Diarrhea
Conditions
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.
Interventions
BIOLOGICALACE527
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.
BIOLOGICALdmLT
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.
BIOLOGICALCeraVacx placebo
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.
BIOLOGICALH10407 challenge strain
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.
Sponsors
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part A of the study was masked to the participant, care provider, investigator, and outcomes assessor. Part B was open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female healthy adults between 18 and 50 years of age at the time of enrollment. 2. General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI. 3. 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. 4. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained. 5. 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). 6. Availability for the study duration, including all planned follow-up visits. 7. 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
1. 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. 2. Significant abnormalities in screening hematology, or serum chemistry as determined by PI or PI in consultation with the Medical Officer and sponsor. 3. Presence in the serum of HIV antibody, HBsAg, or HCV antibody. 4. Evidence of IgA deficiency (serum IgA \< 7 mg/dl or limit of detection of assay). 5. Evidence of current excessive alcohol consumption or drug dependence. 6. Volunteers whose Body Mass Index (BMI) is less than 19.0 or greater than 34.0 (kg/m2) 7. Recent vaccination or receipt of an investigational product (within 30 days before vaccination). 8. 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). 9. 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 10. Working as a food handler, in child-care or as a healthcare worker with direct patient contact. 11. 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). 12. Abnormal stool pattern (fewer than 3 per week or more than 3 per day). 13. Regular (≥ weekly) use of laxatives, antacids, or other agents to lower stomach acidity. 14. 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. 15. 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. 16. Vaccination for or ingestion of ETEC, cholera, or LT toxin within 3 years prior to dosing. 17. Use of antibiotics during the 7 days before dosing or proton pump inhibitors, H2 blockers or antacids within 48hours prior to dosing. 18. 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). 19. Known allergy to two of the three following antibiotics: Ciprofloxacin, amoxicillin, and/or trimethoprim/sulfamethoxazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain | 5 days | 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 |
| 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) | Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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) | Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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) | Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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) | Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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 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 of Serious Adverse Events and Adverse Events Leading to Withdrawal | up to 1 month after last vaccination (3 months) | 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. |
| Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | up to 1 month after last vaccination (3 months) | 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. |
| Part A: Number of Solicited Reactions | up to 1 week after each vaccination (at 0, 1, and 2 months) | Solicited reactions were collected 1 week after each vaccination. |
| Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4 | Defined as a four-fold rise or greater in geometric mean titer. |
| Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1 Day 3 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) | Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4 | Defined as a four-fold rise or greater in geometric mean titer. |
| 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) | Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4 | Defined as a four-fold rise or greater in geometric mean titer. |
| 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) | Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4 | Defined as a four-fold rise or greater in geometric mean titer. |
| 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) | Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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) | Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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) | Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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: Number and Percentage of Subjects With Positive 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 | Defined as a 2.5-fold rise or greater in geometric mean titer. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With Positive Shedding Results for ACE527 | 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 | 5 days | 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 |
| Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer | 5 days | 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 |
| Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer | 5 days | 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 |
| Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer | 5 days | 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 |
| Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer | 5 days | 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 |
| Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | 1 week | 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. |
| Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | 5 days | 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. |
| Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea | 5 days | 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 |
| 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 | — |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A: ACE527 Alone Participants assigned to receiving three oral doses of ACE527 only at 0, 1, and 2 months. | 24 |
| Part A: ACE527 Plus dmLT Participants assigned to receiving three oral doses of ACE527 plus mucosal adjuvant (dmLT) at 0, 1, and 2 months. | 24 |
| Part A: Placebo Participants assigned to receiving three oral doses of CeraVacx placebo at 0, 1, and 2 months. | 12 |
| 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. | 13 |
| 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. | 13 |
| 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. | 31 |
| Total | 117 |
Baseline characteristics
| Characteristic | Part A: ACE527 Alone | Part A: ACE527 Plus dmLT | Part A: Placebo | Total | Part B: ACE527 Alone | Part B: ACE527 Plus dmLT | Part B: Control |
|---|---|---|---|---|---|---|---|
| Age, Continuous Part A | 35.8 years | 37.6 years | 37.0 years | 36.8 years | — | — | — |
| Age, Continuous Part B | — | — | — | 36.9 years | 37.0 years | 37.6 years | 36.5 years |
| Ethnicity (NIH/OMB) Part A Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Part A Not Hispanic or Latino | 22 Participants | 23 Participants | 11 Participants | 56 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Part A Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Part B Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Part B Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 54 Participants | 12 Participants | 12 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Part B Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height Part A | 69.4 inches | 67.4 inches | 69.1 inches | 68.5 inches | — | — | — |
| Height Part B | — | — | — | 68.7 inches | 70.0 inches | 66.7 inches | 69 inches |
| Race (NIH/OMB) Part A American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | — | — | — |
| Race (NIH/OMB) Part A Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Part A Black or African American | 20 Participants | 21 Participants | 12 Participants | 53 Participants | — | — | — |
| Race (NIH/OMB) Part A More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Part A Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Part A Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Part A White | 3 Participants | 3 Participants | 0 Participants | 6 Participants | — | — | — |
| Race (NIH/OMB) Part B American Indian or Alaska Native | — | — | — | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B Asian | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B Black or African American | — | — | — | 49 Participants | 10 Participants | 10 Participants | 29 Participants |
| Race (NIH/OMB) Part B More than one race | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B Native Hawaiian or Other Pacific Islander | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B Unknown or Not Reported | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B White | — | — | — | 7 Participants | 2 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Part A Female | 7 Participants | 9 Participants | 1 Participants | 17 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Part A Male | 17 Participants | 15 Participants | 11 Participants | 43 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Part B Female | 0 Participants | 0 Participants | 0 Participants | 16 Participants | 4 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Part B Male | 0 Participants | 0 Participants | 0 Participants | 41 Participants | 9 Participants | 7 Participants | 25 Participants |
| Weight Part A | 190.3 pounds | 171.7 pounds | 176.2 pounds | 180.0 pounds | — | — | — |
| Weight Part B | — | — | — | 185.7 pounds | 197.8 pounds | 176.5 pounds | 184.5 pounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 31 |
| other Total, other adverse events | 18 / 24 | 14 / 24 | 7 / 12 | 8 / 13 | 9 / 13 | 19 / 31 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 12 | 1 / 12 | 0 / 12 | 0 / 31 |
Outcome results
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)
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 0.93 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1.04 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0.87 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 0.97 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 1.08 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0.97 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 0.96 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1.05 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 1.13 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 4.15 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 1.11 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 4.14 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 1.23 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 1.02 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 3.39 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1.04 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 1.03 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 5.05 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 0.83 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 0.94 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 5.62 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 1.38 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 3.08 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1.05 fold change |
Primary
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 0.87 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 1.13 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.89 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 1.16 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0.97 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1.22 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1.00 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1.14 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 1.87 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 2.68 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 1.66 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 2.08 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1.74 fold change |
| Part A: ACE527 Plus dmLT | 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 | 1.17 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 2.95 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1.14 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 1.21 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 1.67 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 0.96 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 1.38 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1.68 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1.40 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1.50 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0.94 fold change |
Primary
Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 1 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 1 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 1 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 1 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.01 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0.96 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0.96 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 0.97 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0.96 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0.97 fold change |
