A Phase 1 Dose-Escalating Study of dscCfaE, Co-Administered With and Without LTR192G, by Transcutaneous Immunization (TCI) in Healthy Adult U.S. Volunteers
Sponsor study identifier
Secondary identifiers
OTHER · Naval Medical Research Center
OTHER · Walter Reed Army Institute of Research
interventional
40
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
April 2013
Actual (reported)The purpose of the study is to determine if immunization with a recombinant E. coli protein, dscCfaE, is safe and immunogenic when administered through the skin using a patch.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2011
Actual (reported)June 27, 2011
Actual (reported)July 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 2012
Actual (reported)April 2013
Actual (reported)Number of adverse events
Adverse event monitoring will survey and specifically inquire about fever (oral temperature \> 100.4 o F), malaise, headache, rash, pain, diarrhea, abdominal pain, extremity pain or swelling. Clinical definitions will be used to grade severity of symptoms in accordance to the severity scale below: Grade 0 = None Grade 1= Barely noticeable Grade 2= Noticeable, does not interfere with daily activities Grade 3=Interferes with daily activities Grade 4=Prevents daily activities
Days 0 - 180
Number of Seroconversion to LT and dscCfaE; defined as a > 4-fold increase in endpoint titer between pre-and post-vaccination samples.
Study Days 0 - 180
Number of Mucosal responses (fecal IgA); defined as a > 4-fold increase in endpoint titer after adjusting for total IgA.
Study Days 0 - 180
Number of positive IgA-ASC responses; defined as a > 2-fold increase over th e baseline value of the ASC per 10 6 PBMC, when the number of ASC is > 0.5 per 10 6 in the baseline sample
Study Days 0 - 180
10 ug on study days 0, 21 and 42
50 ug on study days 0, 21 and 42
Walter Reed Army Institute of Research Clinical Trial Center
Silver Spring, Maryland, 20910, United States
Mark S. Riddle, MD, DrPH
Naval Medical Research Center
40 participants (actual enrollment reported by the registry).
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Multi-Drug Resistant Organism (MDRO): Study of Highly Resistant Escherichia Coli
250 ug on study days 0, 21 and 42
50 ug on study days 0, 21 and 42
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 2012
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
April 27, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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