Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults

Summary

This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).

Timeline

Start

2018-10-02

Primary completion

2020-06-15

Completion

2020-06-15

Publications

• Results Sagawa ZK, Goman C, Frevol A, Blazevic A, Tennant J, Fisher B, Day T, Jackson S, Lemiale F, Toussaint L, Kalisz I, Jiang J, Ondrejcek L, Mohamath R, Vergara J, Lew A, Beckmann AM, Casper C, Hoft DF, Fox CB. Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults. Nat Commun. 2023 Mar 6;14(1):1138. doi: 10.1038/s41467-023-36789-2.

Drugs

Indications