Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Shigellosis

In brief

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.

Key facts

Study ID

NCT01509846

Run by

PATH

People needed

82

Starts

2011-03-01

Expected to finish

2012-12-01

Last updated by the study team

2021-08-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Immunization Research (CIR) at Johns Hopkins School of Public Health (JHSPH) — Baltimore, Maryland, United States
• Johns Hopkins University CIR Isolation Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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