Healthy
Conditions
Keywords
shigella
Brief summary
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates. An adaptable dosing plan was used to determine the dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.
Detailed description
Primary objectives: 1. Establish a human challenge model of S. sonnei 53G infection using a lyophilized formulation of the challenge strain. 2. Identify a dose of lyophilized S. sonnei 53G that induces the primary outcome in approximately 60% of subjects with no adverse safety concerns. Secondary objectives: 1. Estimate quantitative shedding and basic immunogenicity of the challenge strain. 2. Collect and archive blood and fecal samples for systems biology, microbiome, and other omics-based work to be conducted under a separate research protocol in future studies.
Interventions
BIOLOGICALShigella sonnei 53G
Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast. Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)
Sponsors
United States Department of Defense
Children's Hospital Medical Center, Cincinnati
PATH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or non-pregnant female between 18 and 49 years of age (inclusive). 2. General good health defined as (a) no significant medical illness, (b) no clinically significant physical examination findings and (c) no screening laboratory values significantly outside the normal limits of the testing laboratory within 45 days of challenge. 3. Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (pass grade ≥70%) on day -1. 4. Willing to sign an informed consent form (ICF). 5. Willingness to participate for an inpatient stay lasting up to 11 days and an outpatient follow-up lasting 6 months from challenge. 6. Willing to not smoke during the inpatient stay. 7. Available for all planned follow-up visits. 8. Negative serum pregnancy test at screening and negative urine pregnancy test on the day of admission to the inpatient phase for female subjects of childbearing potential. Females of childbearing potential must agree to use an effective method of birth control (birth control pills, injection hormonal contraceptive, implant hormonal contraceptive, hormonal patch, intrauterine device (IUD), sterilization by hysterectomy or tubal ligation, spermicidal products and barrier methods such as cervical sponge, diaphragm, or condom) within two months of challenge and during the entire study. Abstinence is acceptable. A woman is eligible if she is monogamous with a vasectomized partner. 9. Willing to not donate blood for up to 6 months after completion of the inpatient phase of the study. 10. Willing to refrain from participation in another investigational vaccine or drug trial at least until after completion of the 6 month follow-up safety call.
Exclusion criteria
1. Presence of a significant medical condition (e.g. psychiatric conditions, alcohol or illicit drug abuse/dependency, or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study. 2. Immunosuppressive illness or immunoglobulin A (IgA) deficiency 3. Positive serology results for HIV, HBsAg, hepatitis C virus (HCV), or syphilis (RPR) antibodies. 4. Evidence of inflammatory arthritis on exam and/or human leukocyte antigen B27 (HLA-B27) positive. 5. Family history of inflammatory arthritis. 6. Significant abnormalities in screening lab hematology or serum chemistry, as determined by PI. 7. Allergy to fluoroquinolones or trimethoprim-sulfamethoxazole 8. Fewer than 3 stools per week or more than 3 stools per day as the usual frequency. 9. History of diarrhea in the 2 weeks prior to planned inpatient phase 10. Use of antibiotics during the 7 days before receiving the challenge inoculum dosing 11. Use of prescription and/or over the counter (OTC) medications that contain Imodium, acetaminophen, aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs, during the 48 hours prior to investigational product administration 12. Travel within two years prior to dosing to countries where Shigella infection is endemic. 13. Use of any medication known to affect the immune function \[e.g., oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 μg/day of beclomethasone dipropionate or equivalent and others): nasal and topical steroids are allowed\] within 30 days preceding receipt of the challenge inoculum or planned use during the active study period. 14. Serologic evidence of Shigella sonnei (titer \> 1:2500) 15. A positive urine test for opiates. 16. A chronic disease (such as hypertension, hyperlipidemia or anxiety/depression) for which doses of prescription medications are not stable for at least the past 3 months. 17. Scheduled and/or long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 μg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal, intra-articular, and topical steroids are allowed) 18. Have immunocompromised household contacts. 19. A clinically significant abnormality on physical examination, including a systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg, or a resting pulse \>100 beats/min or \<55 beats/min (\<50 beats/min for conditioned athletes). 20. Pregnant, nursing, or plan to become pregnant within 6 months of receipt of the study product. 21. In the 4 weeks following challenge, subject will be living with or having daily contact with elderly persons aged 70 years or more, diapered individuals, persons with disabilities, children \<2 years old, or a woman known to be pregnant or nursing, or anyone with diminished immunity. This includes contact at home, school, day-care, nursing homes, or similar places. 22. Work in a health care setting, day care center, or as a food handler in the 4 weeks following the challenge with S. sonnei. 