Cape Town – The South African Tuberculosis Vaccine Initiative (Satvi), biopharmaceutical company Biofabri, the University of Zaragoza in Spain and the TuBerculosis Vaccine Initiative (TBVI) announced promising new safety and immunogenicity results for tuberculosis (TB) vaccine for infants.
Research on the live, attenuated Mycobacterium TB vaccine, MTBVAC, in South African infants, appeared in The Lancet Respiratory Medicine journal this week.
This Phase 1b study, conducted in a TB endemic community, showed that vaccination of infants with
MTBVAC displayed a similar safety profile and had indistinguishable
reactions at the injection site to that of the current licensed TB vaccine,
Bacille Calmette-Guérin (BCG), which has an excellent safety record.
Vaccination with MTBVAC induced a long-lasting immune response of greater magnitude than that of BCG at a comparable dose. This promising data supports further progression of MTBVAC through
ongoing Phase 2a dose-defining
studies and into large-scale infant
efficacy trials.
Satvi director Professor Mark Hatherill said: “These exciting results are an important step towards a more effective TB vaccine, and support
plans for a much larger trial to better define the safety and efficacy of
MTBVAC in infants living in TB endemic countries.”
Satvi immunology deputy director Professor Tom Scriba explained the results from this trial showed that MTBVAC was capable of inducing robust and durable immune responses and trigger the next stage of evaluation for this vaccine candidate.
According to Biofabri general manager Esteban Rodríguez, in
2008, Biofabri acquired the c
ommitment to make available the MTBVAC vaccine worldwide at an affordable price.
Such a commitment enhances Biofabri’s involvement in the fight against TB, particularly in low income countries.
Carlos Martin of the University of Zaragoza said the next step was to demonstrate the efficacy of MTBVAC in TB endemic countries.
“The sooner we can show the efficacy of MTBVAC in clinical trials, the earlier MTBVAC could help us save millions of lives,” Martin said.
Jelle Thole of TBVI said a new vaccine against TB was urgently needed for all age groups.