Live Attenuated ETEC Vaccine ACE527 With and Without dmLT... | NCT01739231 | Trialant
NCT01739231
Sponsor
PATH
Status
Completed
Last Update Posted
Feb 12, 2019Actual
Enrollment
81Actual
Phase
Phase 1Phase 2
Conditions
Diarrhea
Interventions
ACE527
dmLT
CeraVacx placebo
H10407 challenge strain
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01739231
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VAC 006
Secondary IDs
Not provided
Brief Title
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
Official Title
Safety, Reactogenicity, Tolerability, Immunogenicity and Efficacy of Live Attenuated ETEC ACE527 Vaccine Administered Alone or With a Double Mutant E. Coli Heat Labile Toxin (dmLT) in Healthy Adult Volunteers
Acronym
Not provided
Organization
PATHOTHER
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2012
Primary Completion Date
Oct 2013Actual
Completion Date
Jan 2014Actual
First Submitted Date
Sep 21, 2012
First Submission Date that Met QC Criteria
Nov 28, 2012
First Posted Date
Dec 3, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 6, 2015
Results First Submitted that Met QC Criteria
Nov 27, 2018
Results First Posted Date
Dec 21, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 25, 2019
Last Update Posted Date
Feb 12, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PATHOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children living in developing countries and in travelers to those countries. This research study is also testing an investigational adjuvant called dmLT. An adjuvant is something that is added to a vaccine to make it work better. The purpose of this study is two-fold. First, Part A aims to find out if the vaccine by itself or the vaccine combined with the adjuvant is safe, tolerable, and initiates an immune response. Second, Part B aims to find out if the vaccine by itself or the vaccine combined with the adjuvant prevents diarrheal disease when challenged with ETEC H10407. About 60 healthy adults, ages 18-50, will participate in Part A, and they will be required to stay in the research facility for several nights for the first dose, but will not be required to stay overnight for the second and third doses. Participants will be assigned to receive either the vaccine alone, the vaccine with adjuvant, or placebo by mouth. Study procedures include: stool samples, blood samples, and documentation of side effects. Participants will be involved in study related procedures for about 8 months.
Interested volunteers from Part A will along with volunteers who were never vaccinated in Part A will return to participate in Part B. These volunteers will be required to stay overnight in the research facility for several nights after challenge, after which they will be treated with antibiotics and sent home. Study procedures include stool samples, blood samples, and documentation of infection with ETEC H10407. If the vaccine with/without adjuvant is effective, the volunteers should not development diarrhea, but if the vaccine with/without adjuvant is not effective, the volunteers will have diarrhea for a few days.
Detailed Description
This study is a clinical trial in healthy adult volunteers to evaluate the safety, immunogenicity and efficacy of a live attenuated ETEC vaccine, ACE527, with and without a mucosal adjuvant, dmLT. This study was designed initially as a single site, Phase 1, double-blind, randomized, placebo-controlled, clinical trial in healthy adult volunteers to evaluate the safety and immunogenicity of a live attenuated ETEC vaccine, ACE527, with and without a mucosal adjuvant, dmLT (Part A). The addition of a challenge step provides a unique opportunity to evaluate the efficacy of the new lyophilized formulation of ACE527 vaccine, given in a two or three dose regimen, with and without dmLT, against wild type ETEC strain H10407 challenge (designated as Part B: Phase 2b Open Label Challenge Study). In addition, challenging the volunteers may allow for the identification of immune correlates of protection, taking advantage of newly available technologies (immune proteomics, transcriptomics, etc.)
ACE527 comprises three genetically attenuated and engineered strains of E. coli, with antigen profiles covering a wide range of ETEC surface colonization factor antigens (CFA/I, CFA/II [CS1, CS2, CS3] and CFA/IV [CS5, CS6]) and also expressing LT-B, the inactive subunit of LT (ETEC heat labile toxin). LT(R192G/L211A), or dmLT, is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine.
