TBVI: Pursuing a Vaccine to Prevent the World’s Deadliest Infectious Disease

Technology: MTBVAC

Product type: Vaccine

Disease: Tuberculosis

Tuberculosis is the world’s deadliest infectious disease, killing 1.4 million each year.[i] Yet, the only vaccine against TB in use today, Bacille Calmette-Guerin (BCG), is a live attenuated strain from a Mycobacterium bovis strain isolated from cattle and discovered nearly 100 years ago. BCG is administered at birth, and despite its effectiveness in reducing the incidence of forms of TB in children, it is inconsistent in preventing pulmonary TB, the most common form of the disease in adolescents and adults, and the form most responsible for transmission of TB.

In 1993, WHO declared TB a global emergency, prompting several funders to invest in R&D efforts to develop new TB vaccines to address this global epidemic. Much of this investment was in PDPs. Today’s global TB vaccine pipeline contains several promising vaccine candidates. With adequate institutional, technical, and funding support, the first new TB vaccines could be available as early as 2026 to 2028.

Since the early 2000s, Tuberculosis Vaccine Initiative (TBVI) has supported several collaborative research projects for the development of promising TB vaccine candidates. Among the most advanced and most promising new candidates is the MTBVAC TB vaccine.

“TBVI, over the last 10-plus years has used the PDP model to accelerate the most promising TB vaccine candidates through the pipeline—such as MTBVAC— and aims to continue to innovate and diversify both the global tuberculosis vaccine pipeline and TB vaccine platforms via the same PDP approach.”

—DR. NICK DRAGER, EXECUTIVE DIRECTOR TBVI

MTBVAC is a live rationally attenuated derivative of the M. tuberculosis isolate MT103, which belongs to Lineage 4 (Euro-American), one of the most widespread lineages of M. tuberculosis. MTBVAC has been the first and only live attenuated M. tuberculosis vaccine approved to enter into clinical trials. A first-in-human MTBVAC clinical trial was conducted successfully in healthy adults in Lausanne (Switzerland). Subsequent clinical trials in TB endemic regions (South Africa, Mozambique) are currently ongoing, and a Phase III trial to test the projected efficacy of the MTBVAC vaccine is scheduled to start in 2021.

MTBVAC is a true example of successful international collaboration in the PDP area. R&D progress on the MTBVAC candidate has been made possible due to support from and collaboration between universities and research institutions (University of Zaragoza, Institut Pasteur Paris, and the broader TBVI research organization community), private industry (Spanish vaccine company, Biofabri), public funders (European Commission/EU Framework Programmes, DFID UK Government, NORAD Norwegian Government), and private funders (Bill & Melinda Gates Foundation) and PDPs (TBVI and IAVI).

The MTBVAC TB vaccine candidate is being developed for infants as well as adolescents and adults. If development plans proceed as planned, the MTBVAC could be ready to enter the market as a vaccine for infants as early as 2026, and for adolescents and adults as early as 2028–2030

PROGRESS IN TUBERCULOSIS VACCINE R&D GLOBAL PIPELINE OVERVIEW

PDPs have played a pivotal role in building a strong global portfolio of TB vaccine candidates. Before the emergence of PDPs, there were no vaccine candidates in development. Today, there are 20, with a third of them in late-stage development. Five of those late-stage candidates have been supported by TBVI, Aeras, or IAVI.

i. Global tuberculosis report 2020. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO