Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial

Lancet Respiratory Medicine
Apr 2018 Volume 6 Number 4 p231-314  e11-e15
http://www.thelancet.com/journals/lanres/issue/current
Articles
Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial
Adam Penn-Nicholson, Michele Tameris, Erica Smit, Tracey A Day, Munyaradzi Musvosvi, Lakshmi Jayashankar, Julie Vergara, Simbarashe Mabwe, Nicole Bilek, Hendrik Geldenhuys, Angelique Kany-Kany Luabeya, Ruth Ellis, Ann M Ginsberg, Willem A Hanekom, Steven G Reed, Rhea N Coler, Thomas J Scriba, Mark Hatherill the TBVPX-114 study team
Interpretation
Escalating doses of ID93 + GLA-SE induced similar antigen-specific CD4-positive T cell and humoral responses, with an acceptable safety profile in BCG-immunised, M tuberculosis-infected individuals. The T-cell differentiation profiles in M tuberculosis-infected vaccinees suggest priming through natural infection. While cohort sample sizes in this phase 1 trial were small and results should be interpreted in context, these data support efficacy testing of two administrations of the lowest (2 μg) ID93 vaccine dose in tuberculosis endemic populations.
Funding
Aeras and the Paul G Allen Family Foundation