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The clinical dossier for a phase IIB, double-blind, randomized clinical trial to evaluate the safety and tolerability of ID93+GLA-SE as an adjunct to standard TB treatment has been prepared and submitted on 1st June 2019 by STriTuVaD partner IDRI, Infectious Disease Research Institute. They also revised a protocol for evaluating the safety, tolerability, and immunogenicity of the ID93+GLA-SE vaccine administered to HIV-negative patients during multidrug therapy for drug susceptible and drug resistant pulmonary tuberculosis, as well as development of an in silico database for predicting clinical outcomes as a primary objective. This protocol was submitted to the Drug Controller General of India's office on October 2019.
This study, co-funded by the Horizon 2020 Framework Programme for Research and Innovation and the Department of Biotechnology of India, will be conducted by the All India Institute of Medical Science (AIIMS) in New Delhi.
