Vaccine Info

MTBVAC Tuberculosis Vaccine

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Last reviewed
May 25, 2023
Fact checked by
Robert Carlson, MD

MTBVAC Tuberculosis Vaccine May 2023

MTBVAC is a live attenuated vaccine against Mycobacterium tuberculosis (TB) in development. It is currently being developed for two purposes: as a more effective and potentially longer-lasting vaccine than the Bacille Calmette-Guerin (BCG) vaccine for newborns and for preventing TB disease in adults and adolescents. MTBVAC was designed by the genetic research group of Dr. Carlos Martin Montañés of the Department of Microbiology at the University of Zaragoza and Brigitte Gicquel at the Institut Pasteur in Paris.

A study published in 2016 found MTBVAC-vaccinated mice at birth showed enhanced immunogenicity and better protection against M. tuberculosis challenge in comparison with BCG. In January 2021, a study described concordance between immune profiles measured in clinical trials and a macaque pre-clinical study demonstrating significantly improved outcomes after M. tuberculosis challenge as evidence to support the continued development of MTBVAC as an effective prophylactic vaccine for TB vaccination campaigns. On December 8, 2021, a study published by Vaccines found MTBVAC displayed superior efficacy in mice, guinea pigs, NHP, and similar safety compared to BCG.

With support from the European & Developing Countries Clinical Trials Partnership, Biofabri launched a Phase III clinical trial of MTBVAC in neonates in South Africa, Madagascar, and Senegal in late 2022. Under an agreement, IAVI is supporting development, global regulatory strategy, resource mobilization, and access planning for the adolescent/adult MTBVAC program. This includes an efficacy trial, which IAVI plans to begin in 2024 after securing sufficient funding. "The world urgently needs a new, effective vaccine that can prevent TB disease in adults, adolescents, and infants," said Dr. Mark Feinberg, president, and CEO of IAVI, in a press release on May 17, 2023.

Biofabri was founded in 2008 and is part of Zendal, a biopharmaceutical group comprising seven companies focused on researching, developing, manufacturing and marketing high-value-added products in the healthcare industry.

TB Vaccines 2023

There are several versions of the BCG vaccine offered globally.

Tuberculosis Outbreaks

An estimated 10.6 million people worldwide fell ill with TB in 2021, and 1.6 million people died from TB, according to the WHO 2022 Global TB Report. In 2023, numerous countries have confirmed TB outbreaks.


May 17, 2023 - Biofabri and IAVI announced signing an agreement for end-to-end development of the TB vaccine candidate MTBVAC. 

March 24, 2023 - World TB Day was celebrated with the theme 'Yes! We can end TB!'

March 16, 2022 - Bharat Biotech announced the partnership with BIOFABRI, a Spanish biopharmaceutical company, to develop, manufacture and market a new tuberculosis vaccine. The vaccine is being manufactured and developed by BIOFABRI in close collaboration with the University of Zaragoza, IAVI, and the Tuberculosis Vaccine Initiative (TBVI). MTBVAC was designed and discovered by Carlos Martín's team at the University of Zaragoza.

July 23, 2021 - Biofabri launched a Phase III trial of MTBVAC (NCT04975178) in neonates in South Africa, Madagascar, and Senegal. The Estimated Primary Completion Date: June 2027.

August 12, 2019 - The Lancet published: Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomized controlled, double-blind dose-escalation trial. Interpretation: MTBVAC had acceptable reactogenicity and induced a durable CD4 cell response in infants. The evidence of immunogenicity supports the progression of MTBVAC into larger safety and efficacy trials but also confounds the interpretation of tests for M tuberculosis infection, highlighting the need for stringent endpoint definition.

MTBVAC Clinical Trials, number NCT02729571. Findings: Between Sept 29, 2015, and Nov 16, 2015, 62 adults were screened, and 18 were enrolled and randomly assigned, nine each to the BCG and MTBVAC groups. Between Feb 12, 2016, and Sept 21, 2016, 36 infants were randomly assigned—eight to the BCG group, nine to the 2·5 × 103 CFU MTBVAC group, nine to the 2·5 × 104 CFU group, and ten to the 2·5 × 105 CFU group. Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 105 CFU MTBVAC group, with no evidence of local or regional injection-site complications. Systemic adverse events were evenly distributed across BCG and MTBVAC dose groups and were mostly mild in severity. Eight serious adverse events were reported in seven vaccine recipients (one adult MTBVAC recipient, one infant BCG recipient, one infant in the 2·5 × 103 CFU MTBVAC group, two in the 2·5 × 104 CFU MTBVAC group, and two in the 2·5 × 105 CFU MTBVAC group), including one infant in the 2·5 × 103 CFU MTBVAC group treated for unconfirmed tuberculosis and one in the 2·5 × 105 CFU MTBVAC group treated for unlikely tuberculosis. One infant died as a result of possible viral pneumonia. Vaccination with all MTBVAC doses induced durable antigen-specific T-helper-1 cytokine-expressing CD4 cell responses in infants that peaked 70 days after vaccination and were detectable 360 days after vaccination. For the highest MTBVAC dose (ie, 2·5 × 105 CFU), these responses exceeded responses induced by an equivalent dose of the BCG vaccine up to 360 days after vaccination. Dose-related IGRA conversion was noted in three (38%) of eight infants in the 2·5 × 103 CFU MTBVAC group, six (75%) of eight in the 2·5 × 104 CFU MTBVAC group, and seven (78%) of nine in the 2·5 × 105 CFU MTBVAC group at day 180, compared with none of seven infants in the BCG group. By day 360, IGRA reversion had occurred in all three infants (100%) in the 2·5 × 103 CFU MTBVAC group, four (67%) of the six in the 2·5 × 104 CFU MTBVAC group, and three (43%) of the seven in the 2·5 × 105 CFU MTBVAC group.

Clinical Trials

No clinical trials found