SNPMiner Trials (Home Page)
Report for Mutation L211A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 3 clinical trials
Clinical Trials
1 A Phase 1 Dose Escalating Study of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Sublingual or Oral Immunization to Determine Safety and Immunogenicity of a Multi-dose Regimen in Adult Humans
A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and immunogenicity of a multi-dose regimen in healthy adult volunteers. The study will be conducted at Cincinnati Children's Hospital Medical Center (CCHMC). The primary objectives assess the safety and tolerability of dmLT vaccine when administered in three doses sublingually over a range of dosages in healthy adult subjects. The secondary objectives assess long-term safety follow-up from immunization through Month 7 post vaccination, following three SL doses of dmLT vaccine over a range of dosages and comparing with three doses of a comparable dosage of oral vaccine. The study subject population is 52 healthy adult male and female subjects, ages 18 to 45. Subject participation duration is approximately 8 months with study duration of approximately 1.5-2 years, including 6-7 months of follow-up.
NCT02052934 Gastroenteritis Escherichia Coli Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine MeSH:Gastroenteritis
A Phase 1 Dose Escalating Study of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Sublingual or Oral Immunization to Determine Safety and Immunogenicity of a Multi-dose Regimen in Adult Humans. --- L211A ---
Primary Outcomes
Measure: Occurrence of solicited reactogenic side effects through Day 8 following each vaccination. Time: Day 0 to Day 8Measure: Occurrence of vaccine-related, non-solicited adverse events (AEs) for facial nerve disturbance through 75 days post third vaccination. Time: Day 29 through Day 104
Measure: Occurrence of vaccine-related, non-solicited adverse events (AEs) through Day 36 following first vaccination. Time: Day 0 to Day 36
Secondary Outcomes
Measure: Occurrence of vaccine-related serious adverse events (SAEs) through 7 months following first vaccination. Time: Day 0 through Day 210Measure: Proportion of subjects with =4-fold rise from the baseline in LT toxin neutralization titers. Time: Days 0, 8, 15, 22, 29, 36, 64 and 85
Measure: Proportion of subjects with >/= 2-fold rise from the baseline in dmLT-specific IgA- and IgG-ALS at any time after vaccination. Time: Days 0, 8, 15, 22, 29, 36, 64, and 85
Measure: Proportion of subjects with >/= 4-fold rise from the baseline in dmLT-specific fecal IgA or >/= 4-fold rise for the ratio of specific over total IgA after vaccination. Time: Days 0, 8, 15, 22, 29, 36, and 64
Measure: Proportion of subjects with >/= 4-fold rise from the baseline in dmLT-specific IgA- and IgG-ALS after vaccination. Time: Days 0, 8, 15, 20, 22, 29, 34, and 36
Measure: Proportion of subjects with >/= 4-fold rise from the baseline in dmLT-specific saliva IgA or >/= 4-fold rise for the ratio of specific over total IgA after vaccination. Time: Days 0, 8, 15, 22, 29, 36, and 64
Measure: Proportion of subjects with >/= 4-fold rise from the baseline in dmLT-specific serum IgA or IgG at any time after vaccination. Time: Days 0, 8, 15, 22, 29, 36, 64, and 85
Measure: Proportion of subjects with >8 IgA- or IgG-ASC/10^6 peripheral blood mononuclear cells (PBMCs) after vaccination. Time: Days 0, 8, 15, 20, 22, 29, 34, and 36
Measure: Proportion of subjects with IgG and IgA dmLT-specific circulating ASC expressing gut homing receptors. Time: Days 0 8, 15, 20, 22, 29, 34, and 36
2 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 Other: Placebo Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine MeSH:Gastroenteritis
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 ---
Primary Outcomes
Measure: Occurrence of solicited adverse events (AEs) Time: 7 Days following each vaccinationMeasure: 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 vaccinationMeasure: 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
3 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
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 Other: Placebo Other: Placebo Other: Placebo Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine Biological: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine MeSH:Gastroenteritis
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 ---
Primary Outcomes
Measure: The occurrence of discontinuation of study vaccination Time: Day 1 up to day 223Measure: 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 223Measure: 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