| Part A: ACE527 Plus dmLT | 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 | 0.95 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.96 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0.96 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 1.00 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 1.00 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 1.00 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 1.03 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1.03 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1.04 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1.00 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.00 fold change |
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)
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0.90 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 0.96 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 0.92 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 1.00 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 0.92 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 0.93 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 0.89 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0.89 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.47 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 2.65 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 1.65 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.99 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.20 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0.95 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 10.95 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0.96 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.06 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 6.45 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0.89 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 1.07 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1.62 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.01 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.58 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0.84 fold change |
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)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0.96 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 1.05 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 1.22 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0.92 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 1.00 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1.09 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1.21 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0.97 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 1.08 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 1.22 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 1.12 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 1.68 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 1.24 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 2.00 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1.56 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 1.25 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1.03 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 1.95 fold change |
Primary
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.96 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0.95 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1.13 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1.19 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1.27 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.20 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.12 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 1.15 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1.26 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1.16 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 1.14 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1.17 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0.95 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1.15 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.05 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1.30 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.99 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1.24 fold change |
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)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0.78 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0.86 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 1.26 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0.85 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 0.91 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 0.95 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 3.22 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1.05 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 2.05 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 2.38 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 1.42 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 2.51 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 2.04 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 3.82 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 5.07 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 3.61 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1.38 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 4.69 fold change |
Primary
Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1.38 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.80 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0.76 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1.57 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1.45 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.38 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 1.10 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1.49 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.57 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1.65 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1.58 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.96 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 1.00 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 1.01 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1.58 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 1.61 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1.77 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 2.20 fold change |
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0.94 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.97 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1.13 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1.10 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1.15 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1.11 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1.06 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 1.02 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0.99 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1.00 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 1.08 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1.23 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 1.06 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1.17 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1.12 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1.04 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 1.00 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1.09 fold change |
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 0.99 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.00 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.00 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.09 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1.09 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1.05 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1.23 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 2.49 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.60 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1.60 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.44 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.44 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.62 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.62 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1.36 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.49 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 2.42 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1.49 fold change |
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0.97 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0.96 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1.19 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1.01 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.99 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1.04 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0.94 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0.94 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0.95 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.96 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1.14 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0.97 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0.89 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0.84 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.90 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0.84 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0.88 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1.00 fold change |
Primary
Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 1.06 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.15 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.13 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.33 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1.30 fold change |
| Part A: ACE527 Alone | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1.15 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1.16 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 1.17 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.41 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1.19 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.15 fold change |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.37 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1.31 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1.68 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1.21 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1.59 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 1.22 fold change |
| Part A: Placebo | Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1.62 fold change |
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)
Time frame: Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0.284 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 0.343 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 0.353 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 0.316 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 0.326 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 0.314 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0.339 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 0.303 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0.316 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 0.457 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 0.387 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 0.395 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1.310 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0.436 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 1.603 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0.465 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 1.573 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 0.413 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1.606 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 0.318 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0.437 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 0.264 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 0.332 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 0.306 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0.334 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 1.775 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 0.998 titer |
Primary
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Time frame: Pre all vaccinations; day 3 post-vaccination 1 and 2; day 7 post all vaccinations; 4 weeks post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 0.292 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0.283 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0.331 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 0.256 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0.357 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 0.338 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0.333 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0.292 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.262 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 0.360 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0.509 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0.784 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0.358 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 0.306 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0.904 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.572 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 0.531 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0.638 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0.288 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0.431 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0.389 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0.515 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0.466 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 0.310 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 0.322 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 0.418 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0.539 titer |
