Safety Study of Live Attenuated Oral Shigella (WRSS1) Vaccine in Bangladeshi Adults and Children

Inclusion Criteria

• Healthy male or female adults from 18-39 years old, inclusive
• General good health as determined by the screening evaluation no greater than 30 days before admission
• Properly informed about the study, able to understand it and sign the informed consent form
• Normal bowel habits (< 3 grade 1 or 2 stools each day; ≥ 1 grade 1 or 2 stools every 2 days)
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Available for the entire period of the study and reachable by study staff throughout the entire follow-up period
• Females of childbearing potential who are willing to take a serum pregnancy test at screening and urine pregnancy tests before each vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable.
• Signed Informed Consent

Exclusion Criteria

• Presence of a significant medical or psychiatric condition that in the opinion of the Investigator precludes participation in the study
• Known infection with Hepatitis C or Human Immunodeficiency Virus (HIV)
• History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder.
• Participation in research involving another investigational product (defined as receipt of investigational product) 30 days before planned date of first vaccination or concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product
• Clinically significant abnormalities on physical examination
• Clinically significant abnormalities in screening hematology, serum chemistry, or urinalysis as determined by the PI or the PI in consultation with the Study Physician
• History of febrile illness within 48 hours prior to vaccination
• Known or suspected impairment of immunological function based on medical history and physical examination
• Prior receipt of any Shigella vaccine
• Fever at the time of immunization. Fever is defined as a temperature ≥ 37.5 degrees Celsius (99.5 degrees Fahrenheit) on axillary, oral, or tympanic measurement
• Clinical evidence of active gastrointestinal illness
• Prior receipt of a blood transfusion or blood products, including immunoglobulins
• Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment
• Evidence of current excessive alcohol consumption
• Evidence of current illicit drug use or drug dependence
• Current use of iron or zinc supplements within the past 7 days; current use of antacids (Histamine H2-receptor antagonists (H2 blockers), Omeprazole, over the counter (OTC) agents) or immunosuppressive drug
• Allergy to quinolone, sulfa, and penicillin classes of antibiotics
• History of any of the following conditions within the past 10 years:
• Arthritis (two or more episodes of joint pain and swelling)
• Gastrointestinal disease (diagnosed by a doctor as having irritable bowel disease, Crohn's disease, ulcerative colitis (biopsy confirmed), celiac disease, stomach or intestinal ulcers
• Dyspepsia (indigestion or heartburn requiring medication more than once per week)
• History of gallbladder disease
• History of chronic heart disease
• Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
• Receipt of antimicrobial drugs for an