- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01509846
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
August 10, 2021 updated by: PATH
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Oral Inactivated Whole Cell Shigella Flexneri 2a Vaccine in Healthy Adult Subjects
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC).
Sf2aWC is a killed vaccine that is being made to prevent disease from Shigella., which causes bloody, watery diarrhea.
Infants and children living in developing countries experience the greatest consequences of this disease.
The purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops an immune response.
About 82 healthy adults, ages 18-45, will participate in this study.
This study will require volunteers to stay in the research facility for several nights for the first dose.
Participants in Cohorts 2, 3, and 4 will not be required to stay overnight for the second and third doses.
Participants will be assigned to receive 1 of 4 vaccine doses by mouth.
Study procedures include: stool samples, blood samples and documenting side effects.
Participants will be involved in study related procedures for about 8 months.
Study Overview
Status
Completed
Conditions
Detailed Description
Despite the public health burden of Shigella spp. on travelers, deployed soldiers and, most significantly, young children in the developing world, there is no licensed vaccine against Shigella.
The rationale for using Shigella flexneri 2a whole cell killed vaccine (Sf2aWC), is that it is expected to be especially well tolerated by subjects.
If Sf2aWC is safe and immunogenic, it may be combined with S. sonnei and S. flexneri 3a as the basis of a multivalent vaccine, because these three components should cover up to 80% of shigella infections in developing countries and over 90% in developed countries.
This is a single site, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study in healthy adult subjects.
Approximately 82 subjects will be enrolled into four separate cohorts and will be randomized to receive Sf2aWC or placebo.
The placebo preparation will be bicarbonate buffer.
Cohort 1 subjects will receive a single oral dose of Sf2aWC (2.6±0.8 x 10^8 vp/mL) or placebo.
Dosing and 72 hours of supervised post-vaccination safety follow-up will be conducted in the Center for Immunization Research, Johns Hopkins School of Public Health (CIR) Inpatient Unit.
Before enrolling subjects in subsequent cohorts, safety data from the previous Cohort(s) through Study Day 7 will be evaluated and reviewed by the Safety Review Committee (SRC).
Cohorts 2, 3, and 4 participants will receive three doses of Sf2aWC vaccine or placebo at 0, 1 and 2 months.
The first immunization will be administered in the CIR inpatient unit, followed by 72 hours of direct post-immunization observation.
If after review by the SRC the first dose appears safe and well tolerated, subsequent doses will be administered on an outpatient basis.
Safety will be assessed by solicited symptoms/subject memory aid and laboratory evaluations.
Adverse events (AE)s will be graded according to standardized criteria.
The immunogenicity outcome measures of interest include serum immunoglobulin G (IgG) and immunoglobulin A (IgA) antibodies by ELISA against S. flexneri 2a Lipopolysaccharide (LPS) and S. flexneri 2a invasive protein antigens (Ipa), cytokine assays, B and T cell memory responses, and vaccine-specific IgA responses.
The proposed sample size of twenty per group in Cohorts 2, 3, and 4 would be sufficient to select the appropriate dose to move into the next study phase, providing that a difference in the immunogenicity between the two arms is 20% or greater.
Participants will include 82 healthy adult male and female subjects, ages 18 to 45 inclusive.
The primary objective of this study is to assess the safety and tolerability of Sf2aWC vaccine when administered in three oral doses over a range of dose levels in healthy adult subjects.
The secondary objective is to assess the immunogenicity of the Sf2aWC vaccine over a range of doses in healthy adult subjects.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Center for Immunization Research (CIR) at Johns Hopkins School of Public Health (JHSPH)
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins University CIR Isolation Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults, male or female, age 18 to 45 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved >70% accuracy).
- Signed informed consent form.
- Available for the required follow-up period and scheduled clinic visits.
- Negative urine pregnancy test before each vaccination for female subjects 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 also acceptable.
Exclusion Criteria:
- Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study. Some medical conditions, that are adequately treated and stable, would not preclude entry into the study. These conditions might include stable asthma, hypertension or depression controlled with medication.
- Clinically significant abnormalities on physical examination.
- Clinically significant abnormalities in screening hematology, serum chemistry, or urinalysis as determined by PI or PI in consultation with Medical Monitor.
- History of febrile illness within 48 hours prior to vaccination.
- BMI <19 or >34.
- Positive blood test for HBsAG, hepatitis C virus (HCV), HIV-1, Human leukocyte antigen (HLA)-B27.
- Women currently nursing.
- History of reactive arthritis.