Volunteers were enrolled in Part A into each of two separate Cohorts. Cohort 1 and 2 volunteers received 10^10 colony-forming units (cfu) total dose of ACE527, 10^10 cfu total dose of ACE527 with 25 µg dmLT, or placebo at 0, 1, and 2 months. Enrollment and dosing of Cohort 2 was dependent on an acceptable safety profile of the first dose of Cohort 1, based on evaluation of data up until Day 3 by the Safety Review Committee (SRC). The first immunization of each Cohort was administered in the Center for Immunization Research (CIR) Inpatient Unit, followed by 72 hours of direct post-immunization observation. The SRC met after the first dose of cohort to determine continuation of volunteer dosing on an outpatient basis, and enrollment of Cohort 2. The SRC met again after the first dose of Cohort 2 after concluding that the first dose appeared safe and well tolerated, subsequent doses would be administered on an outpatient basis. Safety was assessed by solicited symptoms/subject memory aid and laboratory evaluations. Adverse events (AE)s were graded according to standardized criteria. The immunogenicity outcome measures of interest include serum immunoglobulin G (IgG) and immunoglobulin A (IgA) antibodies by enzyme-linked immunosorbent assay (ELISA) against all vaccine antigens, cytokine assays, B and T cell memory responses, shedding profile of ACE527, and vaccine specific mucosal IgA responses.
Part B challenge cohorts were recruited among those participating in Part A; plus additional unvaccinated control volunteers sufficient to enroll up to a total of 60 recruited, as needed. Volunteers in the Phase 2b study were enrolled and challenged in 2-4 cohorts due to the CIR Inpatient Unit capacity of 30 beds. A minimum of 8-10 controls were challenged with each cohort of vaccinees to ensure comparability of attack rates across challenge cohorts. Volunteers were admitted as inpatients and challenged, with approximately 2 x 10^7 cfu of the fully virulent ETEC strain, H10407, followed by 5 days of direct observation. A Data Review Committee (DRC) will be convened to review the clinical data for all challenged volunteers and verify all outcomes per protocol definitions before any vaccine efficacy assessments were made.
Conditions Module
Conditions
Diarrhea
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
81Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ACE527 alone
Experimental
In Part A of the study, subjects were split into two cohorts whereby enrollment of the second cohort depended on the safety profile of the first cohort. 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.
Biological: ACE527
Biological: H10407 challenge strain
ACE527 plus dmLT
Experimental
In Part A of the study, subjects were split into two cohorts whereby enrollment of the second cohort depended on the safety profile of the first cohort. 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.
Biological: ACE527
Biological: dmLT
Biological: H10407 challenge strain
Control: Part A and B
Active Comparator
In Part A of the study, subjects were split into two cohorts whereby enrollment of the second cohort depended on the safety profile of the first cohort. 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 were administered H10407 challenge strain 5-7 months after the three-dose vaccination series.
Biological: CeraVacx placebo
Biological: H10407 challenge strain
Control: Part B only
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACE527
Biological
3x10^9 cfu ACE527 vaccine strain. Comprised of three genetically attenuated and engineered strains of E. coli, with antigen profiles covering a wide range of ETEC surface colonization factor antigens (CFA/I, CFA/II [CS1, CS2, CS3] and CFA/IV [CS5, CS6]) and also expressing LTB, the inactive subunit of LT (ETEC heat labile toxin). The constituent strains of ACE527 were:
ACAM2025: a live, attenuated, CFA/I, LTB positive strain
ACAM2022: a live, attenuated, CS5, CS6, LTB positive strain, and
ACAM2027: a live, attenuated, CS1, CS2, CS3, LTB positive strain.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal
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.
up to 1 month after last vaccination (3 months)
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
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.
up to 1 month after last vaccination (3 months)
Part A: Number of Solicited Reactions
Solicited reactions were collected 1 week after each vaccination.
up to 1 week after each vaccination (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)
Defined as a four-fold rise or greater in geometric mean titer.
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
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)
Secondary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3
Part A: Number of Participants With Positive Shedding Results for ACE527
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female healthy adults between 18 and 50 years of age at the time of enrollment.
General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI.
Negative pregnancy test at screening and before the first (V0), second (V28), and third vaccinations (V56) for female volunteers of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female volunteers unable to bear children must have this documented (e.g. tubal ligation or hysterectomy) or must have negative pregnancy tests.
Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
Completion of a training session and demonstrated comprehension of the protocol procedures and knowledge of ETEC associated illness by passing a written examination (70% pass score).
Availability for the study duration, including all planned follow-up visits.
Received at least 2 doses of ACE527 vaccine alone or in combination with 25 ug dmLT 4-6 months prior to challenge (Part B only)
Exclusion Criteria:
Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might include stable asthma controlled with inhalers or mild hypertension stably controlled with a single agent.
Significant abnormalities in screening hematology, or serum chemistry as determined by PI or PI in consultation with the Medical Officer and sponsor.
Presence in the serum of HIV antibody, HBsAg, or HCV antibody.
Evidence of IgA deficiency (serum IgA < 7 mg/dl or limit of detection of assay).