Primary
Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Time frame: Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0.14 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0.141 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0.14 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 0.14 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 0.14 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0.14 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.14 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 0.14 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0.14 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 0.142 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 0.148 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 0.140 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.142 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0.143 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0.143 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0.145 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0.143 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0.142 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0.140 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 0.141 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0.146 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 0.140 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0.14 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 0.145 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0.14 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0.145 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0.14 titer |
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)
Time frame: Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 0.162 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0.164 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 0.161 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 0.175 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 0.175 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 0.164 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 0.168 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0.157 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 0.171 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 0.307 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 0.183 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0.175 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 2.008 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 0.269 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 0.365 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 0.208 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 0.460 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0.173 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 1.146 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 0.178 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 0.186 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0.158 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0.155 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 0.179 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 0.186 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 0.299 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 0.274 titer |
Primary
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 255 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 245 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 323 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 266 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 289 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 265 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 278 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 646 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 385 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 375 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 432 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 403 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 458 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 449 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 350 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 306 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 436 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 545 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 582 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 365 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 298 titer |
Primary
Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1914 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 2087 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 3099 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 2469 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 2350 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 2246 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 2112 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 4996 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 1990 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 2098 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 2822 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 4205 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 4877 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 6267 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 6030 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 2635 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 8458 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 7839 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 6429 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 3616 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Pre-Vaccination 1 | 1903 titer |
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 289 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 340 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 350 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 309 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 344 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 355 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 299 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 420 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 341 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 347 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 368 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 347 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 350 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 377 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 324 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 325 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 348 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 337 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 386 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 350 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 324 titer |
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 15.3 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 20.2 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 17.9 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 15.1 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 15.9 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 19.0 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 18.9 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 23.0 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 22.2 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 20.0 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 23.0 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 22.8 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 23.4 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 21.2 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 18.1 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 17.1 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 16.3 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 19.0 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 15.3 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 14.9 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 16.2 titer |
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 96.1 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 106 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 97.0 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 96.9 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 102 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 106 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 97.1 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 189 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 101 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 251 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 145 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 142 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 163 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 120 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 172 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 264 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 143 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 157 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 212 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 171 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 109 titer |
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1627 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1673 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1563 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 1597 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 1610 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1915 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 1544 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 1265 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1317 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 1188 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1439 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 1208 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1236 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1278 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1754 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1733 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Pre-Vaccination 1 | 1809 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 1522 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 1712 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1939 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1648 titer |
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 56.8 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 52.5 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 49.9 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 27.4 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 36.2 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 50.0 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 29.0 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 68.2 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 115 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 65.2 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 112 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 75.1 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 113 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 122 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 86.6 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 95.2 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Pre-Vaccination 1 | 54.3 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 54.1 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 52.9 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 85.7 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 118 titer |
Primary
Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)
Time frame: Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 727 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 729 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 842 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 713 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 668 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 633 titer |
| Part A: ACE527 Alone | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 823 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 885 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 748 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 874 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 858 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1022 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1159 titer |
| Part A: ACE527 Plus dmLT | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 979 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Pre-Vaccination 1 | 646 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1079 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 785 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 820 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1103 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1116 titer |
| Part A: Placebo | Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 856 titer |
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.
