Trial Outcomes & Findings for Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults (NCT NCT01739231)
NCT ID: NCT01739231
Last Updated: 2019-02-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Results posted on
2019-02-12
Participant Flow
Participant milestones
| Measure |
ACE527 Alone
In Part A, subjects received three oral doses of ACE527 at 0, 1, and 2 months. For Part B of the study, eligible subjects who expressed interest of the study were administered H10407 challenge strain 5-7 months after the three-dose vaccination series.
|
ACE527 Plus dmLT
In Part A, subjects received three oral doses of ACE527 with mucosal adjuvant (dmLT) at 0, 1, and 2 months. For Part B of the study, eligible subjects who expressed interest of the study were administered H10407 challenge strain 5-7 months after the three-dose vaccination series.
|
Control: Part A and B
In Part A, subjects received three oral doses of CeraVacx placebo at 0, 1, and 2 months. For Part B of the study, eligible subjects who expressed interest of the study, plus participants who had not participated in Part A, were administered H10407 challenge strain 5-7 months after the three-dose vaccination series.
|
Control: Part B Only
Participants who were recruited after Part A of the study, for Part B. Participants were administered H10407 challenge strain concurrently with other subjects in Part B.
|
|---|---|---|---|---|
|
Part A
STARTED
|
24
|
24
|
12
|
0
|
|
Part A
Received All 3 Vaccinations
|
21
|
20
|
12
|
0
|
|
Part A
COMPLETED
|
20
|
17
|
12
|
0
|
|
Part A
NOT COMPLETED
|
4
|
7
|
0
|
0
|
|
Part B
STARTED
|
20
|
17
|
12
|
21
|
|
Part B
Challenged
|
13
|
13
|
10
|
21
|
|
Part B
COMPLETED
|
13
|
12
|
10
|
19
|
|
Part B
NOT COMPLETED
|
7
|
5
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
Baseline characteristics by cohort
| Measure |
Part A: ACE527 Alone
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
Part B: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months and participated in Part B of the study.
|
Part B: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months and participated in Part B of the study.
|
Part B: Control
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months and participated in Part B of the study, plus additional participants who did not participate in Part A.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Part B · Unknown or Not Reported
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Age, Continuous
Part A
|
35.8 years
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
37.6 years
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
37.0 years
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
36.8 years
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Age, Continuous
Part B
|
—
|
—
|
—
|
37.0 years
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
37.6 years
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
36.5 years
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
36.9 years
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Sex: Female, Male
Part A · Female
|
7 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
9 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
1 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
17 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Sex: Female, Male
Part A · Male
|
17 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
15 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
11 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
43 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Sex: Female, Male
Part B · Female
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
4 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
6 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
6 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
16 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Sex: Female, Male
Part B · Male
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
9 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
7 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
25 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
41 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Ethnicity (NIH/OMB)
Part A · Hispanic or Latino
|
2 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
1 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
1 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
4 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Ethnicity (NIH/OMB)
Part A · Not Hispanic or Latino
|
22 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
23 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
11 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
56 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Ethnicity (NIH/OMB)
Part A · Unknown or Not Reported
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Ethnicity (NIH/OMB)
Part B · Hispanic or Latino
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
1 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
1 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
1 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
3 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Ethnicity (NIH/OMB)
Part B · Not Hispanic or Latino
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
12 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
12 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
30 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
54 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part A · American Indian or Alaska Native
|
1 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
1 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part A · Asian
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
0 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part A · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
0 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part A · Black or African American
|
20 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
21 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
12 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
53 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part A · White
|
3 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
3 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
6 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part A · More than one race
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
0 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part A · Unknown or Not Reported
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
0 Participants
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part B · American Indian or Alaska Native
|
—
|
—
|
—
|
1 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
1 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part B · Asian
|
—
|
—
|
—
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part B · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part B · Black or African American
|
—
|
—
|
—
|
10 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
10 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
29 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
49 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part B · White
|
—
|
—
|
—
|
2 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
3 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
2 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
7 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part B · More than one race
|
—
|
—
|
—
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Race (NIH/OMB)
Part B · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
0 Participants
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Height
Part A
|
69.4 inches
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
67.4 inches
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
69.1 inches
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
68.5 inches
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Height
Part B
|
—
|
—
|
—
|
70.0 inches
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
66.7 inches
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
69 inches
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
68.7 inches
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Weight
Part A
|
190.3 pounds
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
171.7 pounds
n=24 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
176.2 pounds
n=12 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
—
|
—
|
—
|
180.0 pounds
n=60 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
|
Weight
Part B
|
—
|
—
|
—
|
197.8 pounds
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
176.5 pounds
n=13 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
184.5 pounds
n=31 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
185.7 pounds
n=57 Participants • 13 participants receiving ACE527 alone, 13 receiving ACE527 plus dmLT, and 12 receiving placebo participated in both Part A and Part B; and 21 participated in Part B only. Each part of the study was analyzed separately.
|
PRIMARY outcome
Timeframe: up to 1 month after last vaccination (3 months)Population: Participants in Part A of the study who received at least one dose of the study product.
Unsolicited adverse events were collected throughout Part A of the study, were graded for severity, and assessed for relationship to vaccine. Withdrawal from the study due to adverse event was determined at the discretion of the study staff.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal
Serious adverse event
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal
Adverse event leading to withdrawal
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: up to 1 month after last vaccination (3 months)Population: Participants in Part A of the study who received at least one dose of the study product.
Unsolicited adverse events were collected throughout Part A of the study, were graded for severity, and assessed for relationship to vaccine. Generally, mild severity is discomfort with no disruption of normal daily activities and relieved with or without symptomatic treatment; moderate severity is discomfort sufficient to reduce or affect normal daily activity somewhat and only partially relieved with symptomatic treatment; and severe is discomfort sufficient to reduce or affect normal daily activity considerably; prevents regular activities, and not relieved with symptomatic treatment. Additional description of severity for diarrhea, body temperature, and vomiting is described in the protocol.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
Not related: Mild
|
10 Participants
|
9 Participants
|
4 Participants
|
|
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
Not related: Moderate
|
8 Participants
|
2 Participants
|
3 Participants
|
|
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
Not related: Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
Related: Mild
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
Related: Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
Related: Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 1 week after each vaccination (at 0, 1, and 2 months)Population: Participants in Part A of the study who received at least one dose of the study product.
