Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh

Adults

Inclusion Criteria

• Healthy male or female adults 18-45 years old, inclusive
• General good health as determined by the screening evaluation no greater than 7days before enrollment and vaccination
• Properly informed about the study, able to understand it and sign or thumb print the informed consent form
• 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 urine pregnancy test at screening and before the second 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.
• Informed Consent (signature or thumb print provided, with witness signature)

Exclusion Criteria

• Presence of any significant known 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 congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment
• Screening positive with hepatitis B antigen and/or hepatitis C antibodies
• Participation in research involving another investigational product (defined as receipt of investigational product) during the 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 in screening hematology or serum chemistry, as determined by the Study Physician
• History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement)
• Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine
• Prior receipt of a blood transfusion or blood products, including immunoglobulins
• 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 (H2 blockers, omeprazole, over-the-counter (OTC) agents) or immunosuppressive drug
• Any condition 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 within 14 days before vaccination
• History of diarrhea during the 7 days before vaccination (see protocol definition of diarrhea)
• Culture positive for ETEC, Shigella, V. Cholerae or Salmonella within 7 days before vaccination.
• Acute disease at the time of enrollment or 3 days prior to enrollment
• History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids.

Children, Toddlers and Infants Inclusion Criteria

• Healthy male or female infants/toddlers/children ages:
• Part B: >24 and ≤59 months old at the time of enrollment
• Part C: ≥12 and <24 months old at the time of enrollment
• Part D: ≥6 and <12 months at the time of enrollment
• General good health as determined by the screening evaluation no greater than 7 days before enrollment and vaccination
• Parent properly informed about the study, able to understand it