|
|
Investigations
Bilirubin Total Increased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Blood Pressure Diastolic Decreased
|
33.3%
2/6 • 6 months
|
0.00%
0/2 • 6 months
|
20.0%
1/5 • 6 months
|
0.00%
0/2 • 6 months
|
66.7%
4/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Blood Pressure Diastolic Increased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
60.0%
3/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Blood Pressure Systolic Decreased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
40.0%
2/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Body Temperature Increased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Heart Rate Decreased
|
33.3%
2/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
50.0%
1/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Heart Rate Increased
|
16.7%
1/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Hemoglobin Decreased
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/2 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/12 • 6 months
|
16.7%
1/6 • 6 months
|
Additional Information
Wilbur H. Chen, MD, MS, FACP, FIDSA
University of Maryland, School of Medicine
Phone: 410-706-5328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place