Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00654108 |
Enterotoxigenic Escherichia (E.) coli (ETEC) 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 against the E. coli responsible for the diarrhea. The study will enroll a total of 64 healthy volunteers, 18 to 45 years old at the Cincinnati Children's Hospital. The study will look at increasing doses of the vaccine or placebo given to 4 groups of 16 subjects. Subjects will remain in the inpatient unit for observation study days -1 through 9 during which stool samples will be collected. Subjects will return to the clinic on study days 10, 14, 21, and 28 for required follow up. Subjects will be contacted by telephone months 2, 4, and 6 to assess for side effects of the study drug. All subjects will be treated with Cipro, an antibiotic, for 5 days. Subjects will participate in study related procedures for up to 8 months.
Condition | Intervention | Phase |
---|---|---|
Escherichia Coli Infections |
Drug: Ciprofloxacin 500 mg Biological: Peru-15-pCTB Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Dose Escalation, Inpatient Phase I Study to Determine the Safety and Immunogenicity of a Single Oral Dose of a Combined Live, Attenuated, Enterotoxigenic Escherichia Coli (ETEC)-Cholera Vaccine (Peru-15 pCTB) in Healthy Adult Subjects |
Estimated Enrollment: | 64 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1: vaccine dosage level 1 or placebo: Experimental
Vaccine dose level 1: 1 X 10^7 CFU or placebo, treated with Cipro on days 7-11.
|
Drug: Ciprofloxacin 500 mg
500 mg will be administered orally twice daily for 5 days.
Biological: Peru-15-pCTB
Live attenuated oral combined ETEC-cholera (Peru-15 pCTB) vaccine co-administered with bicarbonate buffer solution; vaccine dose levels 1 X 10^7; 1 X 10^8; 1 X 10^9; and 1 X 10^10.
Drug: Placebo
Buffer solution: 2.5 g Sodium Bicarbonate powder, 1.65 g Ascorbic Acid and 25 mg Aspartame, in 100 mL water for injection.
|
Cohort 2: vaccine dosage level 2 or placebo: Experimental
Vaccine dose level 2: 1 X 10^8 CFU or placebo, treated with Cipro on days 7-11.
|
Drug: Ciprofloxacin 500 mg
500 mg will be administered orally twice daily for 5 days.
Biological: Peru-15-pCTB
Live attenuated oral combined ETEC-cholera (Peru-15 pCTB) vaccine co-administered with bicarbonate buffer solution; vaccine dose levels 1 X 10^7; 1 X 10^8; 1 X 10^9; and 1 X 10^10.
Drug: Placebo
Buffer solution: 2.5 g Sodium Bicarbonate powder, 1.65 g Ascorbic Acid and 25 mg Aspartame, in 100 mL water for injection.
|
Cohort 3: vaccine dosage level 3 or placebo: Experimental
Vaccine dose level 3: 1 X 10^9 CFU or placebo, treated with Cipro on days 7-11.
|
Drug: Ciprofloxacin 500 mg
500 mg will be administered orally twice daily for 5 days.
Biological: Peru-15-pCTB
Live attenuated oral combined ETEC-cholera (Peru-15 pCTB) vaccine co-administered with bicarbonate buffer solution; vaccine dose levels 1 X 10^7; 1 X 10^8; 1 X 10^9; and 1 X 10^10.
Drug: Placebo
Buffer solution: 2.5 g Sodium Bicarbonate powder, 1.65 g Ascorbic Acid and 25 mg Aspartame, in 100 mL water for injection.
|
Cohort 4: vaccine dosage level 4 or placebo: Experimental
Vaccine dose level 4: 1 X 10^10 CFU or placebo, treated with Cipro on days 7-11.
|
Drug: Ciprofloxacin 500 mg
500 mg will be administered orally twice daily for 5 days.
Biological: Peru-15-pCTB
Live attenuated oral combined ETEC-cholera (Peru-15 pCTB) vaccine co-administered with bicarbonate buffer solution; vaccine dose levels 1 X 10^7; 1 X 10^8; 1 X 10^9; and 1 X 10^10.
Drug: Placebo
Buffer solution: 2.5 g Sodium Bicarbonate powder, 1.65 g Ascorbic Acid and 25 mg Aspartame, in 100 mL water for injection.
|
Enterotoxigenic Escherichia coli (ETEC) are the principal single cause of traveler's diarrhea and are a significant pathogen affecting children and elderly individuals of developing countries. ETEC infections result in approximately 600 million total cases of diarrhea worldwide annually, with an estimated 280 million cases and over 400,000 deaths in children less than 5 years of age. The proposed study is a randomized, double-blind, placebo controlled, dose-escalation, inpatient Phase I study to determine the safety and immunogenicity of a single oral dose of a combined live, attenuated, enterotoxigenic Escherichia coli (ETEC)-cholera vaccine (Peru-15 pCTB) in healthy adult subjects. A total of 64 healthy subjects, 18 to 45 years old will be enrolled in this study. Subject participation duration is up to 8 months. The volunteers will be placed in sequential cohorts of 16 eligible subjects and will be randomized in a 3:1 ratio to receive the assigned dose of ETEC-cholera vaccine or placebo (bicarbonate buffer only), respectively. The study will be conducted at Cincinnati Children's Hospital. Subjects will remain in the inpatient unit for observation study days -1 through 9. Subjects will return to the study clinic on study days 10, 14, 21, and 28 for required evaluations. Subjects will be contacted by telephone at 2, 4, and 6 months following study drug administration to assess for any new medications, changes in concomitant medication regimens (both prescription and over the counter medications), and the occurrence of adverse events. The primary objective of this study will be to assess the safety of a combined ETEC-cholera vaccine (Peru-15-pCTB) when administered as a single oral dose over a range of doses in healthy adult subjects compared to placebo at day 28 post-vaccination. The secondary objectives will be: to assess long-term safety follow-up from immunization through Month 6 post vaccination; to evaluate the immunogenicity of a single oral dose of ETEC-cholera vaccine over a range of doses in healthy adult subjects; and to evaluate the shedding profile of the ETEC-cholera vaccine organisms in stool for a period of 7 days. The primary endpoint of the study is the safety of ETEC-cholera vaccine as assessed by the incidence and severity of adverse events (AE) and changes in laboratory and clinical parameters through the day 28 post-vaccination visit. The secondary endpoints include immunogenicity as assessed by changes in vibriocidal antibody titer, anti-cholera toxin B-subunit antibody titer, and anti-labile toxin antibody titer.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 07-0052 |
Study First Received: | April 3, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00654108 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Federal Government; United States: Food and Drug Administration |
Escherichia coli, cholera, diarrhea, vaccine |
Vitamin C Bacterial Infections Anti-Infective Agents Ciprofloxacin Diarrhea Enterobacteriaceae Infections |
Escherichia coli Infections Cholera Healthy Ascorbic Acid Gram-Negative Bacterial Infections |
Bacterial Infections Anti-Infective Agents Ciprofloxacin Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enterobacteriaceae Infections |
Escherichia coli Infections Enzyme Inhibitors Infection Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Gram-Negative Bacterial Infections |