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Report for Clinical Trial NCT02531685

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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
MeSH: Gastroenteritis

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


1 L211A

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