Evidence of current excessive alcohol consumption or drug dependence.
Volunteers whose Body Mass Index (BMI) is less than 19.0 or greater than 34.0 (kg/m2)
Recent vaccination or receipt of an investigational product (within 30 days before vaccination).
Intention to donate blood or blood products within one month following the completion of study participation (note: The Red Cross will not allow blood donations for 1 year following participation in an investigational research study).
Any other criteria which, in the investigator's opinion, would compromise the ability of the volunteer to participate in the study, the safety of the study, or the results of the study
Working as a food handler, in child-care or as a healthcare worker with direct patient contact.
Have household contacts who are <2 years old or >80 years old or infirm or immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).
Abnormal stool pattern (fewer than 3 per week or more than 3 per day).
Regular (≥ weekly) use of laxatives, antacids, or other agents to lower stomach acidity.
Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding the first vaccination or planned use during the active study period.
Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within two years prior to dosing, OR planned travel to endemic countries during the length of the study.
Vaccination for or ingestion of ETEC, cholera, or LT toxin within 3 years prior to dosing.
Use of antibiotics during the 7 days before dosing or proton pump inhibitors, H2 blockers or antacids within 48hours prior to dosing.
History of diarrhea in the 7 days prior to vaccination (outpatient diarrhea is defined as ≥ 3 unformed (grade 3 or greater) loose stools in 24 hours).
Known allergy to two of the three following antibiotics: Ciprofloxacin, amoxicillin, and/or trimethoprim/sulfamethoxazole
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clayton D Harro, MD, ScM
Johns Hopkins Bloomberg School of Public Health
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Center for Immunization Research (CIR) at Johns Hopkins School of Public Health (JHSPH)
Harro C, Louis Bourgeois A, Sack D, Walker R, DeNearing B, Brubaker J, Maier N, Fix A, Dally L, Chakraborty S, Clements JD, Saunders I, Darsley MJ. Live attenuated enterotoxigenic Escherichia coli (ETEC) vaccine with dmLT adjuvant protects human volunteers against virulent experimental ETEC challenge. Vaccine. 2019 Mar 28;37(14):1978-1986. doi: 10.1016/j.vaccine.2019.02.025. Epub 2019 Feb 21.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
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.
FG002
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.
FG003
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.
Periods
Title
Milestones
Reasons Not Completed
Part A
Type
Comment
Milestone Data
STARTED
FG00024 subjects
FG00124 subjects
FG00212 subjects
FG0030 subjects
Received All 3 Vaccinations
FG00021 subjects
FG00120 subjects
FG00212 subjects
FG0030 subjects
COMPLETED
FG00020 subjects
FG00117 subjects
FG00212 subjects
FG0030 subjects
NOT COMPLETED
FG0004 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
Part B
Type
Comment
Milestone Data
STARTED
FG00020 subjects
FG00117 subjects
FG00212 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
BG001
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
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.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal
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.
Participants in Part A of the study who received at least one dose of the study product.
Posted
Number
adverse events
up to 1 month after last vaccination (3 months)
ID
Title
Description
OG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG001
Part A: ACE527 Plus dmLT
Adverse Events Module
Frequency Threshold
0
Time Frame
1 month after each vaccination in Part A (total of three months); 1 month after challenge dose in Part B.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fractured Right Wrist
Injury, poisoning and procedural complications
MedDRA (10.0)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bradycardia
Cardiac disorders
MedDRA (10.0)
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Richard Walker
PATH
202-822-0033
rwalker@path.org
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D003967
Diarrhea
Ancestor Terms
ID
Term
D012817
Signs and Symptoms, Digestive
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Part A of the study was masked to the participant, care provider, investigator, and outcomes assessor. Part B was open label.
Eligible participants were screened and administered H10407 challenge strain concurrently with other arms in Part B of the study. Their results for Part B are combined with that of the Control Arm in Part A, which received three oral doses of CeraVacx placebo.
Biological: H10407 challenge strain
ACE527 alone
ACE527 plus dmLT
dmLT
Biological
A derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine (13). These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
ACE527 plus dmLT
LT(R192G/L211A)
CeraVacx placebo
Biological
CeraVacx® is used to neutralize gastric acidity upon ingestion of vaccine. It was also used as the placebo in this study. CeraVacx® was prepared from the commercial product (Cera Products, Inc.); 9.5 grams were added to sterile water for each dose and mixed. Each dose contained 7 grams of rice syrup, 2 grams of sodium bicarbonate, and 0.5 grams of trisodium citrate.
