STriTuVaD Clinical Trial of RUTI® Vaccine for Tuberculosis: First Patients Recruited at AIIMS, India
The Spanish biotech company Archivel Farma has officially begun the clinical trial of its therapeutic vaccine RUTI®, which will be carried out by Clinical Research Network India, a Contract Research Organization specializing in clinical research.
The double-blind, randomized, placebo-controlled phase IIb clinical trial will investigate the efficacy of RUTI® as adjuvant of Tuberculosis (TB) chemotherapy
and will recruit 90 patients with TB and 50 patients with multi-drug resistant TB (MDR-TB). The clinical trials will be conducted in two centers in India: the All India Institute Of Medical Sciences (AIIMS) of New Delhi, and the Agartala Government Medical College of Agartala. The first patient in the trial has been recruited on 30 September, 2021 at the All India Institute Of Medical Sciences of New Delhi in India.
The congress took place on the 19th and 20th October 2021, and the simulation platform to predict the effects of vaccines on tuberculosis patients has been presented by partners from the University of Catania during the Immune Profiling session.
At the beginning of September 2021, the Clinical Research Organization (CRO) visited the facilities and met the personnel that will collaborate on the clinical trials for RUTI therapeutic vaccine. The CRO confirmed that the vaccine was ready on site and all the source documents and regulatory documents were completed.
by Robert Cooke, Marketing and Communications Manager @ The University of Sheffield Therapies for tuberculosis exist, but they can take a long time to be effective and are expensive to administer. With one third of the world's population already carrying the infection, mostly in developing countries, the need for alternative treatments is urgent. But bringing new drugs to market would only take more time and more money, both of which are in short supply. [...] This is where STriTuVaD’s Universal Immune System Simulator (UISS) for Tuberculosis comes in. Using a system developed by consortium member Professor Francesco Pappalardo at the University of Catania, researchers can gather data from a much smaller number of patients
than would normally be needed for a full-scale clinical trial. With this, it is possible to use statistical modelling to generate 'virtual patients' and predict their response to the therapy being tested. These predictions are combined with observations made on real patients using a new augmented clinical trial approach that applies principles from Bayesian statistics for a continuously refined dataset.
“Along with my postdoctoral research associate, Dimitris Kiagias, I lead the mathematical modelling that enables sharing information from the computer and physical patients into an augmented clinical trial, - says Dr Miguel Juárez, lecturer at the University of Sheffield - this entails measuring the compatibility of the simulation's output with the real data, in order to weigh its contribution to the combined experiment, while identifying and propagating the variability from both sources onto the assessment of the trial endpoints. Read full interview
Authored by our partners from the University of Sheffield and the University of Catania, the paper proposes a Bayesian hierarchical method for combining in silico and in vivo data onto an augmented clinical trial: it incorporates new virtual patients sequentially without overwhelming the information from in vivo trial. Read the full paper
Partners from the University of Catania investigated cross-reactivity in relation to the possibility of finding existing vaccines that could elicit the human immune system response to SARS-CoV-2 and found that vaccines for treating diphtheria, tetanus, and pertussis infectious diseases (DTP) are significant sources of potential cross-reactive immunity to SARS-CoV-2. Read the full paper