Solicited reactions were collected 1 week after each vaccination.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number of Solicited Reactions
Loose stools
|
5 Participants
|
11 Participants
|
2 Participants
|
|
Part A: Number of Solicited Reactions
Fever
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number of Solicited Reactions
Nausea
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Part A: Number of Solicited Reactions
Vomiting
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Solicited Reactions
Abdominal Pain
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Part A: Number of Solicited Reactions
Urgency of Defecation
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Part A: Number of Solicited Reactions
Borborygmus (gurgling)
|
6 Participants
|
6 Participants
|
2 Participants
|
|
Part A: Number of Solicited Reactions
Malaise
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Part A: Number of Solicited Reactions
Headache
|
5 Participants
|
7 Participants
|
1 Participants
|
|
Part A: Number of Solicited Reactions
Anorexia
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Part A: Number of Solicited Reactions
Chills
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Solicited Reactions
Diarrhea
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Solicited Reactions
Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Solicited Reactions
Any reaction
|
12 Participants
|
15 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Defined as a four-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
0 Participants
|
7 Participants
|
12 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 3
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
0 Participants
|
12 Participants
|
10 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
0 Participants
|
11 Participants
|
13 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 3
|
0.93 fold change
Interval 0.69 to 1.248
|
1.02 fold change
Interval 0.828 to 1.261
|
0.83 fold change
Interval 0.711 to 0.971
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
1.04 fold change
Interval 0.759 to 1.424
|
3.39 fold change
Interval 1.865 to 6.152
|
5.05 fold change
Interval 2.646 to 9.639
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
0.87 fold change
Interval 0.698 to 1.084
|
1.13 fold change
Interval 0.842 to 1.511
|
1.03 fold change
Interval 0.829 to 1.274
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 3
|
0.97 fold change
Interval 0.754 to 1.245
|
1.11 fold change
Interval 0.858 to 1.432
|
0.94 fold change
Interval 0.703 to 1.269
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
1.08 fold change
Interval 0.767 to 1.528
|
4.14 fold change
Interval 2.398 to 7.161
|
3.08 fold change
Interval 2.232 to 4.237
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
0.97 fold change
Interval 0.693 to 1.355
|
1.23 fold change
Interval 0.94 to 1.602
|
1.38 fold change
Interval 0.949 to 2.017
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
0.96 fold change
Interval 0.73 to 1.272
|
4.15 fold change
Interval 2.557 to 6.733
|
5.62 fold change
Interval 2.953 to 10.7
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
1.05 fold change
Interval 0.746 to 1.48
|
1.04 fold change
Interval 0.766 to 1.406
|
1.05 fold change
Interval 0.723 to 1.531
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
0.343 titer
Interval 0.229 to 0.513
|
0.413 titer
Interval 0.278 to 0.615
|
0.332 titer
Interval 0.24 to 0.46
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Pre-Vaccination 1
|
0.326 titer
Interval 0.231 to 0.46
|
0.387 titer
Interval 0.263 to 0.569
|
0.318 titer
Interval 0.226 to 0.448
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 3
|
0.303 titer
Interval 0.203 to 0.451
|
0.395 titer
Interval 0.272 to 0.574
|
0.264 titer
Interval 0.189 to 0.369
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
0.339 titer
Interval 0.228 to 0.504
|
1.310 titer
Interval 0.708 to 2.425
|
1.606 titer
Interval 0.837 to 3.081
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
0.284 titer
Interval 0.197 to 0.409
|
0.436 titer
Interval 0.298 to 0.639
|
0.334 titer
Interval 0.242 to 0.462
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 3
|
0.316 titer
Interval 0.208 to 0.48
|
0.457 titer
Interval 0.323 to 0.647
|
0.306 titer
Interval 0.228 to 0.411
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
0.353 titer
Interval 0.233 to 0.535
|
1.603 titer
Interval 0.951 to 2.7
|
0.998 titer
Interval 0.675 to 1.475
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
0.316 titer
Interval 0.248 to 0.402
|
0.465 titer
Interval 0.333 to 0.649
|
0.437 titer
Interval 0.297 to 0.642
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
0.314 titer
Interval 0.214 to 0.461
|
1.573 titer
Interval 0.976 to 2.533
|
1.775 titer
Interval 1.038 to 3.036
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Defined as a four-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
0 Participants
|
18 Participants
|
12 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 3
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
0 Participants
|
7 Participants
|
3 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 3
|
0.90 fold change
Interval 0.807 to 0.995
|
0.95 fold change
Interval 0.88 to 1.032
|
0.89 fold change
Interval 0.785 to 1.013
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
0.96 fold change
Interval 0.854 to 1.08
|
10.95 fold change
Interval 6.655 to 18.0
|
6.45 fold change
Interval 3.598 to 11.6
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
0.92 fold change
Interval 0.802 to 1.062
|
1.47 fold change
Interval 1.121 to 1.927
|
1.06 fold change
Interval 0.843 to 1.342
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 3
|
1.00 fold change
Interval 0.857 to 1.164
|
1.65 fold change
Interval 1.105 to 2.475
|
1.07 fold change
Interval 0.856 to 1.337
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
0.92 fold change
Interval 0.828 to 1.025
|
1.99 fold change
Interval 1.388 to 2.847
|
1.58 fold change
Interval 1.22 to 2.048
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
0.93 fold change
Interval 0.753 to 1.142
|
1.20 fold change
Interval 0.927 to 1.544
|
1.01 fold change
Interval 0.789 to 1.283
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
0.89 fold change
Interval 0.74 to 1.071
|
2.65 fold change
Interval 1.82 to 3.855
|
1.62 fold change
Interval 1.142 to 2.303
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
0.89 fold change
Interval 0.74 to 1.071
|
0.96 fold change
Interval 0.818 to 1.118
|
0.84 fold change
Interval 0.692 to 1.023
