NCT02052934

Safety of Sublingual dmLT for ETEC

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Despite the public health burden of Enterotoxigenic Escherichia coli (ETEC) on travelers, deployed soldiers and, most significantly, young children in the developing world, there is no licensed vaccine against ETEC enteritis.This is a Phase 1 study in healthy adults to determine the safety and immunogenicity of an ETEC candidate vaccine, attenuated recombinant dmLT from ETEC, administered by the SL (Sublingual) or Oral Immunization. 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. Potential risks include subjects could develop varying degrees of diarrhea or other gastrointestinal symptoms (such as nausea, abdominal pain or cramping, gas, and decreased appetite). Blood drawing may be associated with pain and bruising at the site and rarely, with fainting or seizure. There is no direct benefit to subjects from participating in this study but the potential benefits to children and adults who may receive a future beneficial vaccine based on the results of this trial justify the more than minimal risk of the subjects who will participate in this trial. The primary objective is to 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 are to assess long-term safety follow-up from immunization through Month 7 post vaccination, and following three SL doses of dmLT vaccine over a range of dosages and comparing with three doses of a comparable dosage of oral vaccine.

Conditions

• Gastroenteritis Escherichia Coli

Interventions

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

Timeline

• Start date: 2014-03-10
• Primary completion: 2016-11-02
• Completion: 2016-11-02
• First posted: 2014-02-03
• Last updated: 2019-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study