A Phase IIb Clinical Trial application of the Inactivated Therapeutic Tuberculosis Vaccine RUTI® entitled “Double-Blind, Randomized, Placebo-Controlled Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as adjuvant of Tuberculosis chemotherapy”, was successfully submitted to Drug Controller General of India's office on Thursday 9th May 2019.
RUTI® vaccine has already demonstrate to be clinically safe and immunogenic in a Phase I study conducted in healthy volunteers in Europe* and in a Phase II study conducted in South Africa in patients with Latent Tuberculosis Infection**.
This study will be conducted under the STriTuVaD Consortium which is being co-funded by the Horizon 2020 Framework Programme for Research and Innovation and the Department of Biotechnology of India.
The Sponsor for the clinical trial is the biotechnology company Archivel Farma S.L. of Barcelona (Spain). The clinical study will be conducted by the All India Institute of Medical Science (AIIMS) in New Delhi and will enroll a total of 140 patients with drug-susceptible tuberculosis (DS-TB) and multidrug resistant tuberculosis (MDR-TB).
It is expected that the authorization will come up by October-November 2019.
*(Report Number: CT 2006-000690-29, Protocol Code: FA/MI/01, dated 24 October 2008)
**(EudraCT number 2007-005934-35; Clinical Study Number RUTISAPH2, Version Number: 1.0, dated: 30 May 2012)