A Phase 1 Dose Escalating Study of Two Enterotoxigenic Escherichia Coli Prototype Adhesin-based Vaccines With or Without Modified Heat-labile Enterotoxin by Intradermal or Transcutaneous Immunization
Sponsor study identifier
Secondary identifiers
OTHER · Sponsor
OTHER · Naval Medical Research Center Institutional Review Board
OTHER · Walter Reed Army Institute of Research Institutional Review Board
interventional
57
1 country
1
Study Start
August 2012
Actual (reported)Primary Completion
June 2014
Actual (reported)Study Completion
June 2015
Actual (reported)The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
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.
July 11, 2012
Actual (reported)July 19, 2012
Actual (reported)August 2012
Actual (reported)June 2014
Actual (reported)June 2015
Actual (reported)July 8, 2019
Actual (reported)Safety - Occurrence of Adverse Events
Occurrence of related and unrelated to vaccine AE's
1 year
Number of Participants With Immune Responses to Vaccine Antigens
baseline and post dose
Antigen-Specific IgA Geometric Mean Titers
Day 0, 21,42, 56, 70
Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Walter Reed Army Institute of Research Clinical trial Center
Silver Spring, Maryland, 20910, United States
Ramiro L. Gutierrez, MD, MPH
Enteric Diseases Department, Naval Medical Research Center
57 participants (actual enrollment reported by the registry).
First Submitted
July 11, 2012
First Posted
July 19, 2012
Study Start
August 2012
Actual (reported)Primary Completion
Multi-Drug Resistant Organism (MDRO): Study of Highly Resistant Escherichia Coli
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1250 ug dscCfaE + 50 ng LTR192G TCI 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.
Contact the study team to confirm eligibility.
June 2014
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
February 12, 2021
Results First Posted
July 8, 2019
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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