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Pre-Vaccination 1
|
0.175 titer
Interval 0.139 to 0.221
|
0.183 titer
Interval 0.152 to 0.221
|
0.178 titer
Interval 0.144 to 0.219
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 3
|
0.157 titer
Interval 0.128 to 0.192
|
0.175 titer
Interval 0.145 to 0.21
|
0.158 titer
Interval 0.132 to 0.191
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
0.168 titer
Interval 0.131 to 0.216
|
2.008 titer
Interval 1.235 to 3.266
|
1.146 titer
Interval 0.705 to 1.865
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
0.162 titer
Interval 0.133 to 0.197
|
0.269 titer
Interval 0.205 to 0.354
|
0.186 titer
Interval 0.146 to 0.236
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 3
|
0.175 titer
Interval 0.136 to 0.225
|
0.307 titer
Interval 0.207 to 0.455
|
0.179 titer
Interval 0.143 to 0.223
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
0.161 titer
Interval 0.131 to 0.198
|
0.365 titer
Interval 0.25 to 0.532
|
0.274 titer
Interval 0.209 to 0.358
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
0.171 titer
Interval 0.125 to 0.233
|
0.208 titer
Interval 0.167 to 0.258
|
0.186 titer
Interval 0.146 to 0.236
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
0.164 titer
Interval 0.121 to 0.222
|
0.460 titer
Interval 0.32 to 0.663
|
0.299 titer
Interval 0.215 to 0.416
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
0.164 titer
Interval 0.121 to 0.222
|
0.173 titer
Interval 0.142 to 0.21
|
0.155 titer
Interval 0.12 to 0.201
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Defined as a four-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 3
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
0 Participants
|
7 Participants
|
2 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 3
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
0 Participants
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 3
|
0.87 fold change
Interval 0.675 to 1.133
|
1.17 fold change
Interval 0.934 to 1.477
|
0.96 fold change
Interval 0.707 to 1.306
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
1.13 fold change
Interval 0.961 to 1.337
|
2.95 fold change
Interval 2.093 to 4.153
|
1.67 fold change
Interval 1.129 to 2.473
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
0.89 fold change
Interval 0.652 to 1.229
|
1.87 fold change
Interval 1.493 to 2.333
|
1.21 fold change
Interval 0.89 to 1.643
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 3
|
1.16 fold change
Interval 0.864 to 1.547
|
1.66 fold change
Interval 1.304 to 2.118
|
1.38 fold change
Interval 0.948 to 2.019
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
0.97 fold change
Interval 0.769 to 1.214
|
2.08 fold change
Interval 1.379 to 3.141
|
1.50 fold change
Interval 1.102 to 2.051
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
1.22 fold change
Interval 0.808 to 1.85
|
1.74 fold change
Interval 1.343 to 2.256
|
1.40 fold change
Interval 0.996 to 1.977
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
1.00 fold change
Interval 0.679 to 1.469
|
2.68 fold change
Interval 1.857 to 3.872
|
1.68 fold change
Interval 1.174 to 2.402
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
1.14 fold change
Interval 0.813 to 1.599
|
1.14 fold change
Interval 0.864 to 1.497
|
0.94 fold change
Interval 0.678 to 1.302
|
PRIMARY outcome
Timeframe: Pre all vaccinations; day 3 post-vaccination 1 and 2; day 7 post all vaccinations; 4 weeks post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Pre-Vaccination 1
|
0.292 titer
Interval 0.194 to 0.441
|
0.306 titer
Interval 0.238 to 0.395
|
0.322 titer
Interval 0.235 to 0.441
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 3
|
0.256 titer
Interval 0.172 to 0.38
|
0.360 titer
Interval 0.25 to 0.518
|
0.310 titer
Interval 0.232 to 0.414
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
0.331 titer
Interval 0.222 to 0.495
|
0.904 titer
Interval 0.673 to 1.214
|
0.539 titer
Interval 0.387 to 0.749
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
0.262 titer
Interval 0.191 to 0.359
|
0.572 titer
Interval 0.414 to 0.79
|
0.389 titer
Interval 0.314 to 0.48
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 3
|
0.338 titer
Interval 0.211 to 0.541
|
0.531 titer
Interval 0.382 to 0.74
|
0.418 titer
Interval 0.306 to 0.57
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
0.283 titer
Interval 0.21 to 0.381
|
0.638 titer
Interval 0.403 to 1.009
|
0.466 titer
Interval 0.358 to 0.607
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
0.357 titer
Interval 0.236 to 0.542
|
0.509 titer
Interval 0.384 to 0.674
|
0.431 titer
Interval 0.318 to 0.584
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
0.292 titer
Interval 0.189 to 0.45
|
0.784 titer
Interval 0.528 to 1.164
|
0.515 titer
Interval 0.372 to 0.714
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
0.333 titer
Interval 0.206 to 0.54
|
0.358 titer
Interval 0.266 to 0.481
|
0.288 titer
Interval 0.223 to 0.374
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Defined as a four-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 3
|
1 fold change
Interval 1.0 to 1.0
|
0.95 fold change
Interval 0.889 to 1.01
|
1.00 fold change
Interval 0.987 to 1.008
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
1 fold change
Interval 1.0 to 1.0
|
0.96 fold change
Interval 0.9 to 1.015
|
1.00 fold change
Interval 0.987 to 1.008
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
1 fold change
Interval 1.0 to 1.0
|
0.96 fold change
Interval 0.9 to 1.015
|
1.00 fold change
Interval 0.987 to 1.008
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 3
|
1 fold change
Interval 1.0 to 1.0
|
0.97 fold change
Interval 0.902 to 1.045
|
1.03 fold change
Interval 0.985 to 1.086
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
1 fold change
Interval 1.0 to 1.0
|
0.96 fold change
Interval 0.898 to 1.03
|
1.00 fold change
Interval 0.99 to 1.003
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
1 fold change
Interval 1.0 to 1.0
|
0.97 fold change
Interval 0.871 to 1.084
|
1.04 fold change
Interval 0.979 to 1.11
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
1 fold change
Interval 1.0 to 1.0
|
0.96 fold change
Interval 0.882 to 1.037
|
1.03 fold change
Interval 0.986 to 1.078
|
|
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
1.01 fold change
Interval 0.993 to 1.019
|
0.96 fold change
Interval 0.89 to 1.03
|
1.00 fold change
Interval 0.99 to 1.004
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Pre-Vaccination 1
|
0.14 titer
Interval 0.14 to 0.14
|
0.148 titer