23. Use of any investigational drug or any investigational vaccine within 60 days preceding challenge, or planned use during the 6 months after receipt of the study agent. 24. Have received a licensed, live vaccine within 28 days or a licensed inactivated vaccine within 14 days of receiving the challenge inoculum. 25. Inability to comply with inpatient rules and regulations. 26. Has any other condition that, in the opinion of the Investigator, would jeopardize the safety or rights of a participant or would render the subject unable to comply with the protocol. 27. Received blood or blood products within the past six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Shigellosis | 11 days after administration of S. sonnei | Per protocol definition: shedding of S. sonnei in the stool accompanied by moderate-severe diarrhea (4 or more loose/watery Grade 3-5 stools or 400+ gram stools per 24 hours, or requires medical intervention) and/or dysentery (a Grade 3, 4, or 5 stool with gross blood on at least 2 occasions and reportable constitutional symptoms) along with moderate fever (Oral temperature of ≥101.2°F) or one or more severe intestinal symptoms. Alternative endpoint 1 definition: severe diarrhea, or moderate diarrhea plus fever, or moderate diarrhea plus 1 moderate constitutional/enteric symptom, or dysentery. Alternative endpoint 2 definition: severe diarrhea, or moderate diarrhea plus fever, or moderate diarrhea plus 1 severe constitutional/enteric symptom, or dysentery plus 1 severe constitutional/enteric symptom |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline (days -5,-1), Day 3, Day 7, and Day 14 | IgA (total and S. sonnei specific) will be determined in fecal extracts using standard ELISA. IgA was recovered from stool samples using a soybean trypsin inhibitor-EDTA procedure. The shigella-antigen specific activity was calculated by dividing the endpoint titer by the IgA concentration in matched samples. |
| Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | 57 days | Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA). |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline (days -5,-1), Day 3, Day 7, and Day 14 | IgA (total and S. sonnei specific) will be determined in fecal extracts using standard ELISA. IgA was recovered from stool samples using a soybean trypsin inhibitor ethylenediaminetetraacetic acid (EDTA) procedure. The shigella-antigen specific activity was calculated by dividing the endpoint titer by the IgA concentration in matched samples. |
| Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | 57 days | Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA). |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | 57 days | Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA). |
| Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | 57 days | Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the recruiting range of Cincinnati Children's Hospital Medical Center (CCHMC) via word of mouth and advertisements in multiple formats including but not limited to newspapers, fliers, e-mails, and the CCHMC website.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Received 500 colony-forming units (CFU) of Shigella sonnei 53G.
Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts) | 10 |
| Cohort 2 Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 1 experienced shigellosis, or lower dose if not.
Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts) | 10 |
| Cohort 3 Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 2 experienced shigellosis, or lower dose if not.
Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts) | 10 |
| Cohort 4 Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 3 experienced shigellosis, or lower dose if not.
Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts) | 10 |
| Cohort 5 Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 4 experienced shigellosis, or lower dose if not.
Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts) | 16 |
| Total | 56 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 10.7 | 32.3 years STANDARD_DEVIATION 9.9 | 34.3 years STANDARD_DEVIATION 9.9 | 32.2 years STANDARD_DEVIATION 8.8 | 30.1 years STANDARD_DEVIATION 8.8 | 32.6 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 10 Participants | 10 Participants | 10 Participants | 16 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 9 Participants | 10 Participants | 10 Participants | 14 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 6 Participants | 7 Participants | 10 Participants | 33 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants | 3 Participants | 6 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 16 |
| other Total, other adverse events | 6 / 10 | 10 / 10 | 10 / 10 | 10 / 10 | 15 / 16 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 16 |
Outcome results
Primary
Number of Participants With Shigellosis
Per protocol definition: shedding of S. sonnei in the stool accompanied by moderate-severe diarrhea (4 or more loose/watery Grade 3-5 stools or 400+ gram stools per 24 hours, or requires medical intervention) and/or dysentery (a Grade 3, 4, or 5 stool with gross blood on at least 2 occasions and reportable constitutional symptoms) along with moderate fever (Oral temperature of ≥101.2°F) or one or more severe intestinal symptoms. Alternative endpoint 1 definition: severe diarrhea, or moderate diarrhea plus fever, or moderate diarrhea plus 1 moderate constitutional/enteric symptom, or dysentery. Alternative endpoint 2 definition: severe diarrhea, or moderate diarrhea plus fever, or moderate diarrhea plus 1 severe constitutional/enteric symptom, or dysentery plus 1 severe constitutional/enteric symptom
Time frame: 11 days after administration of S. sonnei
