Phase 1 Study of dmLT ID Vaccination in Healthy Adults

Summary

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.

Timeline

Start

2016-06-02

Primary completion

2020-05-04

Completion

2020-05-04

Publications

• Pasetti MF, Milletich PL, White JA, Butts J, Brady RC, Dickey MD, Ballou C, Maier N, Sztein MB, Baqar S, Louis Bourgeois A, Bernstein DI. Safety and immunogenicity in humans of enterotoxigenic Escherichia coli double mutant heat-labile toxin administered intradermally. NPJ Vaccines. 2025 Feb 1;10(1):23. doi: 10.1038/s41541-025-01071-7.

Drugs

Indications