Interval 0.139 to 0.158
|
0.141 titer
Interval 0.14 to 0.142
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 3
|
0.14 titer
Interval 0.14 to 0.14
|
0.140 titer
Interval 0.14 to 0.141
|
0.140 titer
Interval 0.14 to 0.141
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
0.14 titer
Interval 0.14 to 0.14
|
0.142 titer
Interval 0.14 to 0.143
|
0.140 titer
Interval 0.14 to 0.141
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
0.14 titer
Interval 0.14 to 0.14
|
0.143 titer
Interval 0.138 to 0.147
|
0.14 titer
Interval 0.14 to 0.14
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 3
|
0.14 titer
Interval 0.14 to 0.14
|
0.142 titer
Interval 0.138 to 0.147
|
0.145 titer
Interval 0.138 to 0.152
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
0.14 titer
Interval 0.14 to 0.14
|
0.143 titer
Interval 0.138 to 0.147
|
0.14 titer
Interval 0.14 to 0.14
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
0.14 titer
Interval 0.14 to 0.14
|
0.145 titer
Interval 0.135 to 0.157
|
0.146 titer
Interval 0.137 to 0.156
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
0.14 titer
Interval 0.14 to 0.14
|
0.143 titer
Interval 0.138 to 0.148
|
0.145 titer
Interval 0.138 to 0.152
|
|
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
0.141 titer
Interval 0.139 to 0.143
|
0.142 titer
Interval 0.138 to 0.147
|
0.14 titer
Interval 0.14 to 0.14
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
0 Participants
|
4 Participants
|
8 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
0 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
1.05 fold change
Interval 0.929 to 1.179
|
1.12 fold change
Interval 0.985 to 1.281
|
1.24 fold change
Interval 0.983 to 1.559
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
1.22 fold change
Interval 1.076 to 1.376
|
1.68 fold change
Interval 1.361 to 2.071
|
2.00 fold change
Interval 1.498 to 2.677
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
0.92 fold change
Interval 0.828 to 1.028
|
1.08 fold change
Interval 0.936 to 1.243
|
1.25 fold change
Interval 1.004 to 1.561
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
1.00 fold change
Interval 0.888 to 1.117
|
1.22 fold change
Interval 1.017 to 1.474
|
1.95 fold change
Interval 1.396 to 2.721
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
1.09 fold change
Interval 0.968 to 1.22
|
1.21 fold change
Interval 1.062 to 1.369
|
1.56 fold change
Interval 1.245 to 1.951
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
0.96 fold change
Interval 0.881 to 1.045
|
0.97 fold change
Interval 0.889 to 1.069
|
1.03 fold change
Interval 0.84 to 1.255
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Pre-Vaccination 1
|
266 titer
Interval 124.0 to 569.0
|
385 titer
Interval 241.0 to 614.0
|
298 titer
Interval 191.0 to 466.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
255 titer
Interval 123.0 to 528.0
|
375 titer
Interval 239.0 to 589.0
|
306 titer
Interval 197.0 to 476.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
278 titer
Interval 133.0 to 580.0
|
432 titer
Interval 284.0 to 657.0
|
365 titer
Interval 228.0 to 585.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
323 titer
Interval 148.0 to 707.0
|
646 titer
Interval 443.0 to 942.0
|
582 titer
Interval 375.0 to 904.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
245 titer
Interval 122.0 to 492.0
|
403 titer
Interval 245.0 to 663.0
|
350 titer
Interval 223.0 to 549.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
265 titer
Interval 131.0 to 533.0
|
458 titer
Interval 289.0 to 725.0
|
545 titer
Interval 336.0 to 884.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
289 titer
Interval 139.0 to 597.0
|
449 titer
Interval 288.0 to 698.0
|
436 titer
Interval 288.0 to 659.0
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
0 Participants
|
11 Participants
|
9 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
0 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
0 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
0.99 fold change
Interval 0.917 to 1.073
|
2.49 fold change
Interval 1.738 to 3.574
|
2.42 fold change
Interval 1.519 to 3.848
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
1.00 fold change
Interval 0.9 to 1.115
|
1.44 fold change
Interval 1.183 to 1.743
|
1.62 fold change
Interval 1.085 to 2.435
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
1.00 fold change
Interval 0.9 to 1.115
|
1.44 fold change
Interval 1.183 to 1.743
|
1.62 fold change
Interval 1.085 to 2.435
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
1.09 fold change
Interval 1.035 to 1.153
|
1.60 fold change
Interval 1.206 to 2.122
|
1.49 fold change
Interval 1.045 to 2.123
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
1.09 fold change
Interval 1.035 to 1.153
|
1.60 fold change
Interval 1.206 to 2.122
|
1.49 fold change
Interval 1.045 to 2.123
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
1.05 fold change
Interval 0.937 to 1.172
|
1.23 fold change
Interval 1.024 to 1.471
|
1.36 fold change
Interval 0.905 to 2.037
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Pre-Vaccination 1
|
96.9 titer
Interval 34.5 to 273.0
|
101 titer
Interval 74.2 to 137.0
|
109 titer
Interval 64.7 to 184.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
96.1 titer
Interval 33.4 to 277.0
|
251 titer
Interval 171.0 to 369.0
|
264 titer
Interval 163.0 to 428.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
97.1 titer
Interval 32.8 to 287.0
|
145 titer
Interval 104.0 to 201.0
|
171 titer
Interval 102.0 to 286.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
97.0 titer
Interval 33.8 to 279.0
|
189 titer
Interval 136.0 to 262.0
|
212 titer
Interval 128.0 to 350.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
106 titer
Interval 34.7 to 323.0
|
142 titer
Interval 101.0 to 201.0
|
172 titer
Interval 98.7 to 299.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
106 titer
Interval 37.7 to 297.0
|
163 titer
Interval 109.0 to 242.0
|
157 titer
Interval 91.7 to 268.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
102 titer
Interval 35.9 to 287.0
|
120 titer
Interval 88.1 to 164.0
|
143 titer
Interval 79.3 to 258.0
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
0.94 fold change
Interval 0.888 to 0.986
|
1.02 fold change
Interval 0.924 to 1.123
|
1.00 fold change
Interval 0.904 to 1.112
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
0.97 fold change
Interval 0.841 to 1.119
|
1.08 fold change
Interval 0.95 to 1.228
|
1.06 fold change
Interval 0.911 to 1.245
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
1.13 fold change