- Evidence of current excessive alcohol consumption
- Evidence of current drug use or drug dependence.
- Regular use of anti-diarrheal, anti-constipation, or antacid therapy (excluding use associated with spicy meals).
- Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis.
- Personal or family history of an inflammatory arthritis.
- History of allergy to soy products.
- History of microbiologically confirmed Shigella infection within 3 years.
- Prior receipt of experimental Shigella vaccine or live Shigella challenge within 3 years.
- Symptoms of travelers' diarrhea associated with travel to countries where Shigella or other enteric infections are endemic (most of the developing world) within 1 year prior to dosing.
- Occupation involving handling of Shigella bacteria currently, or in the past 3 years.
- History of diarrhea during the 7 days before vaccination.
- Use of antibiotics during the 7 days before vaccination.
- Use of proton pump inhibitors, H2 blockers, or antacids within 48 hours prior to dosing.
- Inability to comply with inpatient rules and regulations.
- Use of immunosuppressive and/or immunomodulative drugs such as corticosteroids or chemotherapeutics that may influence antibody development.
- Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Received one oral dose of 2.6±0.8
x 10^8 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
|
Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8
x 10^8 vp/mL administered on Day 0
|
Experimental: Cohort 2
Received three oral doses of 2.6±0.8
x 10^9 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
|
Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8
x 10^9 vp/mL administered on Days 0, 28, and 56
|
Experimental: Cohort 3
Received three oral doses of 2.6±0.8
x 10^10 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
|
Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8
x 10^10 vp/mL administered on Days 0, 28, and 56
|
Experimental: Cohort 4
Received three oral doses of 2.6±0.8
x 10^11 vp/mL Shigella flexneri 2a whole cell killed vaccine (Sf2aWC)
|
Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8
x 10^11 vp/mL administered on Days 0, 28, and 56
|
Placebo Comparator: Placebo
Received oral dose of placebo concurrent with Cohort 1 (one dose), 2, 3, or 4 (3 doses).
|
Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Reactogenicity Per Subject and Treatment Group
Time Frame: 7 days after each vaccination (Day 0, Day 35, Day 63)
|
Local and systemic reactogenicity was assessed post-vaccination using targeted physical examinations, vital signs and clinical laboratory tests, and diary cards (completed following discharge daily through Day 7).
Reactogenicity included: nausea, vomiting, fever, abdominal pain, abdominal cramping, bloating, malaise, headache, decreased appetite, generalized myalgias, chills, light-headedness, constipation, excessive flatulence, reactive arthritis, dysentery, loose stool, diarrhea, hypovolemia, joint pain, defecation urgency, and oral temperature.
|
7 days after each vaccination (Day 0, Day 35, Day 63)
|
Frequency of Unsolicited Adverse Events With a Reasonable Possibility That the Study Product Caused the Event
Time Frame: 6 months after final vaccination (Day 168 or Day 224)
|
6 months after final vaccination (Day 168 or Day 224)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Time Frame: 35 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
35 days
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Time Frame: 63 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
63 days
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 3
Time Frame: 35 days
|
S. flexneri 2a LPS were used as the ELISA antigens.
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
35 days
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response in Cohort 4
Time Frame: 63 days
|
S. flexneri 2a LPS were used as the ELISA antigens.
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
63 days
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Time Frame: 16 weeks
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
16 weeks
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Time Frame: 16 weeks
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
16 weeks
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 3
Time Frame: 35 days
|
S. flexneri 2a LPS were used as the ELISA antigens.
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
35 days
|
Geometric Mean Titer (GMT) of Serum Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response in Cohort 4
Time Frame: 16 weeks
|
S. flexneri 2a LPS were used as the ELISA antigens.
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
16 weeks
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Time Frame: 63 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
63 days
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin A (IgA) Response From Baseline
Time Frame: 63 days
|
S. flexneri 2a LPS were used as the ELISA antigens.
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
63 days
|
Number and Percentage of Subjects With Positive Immunologic Response in Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response From Baseline
Time Frame: 63 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
63 days
|
Geometric Mean Titer (GMT) of Serum Antibody From Lymphocytes Supernatant (ALS) Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Response
Time Frame: 63 days
|
S. flexneri 2a LPS were used as the ELISA antigens.
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
63 days
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Time Frame: 63 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
63 days
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigens B (IpaB) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Time Frame: 63 days
|
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant).
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
63 days
|
Number and Percentage of Subjects With Positive Immunologic Response in Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response From Baseline
Time Frame: 63 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
63 days
|
Geometric Mean Titer (GMT) of Invasion Plasmid Antigen D (IpaD) Lymphocytes Supernatant (ALS) Immunoglobulin A (IgA) Response
Time Frame: 63 days
|
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant).
