Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects
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
1 other identifier
interventional
62
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 7, 2008
CompletedStudy Start
First participant enrolled
June 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2010
CompletedJuly 29, 2021
February 9, 2010
2 years
April 3, 2008
July 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events (AEs) will be graded according to standardized criteria.
Through the Day 28 post-vaccination visit.
Safety: physical examinations, interim medical history, solicited symptoms/subject memory aid, and laboratory evaluations.
Through the Day 28 post-vaccination visit.
Secondary Outcomes (2)
Immunogenicity will be assessed by changes in vibriocidal antibody titer, anti-Cholera toxin B-subunit antibody titer, and anti-Labile toxin antibody titer.
Days -1, 7, 10, 14, and 28.
Stool shedding of the vaccine organisms will be assessed by qualitative and quantitative cultures.
Qualitative: Days 1-10, 14, 21, 28: Quantitative: Days 1-10.
Study Arms (4)
Cohort 1: vaccine dosage level 1 or placebo
EXPERIMENTALVaccine dose level 1: 1 X 10\^7 colony forming unit (CFU) or placebo, treated with Cipro on days 7-11.
Cohort 2: vaccine dosage level 2 or placebo
EXPERIMENTALVaccine dose level 2: 1 X 10\^8 CFU or placebo, treated with Cipro on days 7-11.
Cohort 3: vaccine dosage level 3 or placebo
EXPERIMENTALVaccine dose level 3: 1 X 10\^9 CFU or placebo, treated with Cipro on days 7-11.
Cohort 4: vaccine dosage level 4 or placebo
EXPERIMENTALVaccine dose level 4: 1 X 10\^10 CFU or placebo, treated with Cipro on days 7-11.
Interventions
500 milligrams(mg) will be administered orally twice daily for 5 days.
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.
Buffer solution: 2.5 grams (g) Sodium Bicarbonate powder, 1.65 g Ascorbic Acid and 25 mg Aspartame, in 100 milliliters (mL) water for injection.
Eligibility Criteria
You may qualify if:
- Male or female age 18-45, inclusive. -Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, vital signs, screening laboratories, and medication history. -Capable of understanding, consenting and complying with the entire study protocol including the inpatient period. -Female subjects must be of non-childbearing potential, or if of childbearing potential (as determined by the investigator) must be practicing abstinence or using an effective licensed method of birth control (e.g., oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit. -Male subjects must agree not to father a child during the study and for 90 days after the Day 0 study visit. -Provide voluntary written informed consent and attained at least 70% on an examination about the study on the first attempt. -Have normal screening laboratories for serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT), creatinine, sodium, potassium, total white blood count (WBC), hemoglobin, neutrophils, lymphocytes, platelets, urine protein, urine glucose and urine red blood cells (RBC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3039, United States
Related Publications (1)
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.
PMID: 25410205DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 7, 2008
Study Start
June 2, 2008
Primary Completion
May 30, 2010
Study Completion
December 31, 2010
Last Updated
July 29, 2021
Record last verified: 2010-02-09