Control: Part A and B
H10407 challenge strain
Biological
Approximately 2 x 10^7 cfu of the fully virulent ETEC strain. Previously administered to 91 volunteers at this challenge dose by the CIR clinical team over the previous 4 years in conjunction with other Phase 1/2b trials.
ACE527 alone
ACE527 plus dmLT
Control: Part A and B
Control: Part B only
ST+, LT+, CFA/I toxin
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
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 and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
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)
Defined as a four-fold rise or greater in geometric mean titer.
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
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 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
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 and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
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)
Defined as a four-fold rise or greater in geometric mean titer.
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
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 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Pre all vaccinations; day 3 post-vaccination 1 and 2; day 7 post all vaccinations; 4 weeks post-vaccination 3
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)
Defined as a four-fold rise or greater in geometric mean titer.
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
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 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
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)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
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)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain
Severe 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
5 days
Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3
Number of Participants Shedding Vaccine Strains Included in ACE527
3 days after the first and second vaccinations
Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity
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
5 days
Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer
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
5 days
Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer
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
5 days
Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer
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
5 days
Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer
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
5 days
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
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.
1 week
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
When 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.
5 days
Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea
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
5 days
Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge
2 days after vaccination
Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids
5 days
21 subjects
Challenged
FG00013 subjects
FG00113 subjects
FG00210 subjects
FG00321 subjects
COMPLETED
FG00013 subjects
FG00112 subjects
FG00210 subjects
FG00319 subjects
NOT COMPLETED
FG0007 subjects
FG0015 subjects
FG0022 subjects
FG0032 subjects
BG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
BG003
Part B: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months and participated in Part B of the study.
BG004
Part B: ACE527 Plus dmLT
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.
BG005
Part B: Control
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.
BG006
Total
Total of all reporting groups
24
BG00124
BG00212
BG00313
BG00413
BG00531
BG006117
Mean
Full Range
years
Title
Denominators
Categories
Part A
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG00212
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00660
Title
Measurements
BG00035.8(21 to 48)
BG00137.6(19 to 49)
BG00237.0(26 to 49)
BG006
Part B
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG00313
Sex: Female, Male
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.
Count of Participants
Participants
Title
Denominators
Categories
Part A
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG00212
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00660
Title
Measurements
Female
BG0007
BG0019
BG0021
BG003
Part B
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG00313
Ethnicity (NIH/OMB)
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.
Count of Participants
Participants
Title
Denominators
Categories
Part A
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG00212
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00660
Title
Measurements
Hispanic or Latino
BG0002
BG0011
BG0021
BG003
Part B
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG00313
Race (NIH/OMB)
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.
Count of Participants
Participants
Title
Denominators
Categories
Part A
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG00212
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00660
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG0020
BG006
Part B
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG00313
Height
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.
Mean
Full Range
inches
Title
Denominators
Categories
Part A
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG00212
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00660
Title
Measurements
BG00069.4(59 to 76)
BG00167.4(61 to 73)
BG00269.1(65 to 73)
BG006
Part B
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG00313
Weight
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.
Mean
Full Range
pounds
Title
Denominators
Categories
Part A
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG00212
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00660
Title
Measurements
BG000190.3(127 to 242)
BG001171.7(119 to 223)
BG002176.2(150 to 232)
BG006
Part B
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG00313
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
OG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
Units
Counts
Participants
OG00024
OG00124
OG00212
Title
Denominators
Categories
Serious adverse event
Title
Measurements
OG0000
OG0010
OG0020
Adverse event leading to withdrawal
Title
Measurements
OG0000
OG0011
OG0020
Primary
Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination
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.
Participants in Part A of the study who received at least one dose of the study product.
Posted
Count of Participants
Participants
up to 1 month after last vaccination (3 months)
ID
Title
Description
OG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG001
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
OG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
Units
Counts
Participants
OG00024
OG00124
OG00212
Title
Denominators
Categories
Not related: Mild
Title
Measurements
OG00010
OG0019
OG0024
Not related: Moderate
Primary
Part A: Number of Solicited Reactions
Solicited reactions were collected 1 week after each vaccination.
Participants in Part A of the study who received at least one dose of the study product.
Posted
Count of Participants
Participants
up to 1 week after each vaccination (at 0, 1, and 2 months)
ID
Title
Description
OG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG001
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
OG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
Units
Counts
Participants
OG00024
OG00124
OG00212
Title
Denominators
Categories
Fever
Title
Measurements
OG0001
OG0012
OG0020
Nausea
Primary
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)
Defined as a four-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Defined as a four-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Defined as a four-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre all vaccinations; day 3 post-vaccination 1 and 2; day 7 post all vaccinations; 4 weeks post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Defined as a four-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 3
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
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)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Defined as a 2.5-fold rise or greater in geometric mean titer.