Interval 0.993 to 1.295
|
1.23 fold change
Interval 1.091 to 1.392
|
1.17 fold change
Interval 1.009 to 1.366
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
1.10 fold change
Interval 0.949 to 1.278
|
0.99 fold change
Interval 0.921 to 1.063
|
1.04 fold change
Interval 0.885 to 1.231
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
1.15 fold change
Interval 0.896 to 1.474
|
1.00 fold change
Interval 0.877 to 1.129
|
1.09 fold change
Interval 0.93 to 1.267
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
1.11 fold change
Interval 0.913 to 1.355
|
1.06 fold change
Interval 0.973 to 1.156
|
1.12 fold change
Interval 0.989 to 1.274
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
289 titer
Interval 112.0 to 742.0
|
347 titer
Interval 250.0 to 483.0
|
325 titer
Interval 226.0 to 466.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Pre-Vaccination 1
|
309 titer
Interval 117.0 to 815.0
|
341 titer
Interval 243.0 to 480.0
|
324 titer
Interval 214.0 to 491.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
299 titer
Interval 123.0 to 732.0
|
368 titer
Interval 272.0 to 499.0
|
350 titer
Interval 237.0 to 517.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
350 titer
Interval 137.0 to 896.0
|
420 titer
Interval 304.0 to 581.0
|
386 titer
Interval 257.0 to 577340.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
340 titer
Interval 135.0 to 854.0
|
347 titer
Interval 239.0 to 504.0
|
324 titer
Interval 209.0 to 503.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
355 titer
Interval 147.0 to 855.0
|
350 titer
Interval 238.0 to 513.0
|
337 titer
Interval 213.0 to 533.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
344 titer
Interval 141.0 to 837.0
|
377 titer
Interval 269.0 to 527.0
|
348 titer
Interval 220.0 to 553.0
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
0.96 fold change
Interval 0.897 to 1.028
|
1.15 fold change
Interval 1.006 to 1.316
|
0.99 fold change
Interval 0.886 to 1.114
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
0.95 fold change
Interval 0.822 to 1.102
|
1.14 fold change
Interval 0.99 to 1.318
|
0.95 fold change
Interval 0.845 to 1.065
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
1.13 fold change
Interval 0.987 to 1.288
|
1.17 fold change
Interval 1.024 to 1.34
|
1.15 fold change
Interval 0.952 to 1.379
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
1.19 fold change
Interval 0.967 to 1.468
|
1.26 fold change
Interval 1.071 to 1.481
|
1.30 fold change
Interval 1.043 to 1.614
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
1.27 fold change
Interval 1.055 to 1.539
|
1.16 fold change
Interval 0.951 to 1.421
|
1.24 fold change
Interval 1.006 to 1.524
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
1.20 fold change
Interval 1.0 to 1.433
|
1.12 fold change
Interval 0.95 to 1.316
|
1.05 fold change
Interval 0.886 to 1.234
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Pre-Vaccination 1
|
15.9 titer
Interval 7.822 to 32.3
|
20.0 titer
Interval 12.3 to 32.4
|
16.3 titer
Interval 10.6 to 25.1
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
15.3 titer
Interval 7.31 to 31.9
|
23.0 titer
Interval 14.9 to 35.4
|
16.2 titer
Interval 10.7 to 24.7
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
15.1 titer
Interval 7.659 to 29.9
|
22.8 titer
Interval 14.8 to 35.1
|
14.9 titer
Interval 9.867 to 22.4
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
17.9 titer
Interval 9.219 to 34.8
|
23.4 titer
Interval 14.8 to 37.1
|
17.1 titer
Interval 10.9 to 26.8
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
18.9 titer
Interval 9.873 to 36.3
|
23.0 titer
Interval 14.6 to 36.1
|
19.0 titer
Interval 11.8 to 30.6
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
20.2 titer
Interval 10.8 to 38.0
|
21.2 titer
Interval 13.8 to 32.5
|
18.1 titer
Interval 11.4 to 28.9
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
19.0 titer
Interval 9.965 to 36.3
|
22.2 titer
Interval 14.4 to 34.2
|
15.3 titer
Interval 9.576 to 24.5
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
0 Participants
|
3 Participants
|
8 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
0 Participants
|
12 Participants
|
14 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
0 Participants
|
8 Participants
|
14 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
0 Participants
|
10 Participants
|
15 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
0 Participants
|
14 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
0.78 fold change
Interval 0.68 to 0.883
|
1.05 fold change
Interval 0.867 to 1.281
|
1.38 fold change
Interval 0.986 to 1.944
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
0.86 fold change
Interval 0.757 to 0.967
|
1.42 fold change
Interval 1.126 to 1.786
|
2.04 fold change
Interval 1.326 to 3.148
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
1.26 fold change
Interval 1.117 to 1.411
|
2.51 fold change
Interval 1.97 to 3.198
|
3.82 fold change
Interval 2.571 to 5.674
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
0.85 fold change
Interval 0.717 to 0.997
|
2.05 fold change
Interval 1.521 to 2.766
|
3.61 fold change
Interval 2.281 to 5.717
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
0.91 fold change
Interval 0.783 to 1.057
|
2.38 fold change
Interval 1.72 to 3.291
|
4.69 fold change
Interval 3.036 to 7.258
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
0.95 fold change
Interval 0.778 to 1.165
|
3.22 fold change
Interval 2.216 to 4.678
|
5.07 fold change
Interval 3.354 to 7.65
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Pre-Vaccination 1
|
2469 titer
Interval 1707.0 to 3570.0
|
1990 titer
Interval 1459.0 to 2715.0
|
1903 titer
Interval 1456.0 to 2489.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 1: Day 7
|
1914 titer
Interval 1347.0 to 2720.0
|
2098 titer
Interval 1498.0 to 2938.0
|
2635 titer
Interval 1768.0 to 3926.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Pre-vaccination
|
2112 titer
Interval 1469.0 to 3036.0
|
2822 titer
Interval 2005.0 to 3972.0
|
3616 titer
Interval 2386.0 to 5479.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 2: Day 7
|
3099 titer
Interval 2077.0 to 4622.0
|
4996 titer
Interval 3666.0 to 6808.0
|
6429 titer
Interval 4459.0 to 9270.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Pre-vaccination
|
2087 titer
Interval 1377.0 to 3163.0
|
4205 titer
Interval 2794.0 to 6329.0
|
6030 titer
Interval 3861.0 to 9419.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Day 7
|
2246 titer
Interval 1498.0 to 3367.0
|
4877 titer