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 | Number of Participants With Shigellosis | Per protocol definition | No | 10 Participants |
| Cohort 1 | Number of Participants With Shigellosis | Alternative endpoint 2 | No | 10 Participants |
| Cohort 1 | Number of Participants With Shigellosis | Alternative endpoint 1 | No | 10 Participants |
| Cohort 1 | Number of Participants With Shigellosis | Alternative endpoint 2 | Yes | 0 Participants |
| Cohort 1 | Number of Participants With Shigellosis | Per protocol definition | Yes | 0 Participants |
| Cohort 1 | Number of Participants With Shigellosis | Alternative endpoint 1 | Yes | 0 Participants |
| Cohort 2 | Number of Participants With Shigellosis | Alternative endpoint 1 | No | 4 Participants |
| Cohort 2 | Number of Participants With Shigellosis | Alternative endpoint 2 | Yes | 5 Participants |
| Cohort 2 | Number of Participants With Shigellosis | Per protocol definition | No | 8 Participants |
| Cohort 2 | Number of Participants With Shigellosis | Alternative endpoint 1 | Yes | 6 Participants |
| Cohort 2 | Number of Participants With Shigellosis | Alternative endpoint 2 | No | 5 Participants |
| Cohort 2 | Number of Participants With Shigellosis | Per protocol definition | Yes | 2 Participants |
| Cohort 3 | Number of Participants With Shigellosis | Per protocol definition | Yes | 1 Participants |
| Cohort 3 | Number of Participants With Shigellosis | Alternative endpoint 2 | No | 7 Participants |
| Cohort 3 | Number of Participants With Shigellosis | Per protocol definition | No | 9 Participants |
| Cohort 3 | Number of Participants With Shigellosis | Alternative endpoint 1 | Yes | 4 Participants |
| Cohort 3 | Number of Participants With Shigellosis | Alternative endpoint 1 | No | 6 Participants |
| Cohort 3 | Number of Participants With Shigellosis | Alternative endpoint 2 | Yes | 3 Participants |
| Cohort 4 | Number of Participants With Shigellosis | Alternative endpoint 2 | Yes | 6 Participants |
| Cohort 4 | Number of Participants With Shigellosis | Alternative endpoint 1 | No | 3 Participants |
| Cohort 4 | Number of Participants With Shigellosis | Per protocol definition | Yes | 4 Participants |
| Cohort 4 | Number of Participants With Shigellosis | Alternative endpoint 2 | No | 4 Participants |
| Cohort 4 | Number of Participants With Shigellosis | Alternative endpoint 1 | Yes | 7 Participants |
| Cohort 4 | Number of Participants With Shigellosis | Per protocol definition | No | 6 Participants |
| Cohort 5 | Number of Participants With Shigellosis | Alternative endpoint 2 | No | 9 Participants |
| Cohort 5 | Number of Participants With Shigellosis | Per protocol definition | No | 14 Participants |
| Cohort 5 | Number of Participants With Shigellosis | Alternative endpoint 1 | Yes | 7 Participants |
| Cohort 5 | Number of Participants With Shigellosis | Alternative endpoint 1 | No | 9 Participants |
| Cohort 5 | Number of Participants With Shigellosis | Alternative endpoint 2 | Yes | 7 Participants |
| Cohort 5 | Number of Participants With Shigellosis | Per protocol definition | Yes | 2 Participants |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen
Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).
Time frame: 57 days
Population: No sample was available for one subject in Cohort 3 on Day 56.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 28 | 1970 titer | Standard Deviation 4825 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 348 titer | Standard Deviation 596 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 56 | 985 titer | Standard Deviation 1046 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 7 | 429 titer | Standard Deviation 451 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 14 | 3200 titer | Standard Deviation 16194 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 28 | 1213 titer | Standard Deviation 4011 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 14 | 2263 titer | Standard Deviation 7995 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 7 | 1056 titer | Standard Deviation 4076 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 56 | 650 titer | Standard Deviation 1180 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 283 titer | Standard Deviation 330 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 14 | 5198 titer | Standard Deviation 7205 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 115 titer | Standard Deviation 113 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 7 | 528 titer | Standard Deviation 420 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 28 | 1715 titer | Standard Deviation 3660 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 56 | 864 titer | Standard Deviation 2032 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 56 | 1213 titer | Standard Deviation 5145 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 28 | 2425 titer | Standard Deviation 7953 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 400 titer | Standard Deviation 3957 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 14 | 7879 titer | Standard Deviation 19368 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 7 | 1600 titer | Standard Deviation 8146 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 14 | 5620 titer | Standard Deviation 13385 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 56 | 872 titer | Standard Deviation 2105 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 28 | 1822 titer | Standard Deviation 4613 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 183 titer | Standard Deviation 1694 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen | Day 7 | 1131 titer | Standard Deviation 3217 |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).
