SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02531685
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia
coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT)
from ETEC, administered by the Intradermal (ID) route. The sample size has been determined
based on the historic sample, not on power calculations.The study will involve 99 subjects
(83 vaccinees and 16 placebo controls) in 4 consecutive cohorts of 16 individuals each (13
vaccinees and 3 placebo controls) and the final cohort of 35 (31 vaccinees and 4 placebos)
subjects. The primary objective is to assess the safety and tolerability of dmLT vaccine when
administered in three doses intradermally over a range of dosages in healthy adult subjects.
NCT02531685 Gastroenteritis Escherichia Coli
2 Interventions
Name: Placebo
Description: Placebo: 0.9% Sodium Chloride injection.Type: Other
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Name: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Description: LT(R192G/L211A), or dmLT is formulated as a freeze-dried (lyophilized), white to off-white cake, containing 700mcg of vaccine protein in a 3 ml, multi-dose.Type: Biological
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Primary Outcomes
Measure: Occurrence of solicited adverse events (AEs)
Time: 7 Days following each vaccination
Measure: Occurrence of vaccine-related, non-solicited adverse events (AEs)
Time: Day 43 through 73
Secondary Outcomes
Measure: Occurrence of vaccine-related serious adverse events (SAEs)
Time: Day 1 through 6 months after 3rd vaccination
Measure: Occurrence of vaccine-related, non-solicited adverse events (AEs)
Time: Day 1 through 6 months after 3rd vaccination
Measure: Proportion of subjects with > /=2-fold rise from the baseline in dmLT-specific toxin neutralization IgA-ALS titers
Time: Day 1 through Day 99
Measure: Proportion of subjects with > /=2-fold rise from the baseline in dmLT-specific toxin neutralization IgG-ALS titers
Time: Day 1 through Day 99
Measure: Proportion of subjects with > /=4-fold rise from the baseline in dmLT-specific fecal IgA titers
Time: Day 1 through Day 99
Measure: Proportion of subjects with > /=4-fold rise from the baseline in dmLT-specific serum IgA titers
Time: Day 1 through Day 99
Measure: Proportion of subjects with > /=4-fold rise from the baseline in dmLT-specific serum IgG titers
Time: Day 1 through Day 99
Measure: Proportion of subjects with > /=4-fold rise from the baseline in the ratio of dmLT-specific toxin neutralization titer of antigen-specific IgA over total IgA
Time: Day 1 through Day 99
Measure: Proportion of subjects with >8 IgA- or IgG-ASC/10^6 peripheral blood mononuclear cells (PBMCs)
Time: Day 1 through Day 99
Measure: Proportion of subjects with IgA dmLT-specific circulating ASC expressing gut homing receptors (integrin alpha4beta7 in the absence or presence of CD62L) in cohort 5 only
Time: Day 1 through Day 99
Measure: Proportion of subjects with IgG dmLT-specific circulating ASC expressing gut homing receptors (integrin alpha4beta7 in the absence or presence of CD62L) in cohort 5 only
Time: Day 1 through Day 99
Measure: Proportion of the subjects with B or T cell memory determined by EliSpot
Time: Day 1 through Day 99
Purpose: Prevention
Allocation: Randomized
Sequential Assignment
There is one SNP
SNPs
A Phase 1 Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Intradermal (ID) Vaccination in Healthy Adults. --- L211A ---
HPO Nodes