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 11 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 12 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 7 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 12 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 13 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 10 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1 Participants |
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.
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 7 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 3 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 8 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 3 | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 3 | 1 Participants |
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.
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0 Participants |
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.
Time frame: Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 4 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 7 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 3 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 5 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 18 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 12 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 4 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 8 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 5 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 1 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 1 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 6 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 3 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 11 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 9 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 4 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 6 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 4 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 4 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 14 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 8 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 10 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 3 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 12 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Pre-vaccination | 8 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 2: Day 7 | 14 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Week 4 | 17 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Pre-vaccination | 14 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 1: Day 7 | 5 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB) | Vaccination 3: Day 7 | 15 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 3: Week 4 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3) | Vaccination 1: Day 7 | 0 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 3 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 1 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 2 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 2 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 9 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 6 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 6 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 7 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Day 7 | 5 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Pre-vaccination | 10 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 1: Day 7 | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 3: Week 4 | 5 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Day 7 | 5 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6) | Vaccination 2: Pre-vaccination | 3 Participants |
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.
Time frame: Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 1 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1 Participants |
| Part A: ACE527 Alone | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Pre-vaccination | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 2: Day 7 | 4 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Week 4 | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Pre-vaccination | 3 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 1: Day 7 | 2 Participants |
| Part A: Placebo | Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I) | Vaccination 3: Day 7 | 4 Participants |
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.
Time frame: up to 1 month after last vaccination (3 months)
Population: Participants in Part A of the study who received at least one dose of the study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Mild | 10 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Moderate | 8 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Severe | 0 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Mild | 2 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Moderate | 0 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Severe | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Severe | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Mild | 9 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Mild | 6 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Moderate | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Moderate | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Severe | 1 Participants |
| Part A: Placebo | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Moderate | 3 Participants |
| Part A: Placebo | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Severe | 0 Participants |
| Part A: Placebo | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Severe | 0 Participants |
| Part A: Placebo | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Mild | 0 Participants |
| Part A: Placebo | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Not related: Mild | 4 Participants |
| Part A: Placebo | Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination | Related: Moderate | 1 Participants |
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.
Time frame: up to 1 month after last vaccination (3 months)
Population: Participants in Part A of the study who received at least one dose of the study product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal | Serious adverse event | 0 adverse events |
| Part A: ACE527 Alone | Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal | Adverse event leading to withdrawal | 0 adverse events |
| Part A: ACE527 Plus dmLT | Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal | Serious adverse event | 0 adverse events |
| Part A: ACE527 Plus dmLT | Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal | Adverse event leading to withdrawal | 1 adverse events |
| Part A: Placebo | Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal | Serious adverse event | 0 adverse events |
| Part A: Placebo | Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal | Adverse event leading to withdrawal | 0 adverse events |
Primary
Part A: Number of Solicited Reactions
Solicited reactions were collected 1 week after each vaccination.