Interval 3159.0 to 7531.0
|
7839 titer
Interval 5185.0 to 11850.0
|
|
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Vaccination 3: Week 4
|
2350 titer
Interval 1499.0 to 3683.0
|
6267 titer
Interval 4283.0 to 9171.0
|
8458 titer
Interval 5780.0 to 12375.0
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
1 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
1.06 fold change
Interval 1.005 to 1.108
|
1.17 fold change
Interval 0.982 to 1.391
|
1.22 fold change
Interval 0.965 to 1.533
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
1.15 fold change
Interval 0.979 to 1.348
|
1.15 fold change
Interval 0.923 to 1.427
|
1.31 fold change
Interval 1.021 to 1.675
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
1.13 fold change
Interval 0.995 to 1.276
|
1.37 fold change
Interval 1.119 to 1.669
|
1.68 fold change
Interval 1.326 to 2.132
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
1.33 fold change
Interval 1.049 to 1.686
|
1.41 fold change
Interval 1.159 to 1.719
|
1.59 fold change
Interval 1.296 to 1.947
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
1.30 fold change
Interval 1.044 to 1.62
|
1.19 fold change
Interval 0.972 to 1.462
|
1.62 fold change
Interval 1.286 to 2.051
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
1.15 fold change
Interval 0.883 to 1.502
|
1.16 fold change
Interval 0.981 to 1.383
|
1.21 fold change
Interval 0.967 to 1.508
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Pre-Vaccination 1
|
633 titer
Interval 380.0 to 1055.0
|
748 titer
Interval 539.0 to 1037.0
|
646 titer
Interval 454.0 to 919.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 1: Day 7
|
668 titer
Interval 395.0 to 1131.0
|
874 titer
Interval 629.0 to 1215.0
|
785 titer
Interval 538.0 to 1147.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Pre-vaccination
|
727 titer
Interval 416.0 to 1270.0
|
858 titer
Interval 619.0 to 1190.0
|
856 titer
Interval 606.0 to 1210.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 2: Day 7
|
713 titer
Interval 411.0 to 1237.0
|
1022 titer
Interval 727.0 to 1436.0
|
1116 titer
Interval 765.0 to 1630.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Pre-vaccination
|
842 titer
Interval 484.0 to 1465.0
|
1159 titer
Interval 794.0 to 1691.0
|
1079 titer
Interval 754.0 to 1543.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Day 7
|
823 titer
Interval 476.0 to 1425.0
|
979 titer
Interval 654.0 to 1467.0
|
1103 titer
Interval 750.0 to 1622.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Vaccination 3: Week 4
|
729 titer
Interval 394.0 to 1350.0
|
885 titer
Interval 628.0 to 1247.0
|
820 titer
Interval 561.0 to 1200.0
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
0.96 fold change
Interval 0.841 to 1.094
|
0.94 fold change
Interval 0.872 to 1.011
|
0.84 fold change
Interval 0.753 to 0.94
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
0.99 fold change
Interval 0.815 to 1.206
|
0.96 fold change
Interval 0.878 to 1.039
|
0.90 fold change
Interval 0.802 to 1.006
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
1.19 fold change
Interval 1.066 to 1.328
|
1.14 fold change
Interval 1.049 to 1.234
|
1.00 fold change
Interval 0.923 to 1.086
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
1.01 fold change
Interval 0.846 to 1.206
|
0.97 fold change
Interval 0.901 to 1.049
|
0.84 fold change
Interval 0.751 to 0.934
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
1.04 fold change
Interval 0.898 to 1.203
|
0.94 fold change
Interval 0.874 to 1.019
|
0.88 fold change
Interval 0.776 to 1.0
|
|
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
0.97 fold change
Interval 0.828 to 1.137
|
0.95 fold change
Interval 0.873 to 1.038
|
0.89 fold change
Interval 0.764 to 1.041
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Pre-Vaccination 1
|
1610 titer
Interval 1061.0 to 2442.0
|
1265 titer
Interval 955.0 to 1677.0
|
1809 titer
Interval 1262.0 to 2592.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 1: Day 7
|
1544 titer
Interval 972.0 to 2452.0
|
1188 titer
Interval 893.0 to 1581.0
|
1522 titer
Interval 1109.0 to 2088.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Pre-vaccination
|
1597 titer
Interval 958.0 to 2662.0
|
1208 titer
Interval 901.0 to 1620.0
|
1712 titer
Interval 1218.0 to 2408.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 2: Day 7
|
1915 titer
Interval 1203.0 to 3050.0
|
1439 titer
Interval 1064.0 to 1946.0
|
1939 titer
Interval 1349.0 to 2787.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Pre-vaccination
|
1627 titer
Interval 1063.0 to 2490.0
|
1317 titer
Interval 975.0 to 1780.0
|
1648 titer
Interval 1140.0 to 2382.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Day 7
|
1673 titer
Interval 1113.0 to 2515.0
|
1278 titer
Interval 953.0 to 1713.0
|
1733 titer
Interval 1173.0 to 2562.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Vaccination 3: Week 4
|
1563 titer
Interval 992.0 to 2462.0
|
1236 titer
Interval 936.0 to 1630.0
|
1754 titer
Interval 1191.0 to 2584.0
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Defined as a 2.5-fold rise or greater in geometric mean titer.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
1 Participants
|
9 Participants
|
5 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
3 Participants
|
6 Participants
|
10 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
2 Participants
|
7 Participants
|
5 Participants
|
|
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
2 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
0.80 fold change
Interval 0.626 to 1.025
|
0.96 fold change
Interval 0.785 to 1.165
|
1.00 fold change
Interval 0.789 to 1.257
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
0.76 fold change
Interval 0.567 to 1.012
|
1.10 fold change
Interval 0.898 to 1.352
|
1.01 fold change
Interval 0.704 to 1.457
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
1.38 fold change
Interval 1.125 to 1.695
|
1.65 fold change
Interval 1.232 to 2.205
|
1.58 fold change
Interval 1.156 to 2.169
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
1.57 fold change
Interval 1.161 to 2.119
|
1.49 fold change
Interval 1.132 to 1.967
|
2.20 fold change
Interval 1.293 to 3.745
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
1.45 fold change
Interval 1.146 to 1.83
|
1.58 fold change
Interval 1.22 to 2.045
|
1.77 fold change
Interval 1.08 to 2.902
|
|
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
1.38 fold change
Interval 1.011 to 1.874
|
1.57 fold change
Interval 1.164 to 2.108
|
1.61 fold change
Interval 1.073 to 2.417
|
PRIMARY outcome
