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Report for Clinical Trial NCT01147445
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli
infection) is safe. This vaccine will be tested to see what effects it has on the body and
the ability of the vaccine to help the body resist disease. Researchers want to find the
highest dose of dmLT vaccine that can be given without causing severe side effects. Most E.
coli bacteria are harmless to humans and can even be beneficial. However, some are harmful,
and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study.
This study will require volunteers to stay in the research facility for several nights.
Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures
include: stool samples, blood samples, and documenting side effects. Participants will be
involved in study related procedures for about 8 months.
NCT01147445 Gastroenteritis Escherichia Coli
Name: Double Mutant Heat- Labile Toxin (dmLT)
Description: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat labile enterotoxin. LT(R192G/L211A) is formulated as a freeze-dried (lyophilized), white to off-white cake, containing 700 micrograms of vaccine protein in a 3 mL, multi-dose, Wheaton Serum Vial. Vaccine dosage levels: 5, 25, 50, 100 micrograms as a single, oral dose.
Group Labels: 5 Cohort 1: 5 mcg dmLT Cohort 2: 25 mcg dmLT Cohort 3: 50 mcg dmLT Cohort 4: 100 mcg dmLT Cohort 5: 50 mcg or 100 mcg dmLT
Primary Outcomes Measure: Safety of double-mutant E. coli heat labile enterotoxin (dmLT) vaccine. The occurrence of dose escalation halting events. Additional safety includes the incidence and severity of adverse events (AEs) and changes in laboratory and clinical parameters. Time: Day 0, follow-up clinic visits (Days 8 ±1, 14 ±2, 28 ±2), and months 2 ±2 weeks, 6 ±2 weeks, by telephone. After Day 28 post vaccination, adverse event follow-up limited to only SAEs, non-routine medical visits, and new-onset chronic medical conditions.
Secondary Outcomes Measure: Adverse Events. Time: Through 6 months.
Measure: Immunogenicity: stimulation of anti-dmLT antibody secreting cells (ASC) measured by ELISPOT and seroconversion rates and geometric mean titers of serum anti-LT immunoglobulin (Ig) IgG and IgA antibodies and fecal anti-LT IgA antibodies measured by ELISA. Time: Serum and stool collected on Days 8, 14, and 28.
There is one SNP
The rationale for using an E. coli heat
labile enterotoxin (LT) (R192G/L211A) vaccine, also called double-mutant LT (dmLT), is that
it is expected to be especially well tolerated by subjects. --- R192G ---