The novel vaccine candidate against tuberculosis, MTBVAC, initiates Phase 1B clinical trial

Porriño, 17 September 2015 -- Biofabri, the University of Zaragoza and SATVI today announced that for the tuberculosis vaccine candidate MTBVAC the Phase 1B clinical trial in South Africa has successfully started. Biofabri will be the sponsor  of this 1B Phase clinical trial. The trial is partly supported by TBVI.

“This clinical trial is a very important step in the development of the vaccine and it will be sponsored by Biofabri” said Esteban Rodríguez, CEO of Biofabri. “MTBVAC will be the first vaccine to be fully developed in Spain”.

The trial is being led by Dr Michele Tameris, the Principal Investigator from SATVI. This study would commence middle of September 2015 and will be conducted over a two year period where after the research findings will be published. This clinical trial is designed to evaluate the safety and immunogenicity of MTBVAC vaccine in new-borns. Previously, in 2013 the vaccine was included in a phase IA trial in adults in Switzerland.

The Medicines Control Council (MCC) and Department of Agriculture, Forestry and Fisheries have granted permission to initiate a Phase 1B clinical trial for the Spanish vaccine candidate designed by Biofabri with the strain MTBVAC from the University of Zaragoza. This vaccine will be the first live-attenuated Mycobacterium tuberculosis-based vaccine to start clinical evaluation in new-borns.

The new vaccine is expected to offer a higher level of protection than the BCG vaccine.

Phase 1B Clinical Trial
Sponsored by: Biofabri, S.L.
Place: South African Tuberculosis Vaccine Initiative (SATVI). Western Cape, South Africa
Investigator: Dr Michele Tameris

About MTBVAC

MTBVAC is made from a strain isolated from humans and was designed by Professor Carlos Martín, Director of the Mycobacterial Genetics Research Group of the University of Zaragoza. The research group is part of the Spanish Network of Centres for Biomedical Research of Respiratory Diseases (CIBERES), headed by Dr. Carlos Martín Montañés, and has worked in close collaboration with Dr. Brigitte Gicquel, from the Pasteur Institute in Paris. The BCG vaccine protects against various forms of tuberculosis in children, but its efficacy rate for pulmonary tuberculosis in adults varies widely, ranging from 0 to 80 percent.

MTBVAC stimulates the immune system to enable it to recognise the infectious agent and offer long-term protection against the most common form of tuberculosis: pulmonary tuberculosis.

About Biofabri

Biofabri is a biopharmaceutical company with a vision for the future that in 2008 decided to focus on the research, development and production of human vaccines.

C&B GROUP is a 100% Spanish business group formed by CZ Veterinaria and Biofabri that specializes in biotechnology products.

www.biofabri.es

About TBVI

The TuBerculosis Vaccine Initiative (TBVI) is a non-profit foundation that facilitates the discovery and development of new, safe and effective TB vaccines that are accessible and affordable for all people.  As a Product Development Partnership (PDP), TBVI integrates, translates and prioritises R&D efforts to discover and develop new TB vaccines and biomarkers for global use. TBVI provides essential services that support the R&D efforts of its consortium partners – 50 partners from academia, research institutes and private industry in the TB vaccine field.

www.tbvi.eu     

About SATVI

The South African Tuberculosis Vaccine Initiative (SATVI) is a research group at the University of Cape Town.
The mission of SATVI is the development of new and effective vaccination strategies against tuberculosis (TB).

Source: TBVI