Phase 2a Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Healthcare Workers

Summary

The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM) injections one month apart in healthy healthcare workers. The healthcare workers will all have had the childhood TB vaccine called BCG, and all of them must have a negative result for a blood test for exposure to the bacteria that cause TB (QuantiFERON-TB Gold Plus, or "QFT"). Study participants will be followed for 12 months after the last injection for safety reasons. Blood will be drawn for laboratory tests for safety, immunogenicity, and efficacy tests. Efficacy will be evaluated by further QFT testing. The study hypothesis is that the vaccine is safe, immunogenic, and effective in this study population.

Timeline

Start

2018-05-31

Primary completion

2020-03

Completion

2020-06

Publications

• Choi YH, Kang YA, Park KJ, Choi JC, Cho KG, Ko DY, Ahn JH, Lee B, Ahn E, Woo YJ, Jung K, Kim NY, Reese VA, Larsen SE, Baldwin SL, Reed SG, Coler RN, Lee H, Cho SN. Safety and Immunogenicity of the ID93 + GLA-SE Tuberculosis Vaccine in BCG-Vaccinated Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Infect Dis Ther. 2023 Jun;12(6):1605-1624. doi: 10.1007/s40121-023-00806-0. Epub 2023 May 11.

Drugs

Indications