Status:
COMPLETED
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
Lead Sponsor:
PATH
Conditions:
Shigellosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 dise...
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01509846
Start Date
March 1 2011
End Date
December 1 2012
Last Update
August 11 2021
Active Locations (2)
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1
Center for Immunization Research (CIR) at Johns Hopkins School of Public Health (JHSPH)
Baltimore, Maryland, United States, 21224
2
Johns Hopkins University CIR Isolation Unit
Baltimore, Maryland, United States, 21224