Status:
COMPLETED
Safety Study of Live Attenuated Oral Shigella (WRSS1) Vaccine in Bangladeshi Adults and Children
Lead Sponsor:
PATH
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Diarrhea
Eligibility:
All Genders
5-39 years
Phase:
NA
Brief Summary
This is a research study about an experimental (investigational) oral Shigella sonnei - Walter Reed S. sonnei (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, whic...
Detailed Description
This is a single site, double-blind, randomized, placebo-controlled, dose-escalation, age-descending study that will start testing the vaccine in healthy adults and move subsequently into school-age c...
Eligibility Criteria
Inclusion
- 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
- 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 any reason or a fever ≥ 38 degrees Celsius within 7 days before vaccination
- History of diarrhea during the 7 days before vaccination.
- Has any household member(s) who is immunocompromised or under the age of 2 years old.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01813071
Start Date
August 1 2013
End Date
April 1 2016
Last Update
February 8 2019
Active Locations (1)
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1
Icddr,B
Dhaka, Bangladesh