Timeframe: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=24 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Pre-Vaccination 1
|
36.2 titer
Interval 20.5 to 63.9
|
68.2 titer
Interval 40.1 to 116.0
|
54.3 titer
Interval 34.4 to 85.7
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 1: Day 7
|
29.0 titer
Interval 16.0 to 52.7
|
65.2 titer
Interval 35.2 to 121.0
|
54.1 titer
Interval 31.7 to 92.1
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Pre-vaccination
|
27.4 titer
Interval 14.2 to 52.9
|
75.1 titer
Interval 42.2 to 134.0
|
52.9 titer
Interval 30.6 to 91.6
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 2: Day 7
|
50.0 titer
Interval 26.5 to 94.4
|
112 titer
Interval 69.0 to 183.0
|
85.7 titer
Interval 54.2 to 136.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Pre-vaccination
|
56.8 titer
Interval 26.9 to 120.0
|
115 titer
Interval 68.0 to 195.0
|
118 titer
Interval 72.0 to 194.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Day 7
|
52.5 titer
Interval 27.8 to 98.9
|
122 titer
Interval 70.2 to 212.0
|
95.2 titer
Interval 51.4 to 176.0
|
|
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Vaccination 3: Week 4
|
49.9 titer
Interval 29.4 to 84.7
|
113 titer
Interval 68.4 to 185.0
|
86.6 titer
Interval 50.8 to 148.0
|
PRIMARY outcome
Timeframe: 5 daysSevere diarrhea was defined as \>800 grams of grade 3-5 stools passed over the 120-hour observation period. For episodes starting at or before 120 hours post-challenge, volunteers were followed to resolution and the total stool output weight was considered in determining whether a specific volunteer met the primary definition of severe diarrhea. The end of a diarrheal episode occurred when a volunteer did not pass any grade 3-5 stool in a 24-hour period. Grades were defined as follows: Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain
Not severe
|
6 Participants
|
10 Participants
|
10 Participants
|
|
Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain
Severe
|
7 Participants
|
3 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 1: Day 0
|
21 Participants
|
23 Participants
|
10 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 1: Day 3
|
24 Participants
|
23 Participants
|
10 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 1: Day 7
|
24 Participants
|
23 Participants
|
10 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 2: Day 0
|
22 Participants
|
21 Participants
|
11 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 2: Day 3
|
21 Participants
|
20 Participants
|
9 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 2: Day 7
|
21 Participants
|
21 Participants
|
9 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 3: Day 0
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 3: Day 7
|
18 Participants
|
21 Participants
|
10 Participants
|
|
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Vaccination 3: Day 28
|
20 Participants
|
20 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3Population: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 1: Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 1: Day 3
|
22 Participants
|
16 Participants
|
0 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 1: Day 7
|
11 Participants
|
3 Participants
|
1 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 2: Day 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 2: Day 3
|
14 Participants
|
12 Participants
|
0 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 2: Day 7
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 3: Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 3: Day 7
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Part A: Number of Participants With Positive Shedding Results for ACE527
Vaccination 3: Day 28
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 days after the first and second vaccinationsPopulation: Subjects who received the vaccination and had valid test results.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Number of Participants Shedding Vaccine Strains Included in ACE527
ACAM2022 strain: Vaccination 1
|
9 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants Shedding Vaccine Strains Included in ACE527
ACAM2022 strain: Vaccination 2
|
4 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants Shedding Vaccine Strains Included in ACE527
ACAM2025 strain: Vaccination 1
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Shedding Vaccine Strains Included in ACE527
ACAM2025 strain: Vaccination 2
|
5 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants Shedding Vaccine Strains Included in ACE527
ACAM2027 strain: Vaccination 1
|
17 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants Shedding Vaccine Strains Included in ACE527
ACAM2027 strain: Vaccination 2
|
12 Participants
|
11 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 daysDefined as mild, moderate, or severe diarrhea, specifically: * Mild diarrhea: 2 or 3grade 3-5 stools totaling 200 g - 400 g, or 1 grade 3-5 stool of \>300 g * Moderate diarrhea: 4-5 grade 3-5 stools totaling \>200 g or 401 - 800g * Severe diarrhea: \> 800g grade 3-5 stool(s) Grades were defined as follows: Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity
None
|
3 Participants
|
9 Participants
|
8 Participants
|
|
Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity
Mild
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity
Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity
Severe
|
7 Participants
|
3 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 5 daysGrades were defined as follows: Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer
|
1655.1 grams
Standard Deviation 1743.1
|
748.8 grams
Standard Deviation 1574.6
|
1878.2 grams
Standard Deviation 1729.4
|
SECONDARY outcome
Timeframe: 5 daysGrades were defined as follows: Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer
|
859 grams
Interval 522.0 to 3224.0
|
30 grams
Interval 0.0 to 858.0
|
1400 grams
Interval 547.0 to 2713.0
|
SECONDARY outcome
Timeframe: 5 daysGrades were defined as follows: Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer
|
11.7 stools
Standard Deviation 9.61
|
6.0 stools
Standard Deviation 9.68
|
10.8 stools
Standard Deviation 7.99
|
SECONDARY outcome
Timeframe: 5 daysGrades were defined as follows: Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer
|
14 stools
Interval 0.0 to 27.0
|
1 stools
Interval 0.0 to 11.0
|
12 stools
Interval 3.0 to 16.0
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Participants in Part A of the study who received at least one dose of the study product.
