Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects

Summary

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.

Timeline

Start

2008-06-02

Primary completion

2010-05-30

Completion

2010-12-31

Publications

• Chen WH, Garza J, Choquette M, Hawkins J, Hoeper A, Bernstein DI, Cohen MB. Safety and immunogenicity of escalating dosages of a single oral administration of peru-15 pCTB, a candidate live, attenuated vaccine against enterotoxigenic Escherichia coli and Vibrio cholerae. Clin Vaccine Immunol. 2015 Jan;22(1):129-35. doi: 10.1128/CVI.00560-14. Epub 2014 Nov 19.

Drugs

Indications