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

Summary

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.

Timeline

Start

2019-03-10

Primary completion

2020-12-31

Completion

2020-12-31

Outcome

Outcome not reported

Stopped: “COVID 19 cases at the site”

Publications

• Bhuiyan TR, Khanam F, Basher SR, Dash P, Chowdhury MI, Haque S, Harun NB, Akter A, Karmakar PC, Hakim A, Amin S, Kamruzzaman M, Parvin N, Ahmed T, Butts J, Pasetti MF, Wahid R, Sztein MB, Maier N, White JA, Tomashek KM, Bourgeois AL, Baqar S, Kotloff KL, Qadri F, Chen WH. Safety and immunogenicity of a recombinant double-mutant heat-labile toxin derived from enterotoxigenic Escherichia coli in healthy Bangladeshi adults delivered by three different routes. Front Bacteriol. 2025;4:10.3389/fbrio.2025.1567791. doi: 10.3389/fbrio.2025.1567791. Epub 2025 Jul 15.

Drugs

Indications