ACE527 Safety and Immunogenicity Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00901654|
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : January 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Enterotoxigenic E. Coli (ETEC) Infection||Biological: ACE527 vaccine Biological: Placebo vaccine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|