SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02052934

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH: Gastroenteritis

2 Interventions

Name: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

Description: Attenuated, Recombinant Double Mutant Heat-Labile Toxin (dmLT) from Enterotoxigenic Escherichia coli (ETEC), LT(R192G/L211A); lot 1575. Subjects in 5 cohorts receive 3 doses ranging from 1 mcg to 50 mcg.

Type: Biological

Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 5a

Name: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

Description: Attenuated, Recombinant Double Mutant Heat-Labile Toxin (dmLT) from Enterotoxigenic Escherichia coli (ETEC), LT(R192G/L211A); lot 1575. Subjects in 5b cohort receive 3 doses of 25 mcg.

Type: Biological

Cohort 5b


Primary Outcomes

Measure: Occurrence of solicited reactogenic side effects through Day 8 following each vaccination.

Time: Day 0 to Day 8

Measure: 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 210

Measure: 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

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L211A

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 ---



HPO Nodes