Time frame: up to 1 week after each vaccination (at 0, 1, and 2 months)
Population: Participants in Part A of the study who received at least one dose of the study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Borborygmus (gurgling) | 6 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Fever | 1 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Loose stools | 5 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Urgency of Defecation | 4 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Nausea | 4 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Diarrhea | 1 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Abdominal Pain | 3 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Vomiting | 2 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Chills | 0 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Malaise | 1 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Any reaction | 12 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Anorexia | 3 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Headache | 5 Participants |
| Part A: ACE527 Alone | Part A: Number of Solicited Reactions | Temperature | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Borborygmus (gurgling) | 6 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Anorexia | 4 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Chills | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Diarrhea | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Loose stools | 11 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Headache | 7 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Fever | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Nausea | 3 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Vomiting | 1 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Abdominal Pain | 7 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Urgency of Defecation | 6 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Malaise | 2 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Temperature | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Solicited Reactions | Any reaction | 15 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Temperature | 0 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Urgency of Defecation | 1 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Headache | 1 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Loose stools | 2 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Borborygmus (gurgling) | 2 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Diarrhea | 0 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Anorexia | 1 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Malaise | 1 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Chills | 1 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Vomiting | 1 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Nausea | 0 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Any reaction | 4 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Abdominal Pain | 2 Participants |
| Part A: Placebo | Part A: Number of Solicited Reactions | Fever | 0 Participants |
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
Time frame: 5 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain | Not severe | 6 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain | Severe | 7 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain | Not severe | 10 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain | Severe | 3 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain | Not severe | 10 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain | Severe | 21 Participants |
Secondary
Number of Participants Shedding Vaccine Strains Included in ACE527
Time frame: 3 days after the first and second vaccinations
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2027 strain: Vaccination 1 | 17 Participants |
| Part A: ACE527 Alone | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2025 strain: Vaccination 1 | 6 Participants |
| Part A: ACE527 Alone | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2027 strain: Vaccination 2 | 12 Participants |
| Part A: ACE527 Alone | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2022 strain: Vaccination 1 | 9 Participants |
| Part A: ACE527 Alone | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2025 strain: Vaccination 2 | 5 Participants |
| Part A: ACE527 Alone | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2022 strain: Vaccination 2 | 4 Participants |
| Part A: ACE527 Plus dmLT | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2025 strain: Vaccination 2 | 7 Participants |
| Part A: ACE527 Plus dmLT | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2027 strain: Vaccination 1 | 13 Participants |
| Part A: ACE527 Plus dmLT | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2027 strain: Vaccination 2 | 11 Participants |
| Part A: ACE527 Plus dmLT | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2022 strain: Vaccination 2 | 7 Participants |
| Part A: ACE527 Plus dmLT | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2022 strain: Vaccination 1 | 11 Participants |
| Part A: ACE527 Plus dmLT | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2025 strain: Vaccination 1 | 5 Participants |
| Part A: Placebo | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2027 strain: Vaccination 2 | 0 Participants |
| Part A: Placebo | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2022 strain: Vaccination 1 | 0 Participants |
| Part A: Placebo | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2022 strain: Vaccination 2 | 0 Participants |
| Part A: Placebo | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2025 strain: Vaccination 1 | 0 Participants |
| Part A: Placebo | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2025 strain: Vaccination 2 | 0 Participants |
| Part A: Placebo | Number of Participants Shedding Vaccine Strains Included in ACE527 | ACAM2027 strain: Vaccination 1 | 0 Participants |
Secondary
Part A: Number of Participants Shedding E. Coli on Qualification Plate
Time frame: Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 0 | 22 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 28 | 20 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 7 | 21 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 3 | 21 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 0 | 21 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 7 | 18 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 7 | 24 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 3 | 24 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 0 | 17 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 3 | 20 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 0 | 23 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 3 | 23 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 7 | 23 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 0 | 21 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 7 | 21 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 0 | 20 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 7 | 21 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 28 | 20 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 7 | 10 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 0 | 10 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 0 | 10 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 1: Day 3 | 10 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 28 | 11 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 3 | 9 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 0 | 11 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 3: Day 7 | 10 Participants |
| Part A: Placebo | Part A: Number of Participants Shedding E. Coli on Qualification Plate | Vaccination 2: Day 7 | 9 Participants |
Secondary
Part A: Number of Participants With Positive Shedding Results for ACE527
Time frame: Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3
Population: Subjects who received the vaccination and had valid test results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 0 | 1 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 28 | 1 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 7 | 5 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 3 | 14 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 0 | 0 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 7 | 3 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 7 | 11 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 3 | 22 Participants |
| Part A: ACE527 Alone | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 0 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 3 | 12 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 0 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 3 | 16 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 7 | 3 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 0 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 7 | 3 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 0 | 0 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 7 | 4 Participants |
| Part A: ACE527 Plus dmLT | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 28 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 7 | 1 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 0 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 0 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 1: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 28 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 3 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 0 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 3: Day 7 | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Positive Shedding Results for ACE527 | Vaccination 2: Day 7 | 0 Participants |