Time frame: 57 days
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 4222 titer | Standard Deviation 16541 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 373 titer | Standard Deviation 666 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 919 titer | Standard Deviation 877 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 528 titer | Standard Deviation 611 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 2425 titer | Standard Deviation 15598 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 2425 titer | Standard Deviation 10086 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 528 titer | Standard Deviation 1212 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 264 titer | Standard Deviation 610 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 1213 titer | Standard Deviation 10390 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 857 titer | Standard Deviation 5990 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 919 titer | Standard Deviation 2444 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 3200 titer | Standard Deviation 9864 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 264 titer | Standard Deviation 344 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 635 titer | Standard Deviation 1219 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 123 titer | Standard Deviation 138 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 919 titer | Standard Deviation 2474 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 348 titer | Standard Deviation 2073 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 2111 titer | Standard Deviation 7898 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 800 titer | Standard Deviation 2532 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 919 titer | Standard Deviation 4032 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 591 titer | Standard Deviation 1784 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 1037 titer | Standard Deviation 3047 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 3644 titer | Standard Deviation 10457 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 248 titer | Standard Deviation 823 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 1288 titer | Standard Deviation 4164 |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen
IgA (total and S. sonnei specific) will be determined in fecal extracts using standard ELISA. IgA was recovered from stool samples using a soybean trypsin inhibitor-EDTA procedure. The shigella-antigen specific activity was calculated by dividing the endpoint titer by the IgA concentration in matched samples.
Time frame: Baseline (days -5,-1), Day 3, Day 7, and Day 14
Population: Stool samples were not collected from all subjects at all time points. Samples containing less than 2 ug/mL of total IgA were excluded from analysis. If both baseline samples were below 2 ug/mL, the subject was excluded from analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 14 | 422 titer | Standard Deviation 3317 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 3 | 19 titer | Standard Deviation 130 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 2 (Day -1) | 19 titer | Standard Deviation 130 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 53 titer | Standard Deviation 140 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 1 (Day -5) | 20 titer | Standard Deviation 211 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 14 | 118 titer | Standard Deviation 1679 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 3 | 15 titer | Standard Deviation 98 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 1 (Day -5) | 18 titer | Standard Deviation 60 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 2 (Day -1) | 12 titer | Standard Deviation 111 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 92 titer | Standard Deviation 381 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 3 | 6 titer | Standard Deviation 2 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 50 titer | Standard Deviation 124 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 2 (Day -1) | 9 titer | Standard Deviation 105 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 1 (Day -5) | 10 titer | Standard Deviation 104 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 14 | 320 titer | Standard Deviation 459 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 80 titer | Standard Deviation 441 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 2 (Day -1) | 10 titer | Standard Deviation 403 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 1 (Day -5) | 20 titer | Standard Deviation 638 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 14 | 403 titer | Standard Deviation 540 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 3 | 16 titer | Standard Deviation 400 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 14 | 104 titer | Standard Deviation 478 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 2 (Day -1) | 9 titer | Standard Deviation 11 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 3 | 80 titer | Standard Deviation 441 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Day 7 | 84 titer | Standard Deviation 498 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen | Baseline 1 (Day -5) | 11 titer | Standard Deviation 22 |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen
IgA (total and S. sonnei specific) will be determined in fecal extracts using standard ELISA. IgA was recovered from stool samples using a soybean trypsin inhibitor ethylenediaminetetraacetic acid (EDTA) procedure. The shigella-antigen specific activity was calculated by dividing the endpoint titer by the IgA concentration in matched samples.