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
63 days
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Time Frame: 16 weeks
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
16 weeks
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 3
Time Frame: 16 weeks
|
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
16 weeks
|
Number and Percentage of Subjects in Cohort 3 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Time Frame: 16 weeks
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
16 weeks
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 3
Time Frame: 16 weeks
|
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant).
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
16 weeks
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Total Immunoglobulin A (IgA) Response From Baseline
Time Frame: 63 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
63 days
|
Geometric Mean Titer (GMT) of Total Immunoglobulin A (IgA) Response in Cohort 4
Time Frame: 63 days
|
Whole blood samples were collected for determination of ALS (antibody from lymphocytes supernatant).
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
63 days
|
Number and Percentage of Subjects in Cohort 4 With Positive Immunologic Response in Fecal Immunoglobulin A (IgA) Response From Baseline
Time Frame: 63 days
|
A positive immunological response is defined as an increase of 4-fold or more over the appropriate baseline value for ALS or an increase of more than 2-fold for serological responses (fold increases will be calculated to 1 decimal place).
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
The fold-change in response was then calculated as the ratio of each value to the baseline value (so the minimum baseline value was 0.14).
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
|
63 days
|
Geometric Mean Titer (GMT) of Fecal Immunoglobulin A (IgA) Response in Cohort 4
Time Frame: 63 days
|
Immunogenicity responses are presented for Cohorts 3 and 4 only.
Specimens from vaccine recipients in Cohorts 1 and 2 were not tested for immunogenicity data and no data were collected.
For all immunology variables, the raw values were first adjusted to the geometric mean of positive controls, and any values <0.15 were changed to 0.14.
|
63 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clayton D Harro, MD, ScM, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 5, 2012
First Submitted That Met QC Criteria
January 10, 2012
First Posted (Estimate)
January 13, 2012
Study Record Updates
Last Update Posted (Actual)
August 11, 2021
Last Update Submitted That Met QC Criteria
August 10, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Enterobacteriaceae Infections
- Dysentery
- Dysentery, Bacillary
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- VAC 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shigellosis
-
GlaxoSmithKlineRecruiting
-
Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdRecruiting
-
PATHUnited States Department of Defense; Johns Hopkins University Center for Immunization...Completed
-
LimmaTech Biologics AGKEMRI-Wellcome Trust Collaborative Research Program; Kenya Medical Research...Completed
-
International Centre for Diarrhoeal Disease Research...Karolinska Institutet; Swedish International Development Cooperation Agency...Completed
-
University of OxfordJohns Hopkins University; Walter Reed Army Institute of Research (WRAIR); KEMRI-Wellcome... and other collaboratorsNot yet recruiting
-
Intralytix, Inc.University of Maryland, BaltimoreRecruiting
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; University of WashingtonRecruiting
-
GSK Vaccines Institute For Global Health S.r.l.Completed
-
GlycoVaxyn AGCompleted
Clinical Trials on Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose
-
University of OxfordNational Institute of Allergy and Infectious Diseases (NIAID); Wellcome TrustCompletedEbola | Ebola ZaireUnited Kingdom
-
S.Biomedics Co., Ltd.Dt&SanomedicsActive, not recruitingCritical Limb IschemiaKorea, Republic of
-
Crucell Holland BVThe PATH Malaria Vaccine Initiative (MVI); Seattle Children's Research Institute...Completed
-
Merck Sharp & Dohme LLCCompleted
-
Janssen Vaccines & Prevention B.V.Completed
-
Merck Sharp & Dohme LLCTerminated
-
University of OxfordNational Institute for Health Research, United Kingdom; The PATH Malaria Vaccine...CompletedPlasmodium Falciparum MalariaUnited Kingdom
-
University of Michigan Rogel Cancer CenterRush University Medical CenterCompletedPancreatic CancerUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Kidney Wilms Tumor | Stage IV Kidney Wilms TumorUnited States, Canada, Australia, New Zealand, Puerto Rico, Israel, Switzerland
-
National Cancer Institute (NCI)CompletedStage IV Adult Soft Tissue Sarcoma | Adult Rhabdomyosarcoma | Metastatic Childhood Soft Tissue Sarcoma | Childhood Alveolar Rhabdomyosarcoma | Childhood Embryonal Rhabdomyosarcoma | Untreated Childhood RhabdomyosarcomaUnited States, Canada, Australia, New Zealand