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
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: ACE527 Alone | Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer | 11.7 stools | Standard Deviation 9.61 |
| Part A: ACE527 Plus dmLT | Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer | 6.0 stools | Standard Deviation 9.68 |
| Part A: Placebo | Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer | 10.8 stools | Standard Deviation 7.99 |
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
Time frame: 5 days
Population: Among subjects who met the protocol definition of diarrhea over the observation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: ACE527 Alone | Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea | 51.5 hours | Standard Deviation 26.88 |
| Part A: ACE527 Plus dmLT | Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea | 59.9 hours | Standard Deviation 27.12 |
| Part A: Placebo | Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea | 46.4 hours | Standard Deviation 20.35 |
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
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: ACE527 Alone | Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer | 1655.1 grams | Standard Deviation 1743.1 |
| Part A: ACE527 Plus dmLT | Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer | 748.8 grams | Standard Deviation 1574.6 |
| Part A: Placebo | Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer | 1878.2 grams | Standard Deviation 1729.4 |
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
Time frame: 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: ACE527 Alone | Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer | 14 stools |
| Part A: ACE527 Plus dmLT | Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer | 1 stools |
| Part A: Placebo | Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer | 12 stools |
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
Time frame: 5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part A: ACE527 Alone | Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer | 859 grams |
| Part A: ACE527 Plus dmLT | Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer | 30 grams |
| Part A: Placebo | Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer | 1400 grams |
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
Time frame: 5 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Severe | 7 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Mild | 2 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | None | 3 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Moderate | 1 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | None | 9 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Severe | 3 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Moderate | 1 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Mild | 0 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Severe | 21 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Mild | 2 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | Moderate | 0 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity | None | 8 Participants |
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.
Time frame: 5 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Changed planned activities | No | 9 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Changed planned activities | Yes | 4 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Stayed in bed | No | 9 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Stayed in bed | Yes | 4 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Either of the above | No | 7 Participants |
| Part A: ACE527 Alone | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Either of the above | Yes | 6 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Either of the above | Yes | 5 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Changed planned activities | No | 8 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Stayed in bed | Yes | 3 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Either of the above | No | 8 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Changed planned activities | Yes | 5 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Stayed in bed | No | 10 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Changed planned activities | Yes | 21 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Stayed in bed | No | 14 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Either of the above | Yes | 21 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Stayed in bed | Yes | 17 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Changed planned activities | No | 10 Participants |
| Part A: Placebo | Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity | Either of the above | No | 10 Participants |
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.
Time frame: 1 week
Population: Participants in Part A of the study who received at least one dose of the study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Malaise | 3 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Nausea | 3 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Vomiting | 1 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Abdominal Pain | 0 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Urgency of Defecation | 1 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Borborygmus (gurgling) | 2 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Headache | 2 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Anorexia | 4 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Myalgia | 0 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Chills | 2 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Temperature | 2 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Any reaction | 8 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Any reaction | 8 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Myalgia | 1 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Nausea | 2 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Headache | 2 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Malaise | 3 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Vomiting | 0 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Temperature | 1 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Anorexia | 2 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Abdominal Pain | 4 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Borborygmus (gurgling) | 3 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Chills | 2 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Urgency of Defecation | 2 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Temperature | 3 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Chills | 8 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Borborygmus (gurgling) | 15 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Malaise | 11 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Headache | 5 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Anorexia | 14 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Urgency of Defecation | 13 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Nausea | 9 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Myalgia | 6 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Vomiting | 2 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Any reaction | 18 Participants |
| Part A: Placebo | Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe | Abdominal Pain | 13 Participants |
Secondary
Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids
Time frame: 5 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: ACE527 Alone | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | Early antibiotic treatment | No | 7 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | IV fluids | Yes | 4 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | IV fluids | No | 9 Participants |
| Part A: ACE527 Alone | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | Early antibiotic treatment | Yes | 6 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | Early antibiotic treatment | Yes | 2 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | IV fluids | No | 9 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | IV fluids | Yes | 4 Participants |
| Part A: ACE527 Plus dmLT | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | Early antibiotic treatment | No | 11 Participants |
| Part A: Placebo | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | IV fluids | Yes | 15 Participants |
| Part A: Placebo | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | Early antibiotic treatment | No | 13 Participants |
| Part A: Placebo | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | IV fluids | No | 16 Participants |
| Part A: Placebo | Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids | Early antibiotic treatment | Yes | 18 Participants |
Secondary
Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge
Time frame: 2 days after vaccination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: ACE527 Alone | Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge | 261.30 colony forming units | Standard Deviation 391.5 |
| Part A: ACE527 Plus dmLT | Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge | 94.345 colony forming units | Standard Deviation 199.1 |
| Part A: Placebo | Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge | 154.84 colony forming units | Standard Deviation 321.4 |