Time frame: Baseline (days -5,-1), Day 3, Day 7, and Day 14
Population: Stool samples were not collected from all subjects at all time points. Samples containing less than 2 ug/mL of total IgA were excluded from analysis. If both baseline samples were below 2 ug/mL, the subject was excluded from analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 2 (Day -1) | 15 titer | Standard Deviation 53 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 1 (Day -5) | 19 titer | Standard Deviation 130 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 49 titer | Standard Deviation 121 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 3 | 15 titer | Standard Deviation 65 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 14 | 211 titer | Standard Deviation 1024 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 1 (Day -5) | 11 titer | Standard Deviation 8 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 14 | 40 titer | Standard Deviation 841 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 2 (Day -1) | 8 titer | Standard Deviation 26 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 3 | 11 titer | Standard Deviation 14 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 70 titer | Standard Deviation 413 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 80 titer | Standard Deviation 136 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 1 (Day -5) | 11 titer | Standard Deviation 24 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 2 (Day -1) | 11 titer | Standard Deviation 51 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 3 | 9 titer | Standard Deviation 11 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 14 | 226 titer | Standard Deviation 371 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 3 | 11 titer | Standard Deviation 99 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 49 titer | Standard Deviation 296 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 14 | 101 titer | Standard Deviation 205 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 2 (Day -1) | 9 titer | Standard Deviation 200 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 1 (Day -5) | 17 titer | Standard Deviation 157 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 3 | 11 titer | Standard Deviation 21 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 7 | 42 titer | Standard Deviation 155 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 2 (Day -1) | 10 titer | Standard Deviation 15 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Baseline 1 (Day -5) | 8 titer | Standard Deviation 6 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen | Day 14 | 57 titer | Standard Deviation 431 |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen
Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).
Time frame: 57 days
Population: No sample was available for one subject in Cohort 3 on Day 56.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 28 | 9701 titer | Standard Deviation 18863 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 2599 titer | Standard Deviation 5412 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 56 | 6400 titer | Standard Deviation 9199 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 3430 titer | Standard Deviation 7619 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 14 | 10397 titer | Standard Deviation 31301 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 28 | 6859 titer | Standard Deviation 14595 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 14 | 7352 titer | Standard Deviation 30508 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 3940 titer | Standard Deviation 4221 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 56 | 4525 titer | Standard Deviation 7013 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 2599 titer | Standard Deviation 1960 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 14 | 14703 titer | Standard Deviation 14347 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 2986 titer | Standard Deviation 15270 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 3200 titer | Standard Deviation 7303 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 28 | 11943 titer | Standard Deviation 14904 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 56 | 10159 titer | Standard Deviation 9659 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 56 | 5971 titer | Standard Deviation 4758 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 2263 titer | Standard Deviation 4011 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 28 | 9701 titer | Standard Deviation 9361 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 14 | 11143 titer | Standard Deviation 18203 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 3940 titer | Standard Deviation 3477 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 14 | 8300 titer | Standard Deviation 28740 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 28 | 6683 titer | Standard Deviation 33105 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Baseline (Day -1) | 1745 titer | Standard Deviation 12365 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 56 | 4525 titer | Standard Deviation 16370 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen | Day 7 | 3490 titer | Standard Deviation 24798 |
Secondary
Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen
Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).
Time frame: 57 days
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 2425 titer | Standard Deviation 15506 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 528 titer | Standard Deviation 611 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 1393 titer | Standard Deviation 3897 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 746 titer | Standard Deviation 913 |
| Cohort 1 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 4222 titer | Standard Deviation 19953 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 1715 titer | Standard Deviation 8165 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 2425 titer | Standard Deviation 7591 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 919 titer | Standard Deviation 3813 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 1131 titer | Standard Deviation 8350 |
| Cohort 2 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 492 titer | Standard Deviation 547 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 6859 titer | Standard Deviation 15472 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 246 titer | Standard Deviation 450 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 400 titer | Standard Deviation 458 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 3430 titer | Standard Deviation 15370 |
| Cohort 3 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 1372 titer | Standard Deviation 2418 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 1300 titer | Standard Deviation 4188 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 459 titer | Standard Deviation 420 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 1715 titer | Standard Deviation 4974 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 3676 titer | Standard Deviation 9816 |
| Cohort 4 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 857 titer | Standard Deviation 1315 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 14 | 3200 titer | Standard Deviation 17160 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 28 | 1532 titer | Standard Deviation 6991 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Baseline (Day -1) | 497 titer | Standard Deviation 3137 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 56 | 1131 titer | Standard Deviation 12550 |
| Cohort 5 | Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen | Day 7 | 951 titer | Standard Deviation 6276 |