Shigella WRSS1 Vaccine Trial in Bangladesh
Condition: Diarrhea
MeSH terms: Diarrhea
Intervention: Shigella sonnei Strain WRSS1 Vaccine; Placebo
Intervention description: Live attenuated, oral Shigella WRSS1 vaccine; Sterile saline solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 12 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: shigellosis; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Summary:

      This is a research study of an experimental (investigational) live attenuated Shigella sonnei
      vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune
      response. Shigella causes bloody and watery diarrhea, and infants and children living in
      developing countries experience the greatest consequences of this disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female children aged between 12 to 24 month of age at the time of vaccination

          2. General good health as determined by the screening evaluation no greater than 30 days
             before admission

          3. Father, mother or other legally acceptable representative (guardian) properly informed
             about the study, able to understand it and sign the informed consent form

          4. Normal bowel habits (< 3 grade 1 or 2 stools each day; ≥ 1 grade 1 or 2 stools every 2
             days)

          5. Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          6. Parent or guardian available for the entire period of the study and reachable by study
             staff throughout the entire follow-up period.

          7. Signed Informed Consent from the Parent or legal guardian

        Exclusion Criteria:

          1. Presence of a significant medical that in the opinion of the Investigator precludes
             participation in the study

          2. Known infection with human immunodeficiency virus (HIV)

          3. Presence in the serum of hepatitis A virus (HAV) or hepatitis C virus (HCV) antibody.

          4. History of congenital abdominal disorders, intussusception, abdominal surgery or any
             other congenital disorder.

          5. 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 child has been or will be exposed to an investigational or a
             non-investigational product

          6. Clinically significant abnormalities on physical examination

          7. Clinically significant abnormalities in screening hematology, serum chemistry as
             determined by the PI or the PI in consultation with the Study Physician

          8. History of febrile illness within 48 hours prior to vaccination

          9. Known or suspected impairment of immunological function based on medical history and
             physical examination

         10. Prior receipt of any Shigella vaccine

         11. Fever at the time of immunization. Fever is defined as a temperature ≥ 37.5C (99.5F)
             on axillary, oral, or tympanic measurement

         12. History of known shigellosis, chronic diarrhea/dysentery in the past 2 months

         13. Current use of iron or zinc supplements within the past 7 days; current use of
             antacids (H2 blockers, omeprazol, OTC agents) or immunosuppressive drug

         14. Allergy to quinolone, sulfa, and penicillin classes of antibiotics

         15. Clinical evidence of active gastrointestinal illness

         16. Prior receipt of a blood transfusion or blood products, including immunoglobulins

         17. 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.

         18. History of any neurologic disorders or seizures.

         19. Acute disease at the time of enrolment

         20. Medically significant malnutrition, defined as moderate malnutrition (wt-for-age
             z-score between -3.0 and -2.0) and severe malnutrition (wt-for-age z-score <-3.0 or
             edema)

         21. 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

         22. Receipt of antimicrobial drugs for any reason or a fever ≥ 38C within 7 days before
             vaccination

         23. History of diarrhea during the 7 days before vaccination.

         24. Has any household member(s) who is immunocompromised or under the age of 1 year old.

         25. Culture or polymerase chain reaction (PCR) positive for any Shigella strain