Solicited reactions were generally graded as mild if there was discomfort, but no disruption of normal daily activities; moderate if if discomfort was sufficient to affect normal daily activity and partially relieved with symptomatic treatment; severe if discomfort was sufficient to affect normal daily activity considerably, prevent regular activity, and not relieved with symptomatic treatment.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Nausea
|
3 Participants
|
2 Participants
|
9 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Vomiting
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Abdominal Pain
|
0 Participants
|
4 Participants
|
13 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Urgency of Defecation
|
1 Participants
|
2 Participants
|
13 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Borborygmus (gurgling)
|
2 Participants
|
3 Participants
|
15 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Malaise
|
3 Participants
|
3 Participants
|
11 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Headache
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Anorexia
|
4 Participants
|
2 Participants
|
14 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Myalgia
|
0 Participants
|
1 Participants
|
6 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Chills
|
2 Participants
|
2 Participants
|
8 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Temperature
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
Any reaction
|
8 Participants
|
8 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 5 daysWhen asking about adverse events, subjects were asked whether their illness resulting from ETEC would have reduced their daily activity because of their illness if they had been vacationing or traveling on business.
Outcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
Stayed in bed · No
|
9 Participants
|
10 Participants
|
14 Participants
|
|
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
Changed planned activities · No
|
9 Participants
|
8 Participants
|
10 Participants
|
|
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
Changed planned activities · Yes
|
4 Participants
|
5 Participants
|
21 Participants
|
|
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
Stayed in bed · Yes
|
4 Participants
|
3 Participants
|
17 Participants
|
|
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
Either of the above · No
|
7 Participants
|
8 Participants
|
10 Participants
|
|
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
Either of the above · Yes
|
6 Participants
|
5 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Among subjects who met the protocol definition of diarrhea over the observation period
Defined as mild, moderate, or severe diarrhea, specifically: * Mild diarrhea: 2 or 3grade 3-5 stools totaling 200 g - 400 g, or 1 grade 3-5 stool of \>300 g * Moderate diarrhea: 4-5 grade 3-5 stools totaling \>200 g or 401 - 800g * Severe diarrhea: \> 800g grade 3-5 stool(s) Grades were defined as follows: Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container
Outcome measures
| Measure |
Part A: ACE527 Alone
n=10 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=4 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=23 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea
|
51.5 hours
Standard Deviation 26.88
|
59.9 hours
Standard Deviation 27.12
|
46.4 hours
Standard Deviation 20.35
|
SECONDARY outcome
Timeframe: 2 days after vaccinationOutcome measures
| Measure |
Part A: ACE527 Alone
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=12 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=29 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge
|
261.30 colony forming units
Standard Deviation 391.5
|
94.345 colony forming units
Standard Deviation 199.1
|
154.84 colony forming units
Standard Deviation 321.4
|
SECONDARY outcome
Timeframe: 5 daysOutcome measures
| Measure |
Part A: ACE527 Alone
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=13 Participants
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=31 Participants
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
|---|---|---|---|
|
Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids
Early antibiotic treatment · No
|
7 Participants
|
11 Participants
|
13 Participants
|
|
Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids
Early antibiotic treatment · Yes
|
6 Participants
|
2 Participants
|
18 Participants
|
|
Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids
IV fluids · No
|
9 Participants
|
9 Participants
|
16 Participants
|
|
Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids
IV fluids · Yes
|
4 Participants
|
4 Participants
|
15 Participants
|
Adverse Events
Part A: ACE527 Alone
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part A: ACE527 Plus dmLT
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part A: Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B: ACE527 Alone
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: ACE527 Plus dmLT
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B: Control
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: ACE527 Alone
n=24 participants at risk
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 participants at risk
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 participants at risk
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
Part B: ACE527 Alone
n=13 participants at risk；n=12 participants at risk
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
|
Part B: ACE527 Plus dmLT
n=13 participants at risk；n=12 participants at risk
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
|
Part B: Control
n=31 participants at risk
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series), plus additional participants who did not participate in Part A.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fractured Right Wrist
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
Other adverse events
| Measure |
Part A: ACE527 Alone
n=24 participants at risk
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
|
Part A: ACE527 Plus dmLT
n=24 participants at risk
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
|
Part A: Placebo
n=12 participants at risk
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
|
Part B: ACE527 Alone
n=13 participants at risk；n=12 participants at risk
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
|
Part B: ACE527 Plus dmLT
n=13 participants at risk；n=12 participants at risk
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series).
|
Part B: Control
n=31 participants at risk
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months and participated in Part B of the study (received fully virulent H10407 strain 5-7 months after the three-dose vaccination series), plus additional participants who did not participate in Part A.
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
15.4%
2/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
23.1%
3/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
16.1%
5/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
20.8%
5/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
15.4%
2/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
6.5%
2/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
6.5%
2/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Eructation
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
33.3%
8/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
23.1%
3/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
12.9%
4/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
General disorders
Asthenia
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
General disorders
Fatigue
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
General disorders
Tenderness
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Immune system disorders
Allergy to metals
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Infections and infestations
Staphylococcal infection
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
4/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
16.7%
4/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Injury, poisoning and procedural complications
Laceration
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Investigations
Haemoglobin decreased
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
12.5%
3/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Investigations
White blood cell count decreased
|
8.3%
2/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Investigations
White blood cell count increased
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
2/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
23.1%
3/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
2/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
15.4%
2/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
2/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
7.7%
1/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
6.5%
2/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
4.2%
1/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
2/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
3.2%
1/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
8.3%
1/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/24 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/12 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
15.4%
2/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
0.00%
0/13 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
22.6%
7/31 • 1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60