Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects
Completed
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 1
2008-06-02
Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's
diarrhea and are significant pathogens affecting children and elderly individuals of
developing countries. The purpose of the study is to determine the safety of the ETEC-Cholera
vaccine and the body's ability to protect itself against ETEC and cholera infection after
receiving the vaccine. The study will enroll a total of 64 healthy volunteers, 18 to 45 years
old at the Cincinnati Children's Hospital. The study will provide increasing doses of the
vaccine or placebo (inactive substance) to 4 groups consisting of 16 participants each.
Participants will remain in the inpatient unit for observation for about 11 days. All
subjects will be treated with Cipro, an antibiotic, for 5 days. Study procedures include:
blood samples, vital signs, physical examinations, and stool samples. Volunteers will be
involved in the study for about 8 months including telephone contacts.
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