ACE527 Safety and Immunogenicity Study
|Enterotoxigenic E. Coli (ETEC) Infection||Biological: ACE527 vaccine Biological: Placebo vaccine||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase I, Single Center, Double-Blind, Placebo-controlled Dose Finding Clinical Study to Evaluate the Safety and Immunogenicity of the Live Attenuated, Oral Vaccine ACE527|
- Adverse Events and determination of systemic immune response and mucosal immune response [ Time Frame: 13 weeks ]
- Assessing intestinal colonization by the vaccine ACE527 [ Time Frame: 13 weeks ]
|Study Start Date:||June 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Biological: ACE527 vaccine
First cohort: Two doses, each of 3x10^9 cfu of each strain (9x10^9 cfu total per dose) administered on Days 0 and Day 21 (out-patient).
Second cohort: Two doses, each of 3x10^10 cfu of each strain (9x10^10 cfu total per dose) administered on Days 0 and Day 21
|Placebo Comparator: Placebo comparator||
Biological: Placebo vaccine
First and second cohort: The placebo vaccine will be administered at Days 0 and Days 21.
The study is a phase I, single center, double-blind, placebo-controlled dose finding clinical study to evaluate the safety, tolerability and immunogenicity of the live attenuated, oral vaccine ACE527. The study is designed to evaluate 2 doses of the ACE527 in 2 cohorts. Each cohort will consist of approximately 18 subjects (healthy subjects), approximately 12 of them receiving ACE527 and approximately 6 receiving placebo.
Within a cohort, the second dose will only be given if safety and tolerability of the first dose is acceptable. This assessment will be based on evaluation of data up until Day 7 by the Independent Safety Committee (ISC) as per written guidance. The first dose of each cohort will be administered during an inpatient stay. Escalation to the next dose level will be dependent on an acceptable safety profile of the first dose at the previous dose level, based on evaluation of safety data by an Independent Safety Committee (ISC). The decision to administer the second dose at the higher level will also require review of the safety and tolerability of the second dose at the lower level.
The second dose will be administered at the outpatient clinic and the subjects will be observed for at least 60 minutes after vaccination prior to discharge from unit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901654
|United States, Maryland|
|Center for Immunization Research CIR|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Clayton Harro, MD||Johns Hopkins Bloomberg School of Public Health|