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Report for Clinical Trial NCT03548064
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin
LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or
intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years. Study
duration is approximately 2.5 years, with each participant duration for up to 9 months
depending on the route of dmLT administered. There is no specific hypothesis being tested in
this study. The primary objective of this study is to assess the reactogenicity, safety, and
tolerability of dmLT when administered in three sequential doses, over a range of dosages by
oral, sublingual, or intradermal routes.
NCT03548064 Gastroenteritis Escherichia Coli Immunisation
6 Interventions
Name: Placebo
Description: Placebo
Type: Other
Group Labels: 3 Regimen A Regimen B Regimen G
Name: Placebo
Description: Placebo
Type: Other
Group Labels: 3 Regimen C Regimen D Regimen H
Name: Placebo
Description: Placebo
Type: Other
Group Labels: 3 Regimen E Regimen F Regimen I
Name: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Description: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
Type: Biological
Group Labels: 3 Regimen A Regimen B Regimen G
Name: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Description: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
Type: Biological
Group Labels: 3 Regimen C Regimen D Regimen H
Name: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Description: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
Type: Biological
Group Labels: 3 Regimen E Regimen F Regimen I
Primary Outcomes
Measure: The occurrence of discontinuation of study vaccination Time: Day 1 up to day 223
Measure: The occurrence of solicited local site events Time: Day 1 to day 8
Measure: The occurrence of solicited local site events Time: Day 15 to day 36
Measure: The occurrence of solicited local site events Time: Day 43 to day 50
Measure: The occurrence of study withdrawals Time: Day 1 up to day 223
Measure: The occurrence of systemic reactogenicity events Time: Day 1 to day 8
Measure: The occurrence of systemic reactogenicity events Time: Day 15 to day 36
Measure: The occurrence of systemic reactogenicity events Time: Day 43 to day 50
Measure: The occurrence of unsolicited vaccine-related adverse events (AE), including laboratory AE Time: Day 1 to day 71
Secondary Outcomes
Measure: The occurrence of vaccine-related serious adverse events (SAE) Time: Day 1 up to day 223
Measure: The proportion of participants with = / > 2-fold rise in ALS anti-dmLT-specific IgA titers over baseline measured by ELISA Time: Day 1 to day 114
Measure: The proportion of participants with = / > 2-fold rise in ALS anti-dmLT-specific IgG titers over baseline measured by ELISA Time: Day 1 to day 114
Measure: The proportion of participants with >8 dmLT-specific IgA or IgG ASC / 10^6 PBMC as measured by ELISpot Time: Day 1 to day 114
Measure: The proportion of participants with a = / > 4-fold rise in dmLT-specific serum IgA titers over baseline measured by ELISA Time: Day 1 to day 114
Measure: The proportion of participants with a = / > 4-fold rise in dmLT-specific serum IgG titers over baseline measured by ELISA Time: Day 1 to day 114
Measure: The proportion of participants with a = / > 4-fold rise over baseline in dmLT-specific fecal IgA titers measured by ELISA Time: Day 1 to day 57
Measure: The proportion of participants with a = / > 4-fold rise over baseline in dmLT-specific salivary IgA titers measured by ELISA Time: Day 1 to day 57
Purpose: Prevention
Allocation: Randomized
Sequential Assignment
There is one SNP
SNPs
A Phase 1 Double-Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Oral, Sublingual, or Intradermal Vaccination in Adults Residing in an Endemic Area. --- L211A ---
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin
LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or
intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years. --- L211A ---
Gastroenteritis Escherichia Coli
Immunisation
Gastroenteritis
This is a Phase 1 double-blinded, placebo-controlled, dose-escalation trial to evaluate the
safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from
Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in
approximately 135 healthy adult volunteers, age 18-45 years, who meet all the eligibility
criteria and reside in Bangladesh. --- L211A ---
HPO Nodes