Biofabri’s TB vaccine collaboration presses ahead with vaccine trial

A collaboration between Biofabri, a non-profit organisation, and academics from South Africa are pressing ahead with clinical development of a novel tuberculosis vaccine candidate known as MTBVAC.

Biofabri, part of the Spanish biopharma group Zendal, is working with the non-profit organisation IAVI, and the South African Tuberculosis Vaccine Initiative (SATVI) on the vaccine derived from a strain of TB found in humans.

BCG, the only TB vaccine currently used for prevention is derived from bovine, rather than human strains of the bacteria.

It is effective in preventing severe TB disease in infants and children but only has variable effectiveness in adults.

MTBVAC is a live weakened (attenuated) form of Mycobacterium tuberculosis and developers think this could be more effective in preventing TB disease than BCG, and because it is attenuated does not have the ability to cause disease in healthy people. A phase 1a trial showed that MTBVAC demonstrated a similar safety profile to BCG at a similar dose.

The clinical trial, designated A-050, is a Phase 1b/2a safety and dose-finding study designed to test different doses of MTBVAC, and will also collect additional safety and immunogenicity information in healthy adults with and without evidence of having been previously infected with TB bacteria.

It may also show whether vaccination with MTBVAC produces an immune response distinct from the response to BCG.

In A-050, up to 144 participants at the SATVI trial site in Worcester, South Africa, will receive either one administration of MTBVAC at different doses or BCG at the standard adult dose.

Participants will be monitored for safety and immune response for 12 months after vaccination and results from A-050 are due in 2020.

The vaccine originated from researchers at the University of Zaragoza in Spain, while Biofabri is the vaccine candidate sponsor.

IAVI is the trial sponsor with funding from the US National Institutes of Health and the US Department of Defense.

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