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
fold change
Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Vaccination 1: Day 7
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Subjects who received the vaccination and had valid test results.
Posted
Geometric Mean
95% Confidence Interval
titer
Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
OG001
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG002
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
Units
Counts
Participants
OG00012
OG00124
OG00224
Title
Denominators
Categories
Pre-Vaccination 1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00224
Title
Measurements
Primary
Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain
Severe 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
Posted
Count of Participants
Participants
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Title
Measurements
Not severe
OG0006
OG00110
OG00210
Severe
Secondary
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG001
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
OG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
Units
Counts
Participants
OG00024
OG00124
OG00212
Title
Denominators
Categories
Vaccination 1: Day 0
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00212
Title
Measurements
Secondary
Part A: Number of Participants With Positive Shedding Results for ACE527
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3
ID
Title
Description
OG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG001
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
OG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
Units
Counts
Participants
OG00024
OG00124
OG00212
Title
Denominators
Categories
Vaccination 1: Day 0
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00212
Title
Measurements
Secondary
Number of Participants Shedding Vaccine Strains Included in ACE527
Subjects who received the vaccination and had valid test results.
Posted
Count of Participants
Participants
3 days after the first and second vaccinations
ID
Title
Description
OG000
Part A: ACE527 Alone
Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months.
OG001
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
OG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
Units
Counts
Participants
OG00024
OG00124
OG00212
Title
Denominators
Categories
ACAM2022 strain: Vaccination 1
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00212
Title
Measurements
Secondary
Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity
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
Posted
Count of Participants
Participants
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Title
Measurements
None
OG0003
OG0019
OG0028
Mild
Secondary
Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer
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
Posted
Mean
Standard Deviation
grams
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Title
Measurements
OG0001655.1± 1743.1
OG001748.8± 1574.6
OG0021878.2± 1729.4
Secondary
Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer
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
Posted
Mean
Inter-Quartile Range
grams
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Title
Measurements
OG000859(522 to 3224)
OG00130(0 to 858)
OG0021400(547 to 2713)
Secondary
Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer
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
Posted
Mean
Standard Deviation
stools
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Title
Measurements
OG00011.7± 9.61
OG0016.0± 9.68
OG00210.8± 7.99
Secondary
Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer
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
Posted
Median
Inter-Quartile Range
stools
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Title
Measurements
OG00014(0 to 27)
OG0011(0 to 11)
OG00212(3 to 16)
Secondary
Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe
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.
Participants in Part A of the study who received at least one dose of the study product.
Posted
Count of Participants
Participants
1 week
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Placebo
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Nausea
Title
Measurements
OG0003
OG0012
OG0029
Vomiting
Secondary
Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity
When 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.
Posted
Count of Participants
Participants
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Changed planned activities
Title
Measurements
No
OG0009
OG0018
OG00210
Yes
Secondary
Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea
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
Among subjects who met the protocol definition of diarrhea over the observation period
Posted
Mean
Standard Deviation
hours
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00010
OG0014
OG00223
Title
Denominators
Categories
Title
Measurements
OG00051.5± 26.88
OG00159.9± 27.12
OG00246.4± 20.35
Secondary
Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge
Posted
Mean
Standard Deviation
colony forming units
2 days after vaccination
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00012
OG00112
OG00229
Title
Denominators
Categories
Title
Measurements
OG000261.30± 391.5
OG00194.345± 199.1
OG002154.84± 321.4
Secondary
Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids
Posted
Count of Participants
Participants
5 days
ID
Title
Description
OG000
Part B: ACE527 Alone
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).
OG001
Part B: ACE527 Plus dmLT
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).
OG002
Part B: Control
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.
Units
Counts
Participants
OG00013
OG00113
OG00231
Title
Denominators
Categories
Early antibiotic treatment
Title
Measurements
No
OG0007
OG00111
OG00213
Yes
0
24
0
24
18
24
EG001
Part A: ACE527 Plus dmLT
Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months.
0
24
0
24
14
24
EG002
Part A: Placebo
Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months.
0
12
0
12
7
12
EG003
Part B: ACE527 Alone
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).
0
13
1
12
8
13
EG004
Part B: ACE527 Plus dmLT
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).
0
13
0
12
9
13
EG005
Part B: Control
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.