29 October 2015 MTBVAC Study Commences
The South African Tuberculosis Vaccine Initiative recently vaccinated the first participants in the MTBVAC study, a clinical trial which will evaluate the safety of the novel TB vaccine MTBVAC firstly in adults followed by a dose – escalation trial of the safety and immunogenicity of MTBVAC compared to BCG in newborns.
|Dr Michele Tameris|
According to Dr Michele Tameris, Principal Investigator “This novel vaccine, MTBVAC, has been developed to replace BCG, currently the only registered TB vaccine available and routinely given at birth to all newborns. The first trial of MTBVAC in humans was in 2013 in Switzerland and had very good safety and immunogenicity results.”
“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”. BIOFABRI, a biotechnology company focusing on human health vaccines, is the sponsor of the Phase 1B clinical trial with the TBVI acting as part-sponsor.
MTBVAC was designed by Professor Carlos Martin of the University of Zaragoza. This vaccine will be the first live-attenuated Mycobacterium tuberculosis-based vaccine to start clinical evaluation in newborns and is expected to offer a higher level of protection than BCG.